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The global generic pharmaceuticals market is likely to witness strong growth in the next few years owing to the patent expiration of key blockbuster drugs and the judicious cost containment efforts of governments and healthcare service providers worldwide. At the same time, the balance in terms of healthcare expenditure and sales revenue is poised to shift from developed to emerging markets such as India, China, Brazil, Russia, Turkey and South Korea, as huge potential still remains untapped in these countries.



Popular drugs scheduled to lose U.S. market protection between 2013 and 2018:reader keep watching this post , I will keep updating with new info


Drugs worth an estimated $103 billion lost their patents between 2009 and 2012 with a further $29 million loss expected in 2013.(Source: DTTL Global Life Sciences and Health Care Industry Group analysis of Global Generic, Cygnus)

Some large pharmaceutical companies like Bristol Myers, Pfizer, Eli Lilly and Merck have prepared by buying smaller biotech companies that offer interesting alternatives to their drug pipelines, suggesting a refocus on recruitment in these developing areas.

Many are looking to replace their blockbuster money-spinners with smaller, more targeted treatments. A strong skills requirement for these new inventions is a positive move for some sectors.

A swift move in to emerging markets like Brazil, India and China and alternative business models means a more dynamic global recruitment drive and a greater effort to match skills, new locations and business management as quickly as possible.

Niche products – including so-called orphan drugs – are attractive but leave these larger companies looking at a loss if they can’t convince their local regulatory body that a branded version is more commercially viable than the generic alternative.

So is it the generic drug development projects that will see the biggest impact on Life Science recruitment in the next 18 months? Or will it be established ‘big pharma’ companies moving in to emerging markets?


The global pharmaceutical market is witnessing a change as many patents of key blockbuster drugs have expired in last few years. The patent expiration of blockbuster drug fuel the growth of global generic drug pharmaceutical market. Many branded pharmaceutical companies drugs expired in last few years like Lipitor, CozaarConcerta,CrestorLevaquin and Zyprexa. Market leaders such as TevaSandoz and Mylan are increasingly focused on generics, as this segment provides a competitive edge and presents huge profit margins. Patent expiration opens the door for generic versions which make the healthcare available to the consumers at cheaper costs as compared to the patented drugs.

for information to readers

According to IBISWorld, the top five best-sellers set to lose patent protection in each of the yrs 2011 and 2012 were


Patent Expiring in 2011 Condition Company 2010 U.S. Sales
Lipitor cholesterol Pfizer $5,329,000,000
Zyprexa antipsychotic Eli Lily $2,496,000,000
Levaquin antibiotics Johnson & Johnson $1,312,000,000
Concerta ADHD/ADD Johnson & Johnson $929,000,000
Protonix antacid Pfizer $690,000,000


Patent Expiring in 2012 Condition Company 2010 U.S. Sales
Plavix anti-platelet Bristol-Myers Squibb /Sanofi-Aventis $6,154,000,000
Seroquel antipsychotic AstraZeneca $3,747,000,000
Singulair asthma Merck $3,224,000,000
Actos type 2 diabetes Takeda $3,351,000,000
Enbrel arthritis Amgen $3,304,000,000

Animasi KimiaLinks

YEAR 2013


Epoetin alfa (rINN/ɛˈp.ɨtɨn/ is human erythropoietin produced in cell culture using recombinant DNA technology. Authorised by the European Medicines Agency on 28 August 2007, it stimulates erythropoiesis (increases red blood cell levels) and is used to treat anemia, commonly associated with chronic renal failure and cancer chemotherapy. Epoetin is marketed under the trade names Procrit and Epogen. Its annual cost to U.S. patients was $8,447 per patient per year in 2009

Amgen being the most hard hit of all the companies. Its blockbuster drug for anemia, Epogen, which had a sale of about  $2.5 billion (12,500 crore) in 2008, will lose its patent in 2013.





enfuvirtide, fuzeon

Enfuvirtide (INN) is an HIV fusion inhibitor, the first of a novel class of antiretroviral drugs used in combination therapy for the treatment of HIV-1 infection. It is marketed under the trade name Fuzeon (Roche).

Enfuvirtide therapy costs an estimated US$25,000 per year in the United States. Its cost and inconvenient dosing regimen are factors behind its use as a reserve, for “salvage” therapy in patients with multi-drug resistant HIV.USD 43 IN 2008



Oxycontin (oxycodone HCI), an opioid for pain management, earned $2.8 billion in sales in 2011 for its U.S. manufacturer, Purdue Pharma LP.



AcipHex (rabeprazole sodium), for heartburn associated with acid reflux disease, manufacturer: Eisai Inc. and Janssen Pharmaceuticals, Inc.



Zometa (zoledronic acid) injection is a treatment for hypercalcemia of malignancy caused by high calcium blood levels due to cancer; $1.5 billion in global sales in 2010. Manufactured by Novartis.


Xeloda (capecitabine) is an oral chemotherapy treatment for metastatic colorectal and breast cancer manufactured by Genentech/Roche. U.S. sales were growing by double digits annually to reach $647.6 million in 2011.


Oplana ER (oxymorphone HCI), an opioid agonist approved for management of moderate to severe pain, manufactured by Endo Pharmaceuticals Inc. Sales in 2011 were $384.7 million.



Asacol (mesalamine), for the treatment of ulcerative colitis symptoms, earned $800 million in worldwide sales in 2010. Manufacturer: Warner Chilcott


Another blockbuster drug Neupogen will lose its patent in 2013

Filgrastim is a granulocyte colony-stimulating factor (G-CSF) analog used to stimulate the proliferation and differentiation ofgranulocytes. It is produced by recombinant DNA technology. The gene for human granulocyte colony-stimulating factor is inserted into the genetic material of Escherichia coli. The G-CSF then produced by E. coli is different from G-CSF naturally made in humans.

Filgrastim is marketed under several brand names, including Neupogen (Amgen), Imumax (Abbott Laboratories), Grafeel (Dr. Reddy’s Laboratories), Neukine (Intas Biopharmaceuticals), Emgrast (Emcure Pharmaceuticals), Religrast (Reliance Life Sciences), Zarzio (Sandoz), Nufil (Biocon) and others.

Apricus Biosciences is currently developing and testing a product under the brand name Nupen which can deliver filgrastim through the skin to improve post-chemotherapy recovery of neutrophil counts.





Dermatoses $98.6 million December 2013 


Avonex (interferon β-1α)

Patent Expires: December 31, 2013

Sales: $ 2.9 billion

Back in 2009, Biogen Idec Corporation (Biogen Idec) to apply for an extension of the multiple sclerosis drug Avonex key patents for 13 years, however, will still EvaluatePharma drug listed in this year patent protection period has expired drugs list. The agency believes that the patent is this basic structure of the compound, a number of new drugs will enter the market next year. Biogen Idec is developing treatments for multiple sclerosis drug BG-12 (dimethyl fumarate) is about to get FDA approval, the smooth realization of product changeovers.

Trade Name: Avonex
Generic Name: Interferon beta-1A
The Company: Biogen Idec
Indication: Multiple sclerosis (MS)
Patent expiration Date: Dec. 31, 2013
Estimated Global Sales 2012: $ 2.9 Billion


 IHS Healthcare and Pharma key patent expirations 2013

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YEAR 2014

Micardis (telmisartan)

Boehringer Ingelheim’s angiotensin II receptor antagonist telmisartan is approved to treat hypertension and reduce the risk of cardiovascular events. With net sales of $17 billion reported in 2008, the firm will be looking to protect and extend the patent for this first drug in its class to reduce the risk of heart attack and stroke. Even with a black box warning advising against use during pregnancy, there is huge interest in the potential of the product; over 90 clinical trials have been or are being conducted to investigate its use in various patient groups, drug combinations and for other disease states.

KLONOPIN®<br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /><br /> (doxercalciferol) Structural Formula Illustration

Hectorol (doxercalciferol)

Genzyme’s doxercalciferol, used to maintain consistent serum concentrations of vitamin D hormone, is approved for secondary hyperparathyroidism, and was acquired when the firm bought Bone Care International to gain products for kidney disease. Trials testing the drug for osteoporosis and prostate cancer are also underway. Sales, posted at $128 million in 2008, should be enhanced by the introduction of a vial formulation to replace a more awkward glass ampoule as well as a 1mcg capsule. Genzyme is actively defending its patent protections; in July 2009 the company sued the Sandoz unit of Novartis for alleged infringement.

TEMODAR (temozolomide) Structural Formula Illustration


Temodar, temozolomide, dollar 228 million in 2008





Nexium (esomeprazole) for the treatment of gastroesophageal reflux disease (GERD) is manufactured by AstraZeneca. Global sales in 2010 were $4.9 billion.

AstraZeneca’s esomeprazole, indicated for acid reflux and erosive esophagitis, has held its own in sales among other branded products such as Prevacid, and remains one of the world’s largest selling drugs. This may not last. The advent of generics for the same indications, now accounting for 40% of marketed products, have cut into Nexium’s market share for the “purple pill” – which last year amounted to $5.9 billion. The proton pump inhibitor’s patent history is somewhat controversial, generating some charges that this enantiomer of omeprazole provides little advantage or change but is an attempt to “evergreen” the product. In the end, though, it’s an attractive market, and AstraZeneca has already brought the Indian firm Lupin to court, alleging patent infringement. Barring successful patent challenges from other firms, the first generic on the market will be Ranbaxy, licensed in 2008 by AstraZeneca to begin distribution six months before patent expiration. Finally, esomepazole carries two patents not expiring until 2018, and the trade press has wondered if these are an ace up AstraZeneca’s patent lawyers’ sleeves.




Cymbalta (duloxitine HCI), manufactured by Eli Lilly, is for the treatment of depression, generalized anxiety disorder, diabetic nerve pain, fibromylagia and chronic musculoskeletal pain. Global sales exceeded $4 billion in 2011.





Celebrex (celecoxib) is for the treatment of osteoarthritis and rheumatoid arthritis symptoms and management of acute pain in adults. Pfizer, its manufacturer, reported sales of $2.5 billion in 2011.

Marketed by Pfizer, celecoxib, a COX II inhibitor, is indicated for arthritis pain, other acute pain, and primary dysmenorrhea. It is also marketed as Onsenal for familial adenomatous polyps. Available already as a generic in India and the Philippines, the drug was originally developed by Searle and co-promoted by Pfizer and Monsanto (whose research division was eventually acquired by Pfizer). Searle had already prevailed in a patent suit with The University of Rochester, and with Vioxx’s market withdrawal in 2004, Celebrex enjoyed a large market share, even with a clinical trial underway investigating the cardiovascular risks now described in a black box warning. Pfizer expected patent exclusivity until 2015, but a Federal Circuit court, siding with Teva, invalidated the patent in question and resulted in the loss of approximately 18 months of patent protection for Pfizer. Watch for generics on May 30, 2014, when the pediatric exclusivity expires.



Maxalt, rizatriptan, USdollar 224 in 2008

Maxalt® rizatriptan exp2014-02 Migraines MERCK

Budesonide Structural Formula Illustration


Formoterol Fumarate Dihydrate Structural Formula Illustration

formoterol fumarate dihydrate

Symbicort (budesonide/formoterol fumarate dihydrate) for asthma and COPD is manufactured by AstraZeneca. Sales of Symbicort were $3.1 billion in 2011.

Lunesta (Eszopiclone), a treatment for insomnia, is manufactured by Sunovion Pharmaceuticals Inc., a subsidiary of Dainippon Sumitomo Pharma Co. Ltd. Global sales in 2010 were $631 million.


Restasis (cyclosporine ophthalmic emulsion) for increasing tear production in patients with chronic dry eyes, is manufactured by Allergan. In 2010, worldwide sales reached $621 million.

Evista (raloxifene HCI), manufactured by Eli Lilly, is for treating and preventing osteoporosis. Evista earned $1.3 billion in global sales in 2010.


Sandostatin (octreotide) amino acid sequence - illustration

xCH3COOH           where x = 1.4 to 2.5
The molecular weight of octreotide acetate is 1019.3 (free peptide, C49H66N10O10S2) and its amino acid sequence is as above

Sandostatin LAR (octreotide acetate for injectable suspension) by Novartis, is for the treatment of acromegaly syndrome, a hormonal disorder, and severe diarrhea and flushing associated with metastatic cancers. Global sales were $1.3 billion in 2010.

Actonel (risedronate) is for the prevention and treatment of osteoporosis. In 2010, worldwide sales were $1.6 billion. Actonel is manufactured by Warner Chilcott.



Avelox, moxifloxacin. us dollar 500 on 2008






Eptifibatide, CAS# 188627-80-7, is an antiplatelet agent. Also offered from LGM Pharma as a TEVA API (TAPI) product for compounding purposes, eptifibatide is also known by the brand name Integrilin, which is marketed by Merck. With Merck’s patent for Integrilin due to expire on November 11, 2014, and an additional patent revision due to expire on May 5, 2015, this powerful drug is set to be a generic blockbuster. – 


TEVETEN® (eprosartan mesylate) is a non-biphenyl non-tetrazole angiotensin II receptor (AT1) antagonist. A selective non-peptide molecule, TEVETEN® is chemically described as the monomethanesulfonate of (E)-2-butyl-1 -(p-carboxybenzyl)-α-2-thienylmethylimid-azole-5 -acrylic acid.

Its empirical formula is C23H24N2O4S•CH4O3S and molecular weight is 520.625. Its structural formula is:

Teveten (Eprosartan Mesylate) Structural Formula Illustration



US 5656650 exp Aug 12, 2014






Prevention of Organ Transplant Rejection 

$231 million January 2014

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YEAR 2015

BARACLUDE® (entecavir) Structural Formula Illustration

BARACLUDE® is the tradename for entecavir

Baraclude – After Plavix, Baraclude is the next significant challenge that BMS will have to face immediately. It is used in the treatment of chronic hepatitis B infection and fetched almost $1.4 billion in revenues for the firm in 2012. In February 2013, the composition of matter patent covering this drug was invalidated by the U.S. district court for the district of Delaware. Originally, the patent was scheduled to expire in 2015, but now the drug may face generic competition in the U.S. as early as in 2013. The firm will continue to sell in other parts of the world without competition from generic drugs until 2016.

Structural formula of aripiprazole

Abilify (aripiprazole) by Bristol-Myers Squibb is an anti-psychotic used to treat the symptoms of schizophrenia and bipolar disorder. In 2010, global sales reached $4.6 billion.

Included here because of its original patent expiration in 2014, Bristol-Myers has won a pediatric exclusivity extension for aripiprazole until April, 2015…unless Teva prevails in its patent challenge initiated in 2007. Judging by the product’s growth rate, watch for more patent challenges – in 2009, the product yielded $606 million – a 31% jump over the previous year. Indicated for bipolar disorders, schizophrenia, autism and as an add-on to an antidepressant, aripiprazole was recently approved for treatment of children over 10 for bipolar disorder, and the product carries the expected atypical antipsychotic black box warnings for suicidal thoughts in children and young adults.

 The antipsychotic and anti-depressant drug is the next bestselling drug after Plavix. The drug was developed by Otsuka in Japan, and it markets the drug in partnership with BMS in the U.S and Europe. The drug brought in $2.8 billion in revenues for BMS in 2012. However, BMS’s rights to commercialize the drug in EU and U.S. will end in 2014 and 2015 respectively. Simultaneously, Otsuka’s U.S. patent for the drug expires in 2014, and the drug will face competition from generic products soon.



(Glu, Ala, Lys, Tyr)x•xCH3COOH


CAS – 147245-92-9

Copaxone (glatiramer acetate injection) is a treatment for relapsing-remitting multiple sclerosis (RRMS) manufactured by Teva Pharmaceuticals. Sales reached $3.57 billion in 2011.

Teva Pharmaceuticals claims two companies are violating patents on Copaxone, glatiramer acetate for Multiple Sclerosis (MS). The original suit against Momenta Pharmaceuticals and Sandoz now has expanded to include ten patents, three of which run past the expected generic drug entry of 2014…so when generics will appear is now an open question. Copaxone, approved as an orphan drug, is Teva’s flagship product, with sales of over $680 million a year. In addition to being in clinical trials for various combinations, dosage rates, and administration strategies in the mitigation of MS, the drug is now also being studied for macular degeneration and Crohn’s Disease.

Gleevec (imatinib mesylate) is a treatment for chronic myeloid leukemia (CML)and gastrointestinal stromal tumor (GIST). Global sales were $4.26 billion in 2010. Gleevec is manufactured by Novartis.

Gleevec® imatinib 2015-01 exp———Chronic myeloid leukemia, gastrointestinal stromal tumors NOVARTIS

Namenda (memantine HCI) is a treatment for moderate to severe Alzheimer’s disease manufactured by Forest Laboratories, Inc.

Provigil (modafinil), a treatment for excessive sleepiness and shift work sleep disorder, is manufactured by Teva Pharmaceuticals. The product generated $350 million in sales in 2011.

Ipratropium bromide Structural Formula Illustration

C20H30BrNO3•H2O      ipratropium bromide      Mol. Wt. 430.4

Albuterol sulfate Structural Formula Illustration

albuterol sulfate

Combivent (albuterol and ipratropium inhalation) is management of for chronic obstructive pulmonary disease (COPD) symptoms. Boehringer Ingelheim reported sales of $965 million in 2010.

Skeletal formula of linezolid

Zyvox (linezolid) is an antiviral manufactured by Pfizer. The company reported global sales of $325 million in 2011.

Prezista (darunavir) is a protease inhibitor for human immunodeficiency virus (HIV) infection. Distributed by Janssen Therapeutics, Prezista sales were $888 million globally in 2010.


Renagal sevelamer, us dollar 400 in 2008

Avodart (dutasteride) is a treatment for benign prostatic hyperplasia (enlarged prostate gland). GlaxoSmithKline reported sales of $973 million worldwide 2010.


sustiva, efavirenz, US DOLLAR 200 IN 2008

Sustiva is a drug from BMS for the treatment of HIV. When sold along with another drug called Truvada* (which is developed by Gilead, an American biotechnology company) in a fixed-dose combination, the package is called Sustiva franchise. Such fixed dose combinations help simplify HIV therapy for patients and providers. BMS made over $1.5 billion in revenues from this franchise in 2012. The patent for Sustiva ends in 2013 and 2015 for E.U and U.S respectively. However, this is not likely to end the exclusivity for the combination therapy as described above. We expect a gradual decline in the sales of Sustiva as more companies develop generic variants and know how about the variants increases in the market.



(colesevelam hydrochloride) 

Daiichi Sankyo 

Primary Hyperlipidemia; 

Type II Diabetes Mellitus 

$385 million March 2015 





Chemo-Associated Nausea 

& Vomiting; Prevention of 

Post-Op Nausea & Vomiting 

$114 million April 2015 


LOVAZA (omega 3 fatty acids) 


Hypertriglyceridemia $998 million Q1 2015


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YEAR 2016


Adalimumab (HUMIRA, AbbVie) is the third TNF inhibitor, after infliximab and etanercept, to be approved in the United States. Like infliximab and etanercept, adalimumab binds to Tumor necrosis factor-alpha (TNFα), preventing it from activating TNF receptors. Adalimumab was constructed from a fully human monoclonal antibody, while infliximab is a mouse-human chimericantibody and etanercept is a TNF receptor-IgG fusion protein. TNFα inactivation has proven to be important in downregulating theinflammatory reactions associated with autoimmune diseases. As of 2008 adalimumab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of rheumatoid arthritispsoriatic arthritisankylosing spondylitisCrohn’s disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis. Although only approved for ulcerative colitis from late 2012 by the FDA in the disease’s management, it has been used for several years in cases that have not responded to conventional treatment at standard dosing for Crohn’s Disease.

The global autoimmune market is a nearly $25 billion market and includes treatments for rheumatoid arthritis, Crohn’s disease, Addison’s disease, multiple sclerosis, and type I diabetes.

Abbott’s Humira is mainly used to treat rheumatoid arthritis and is the world’s best-selling drug in the autoimmune market with an estimated market share of well over 30%. Humira’s revenues exceeded $8 billion in 2011 and we expect it to top $10 billion by 2013. Abbott mainly competes with Pfizer and Johnson & Johnson in this market.We expect Humira’s market share to gradually decline as competition penetrates the market. However, as evident from the above chart, we expect a steep decline post-U.S. patent expiry in December 2016 (including a year’s extension).




cinacalcet, sensipar amgen

Cinacalcet (INN) is a drug that acts as a calcimimetic (i.e. it mimics the action of calcium on tissues) by allosteric activation of thecalcium-sensing receptor that is expressed in various human organ tissues. It is sold by Amgen under the trade name Sensiparin North America and Australia and as Mimpara in Europe. Cinacalcet is used to treat secondary hyperparathyroidism (elevatedparathyroid hormone levels), a consequence of end-stage renal disease.[1] Cinacalcet is also indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma


Cinacalcet scheme.png

B.C. Van Wagenen, S.T. Moe, M.F. Balandrin, E.G. DelMar, E.F. Nemeth, U.S. Patent 6,211,244 (2001).

CRESTOR (rosuvastatin calcium) Structural Formula Illustration


Crestor (rosuvastatin calcium) by Astra Zeneca, is a treatment for lowering LDL cholesterol I the bloodstream. Crestor sales were $6 billion in 2010.

Benicar (olmesartan medoxomil) for high blood pressure is manufactured by Daiichi Sankyo, Inc. In 2010, sales were $2.5 billion.

Cubicin (daptomycin) is an anti-viral manufactured by Cubist Pharmaceuticals. The drug generated $644 million in global sales in 2010.

Fluticasone Propionate Structural Formula Illustration

fluticasone propionate

Salmeterol Xinafoate Structural Formula Illustration

Salmeterol xinafoate

ADVAIR, fluticasone propionate, Salmeterol xinafoate

GlaxoSmithKline (GSK) may soon face generic competition for Advair, its blockbuster asthma drug.  According to a September 10thWall Street Journal article, the Food and Drug Administration (FDA) has issued draft guidelines for generic versions of Advair (known as Seretide outside the U.S.). Since its FDA approval in 2000, the drug has proven to be a very lucrative product for GSK. As the company’s biggest drug by sales, Advair accounted for about 20% — which translates into $8 billion — of the company’s annual revenues from all markets. The U.S. market represents more than 50% of all Advair sales, by far the largest consumer market for this drug. Based on statistics from IMS Health, Advair sales in the U.S. have risen steadily from $4.4 billion in 2008 to $4.9 billion in 2012.

Advair is delivered by an inhaler designed to treat asthma in patients aged 4 years and older. According to the Centers for Disease Control and Prevention (CDC), the number of adults with asthma in the U.S. in 2011 was 18.9 million—that’s 8.2% of the population. Approximately 7.1 million children under age 18 have asthma, representing 9.5% of their respective population. From 2002-2007, the CDC estimated that the disorder costs $3,300 annually per person in medical expenses. Within the same time period, total national medical costs for asthma increased by 5.6% to $56 billion in 2007 from $53 billion in 2002.

The U.S. patent on Advair’s ingredients expired in 2010 and the patent on its inhaler is set to expire in 2016





YEAR 2017




Atazanavir  marketed under the trade name Reyataz by Bristol Myers, (formerly known as BMS-232632) is an antiretroviral drug of the protease inhibitor (PI) class. Like other antiretrovirals, it is used to treat infection of human immunodeficiency virus (HIV).

Atazanavir is distinguished from other PIs in that it can be given once-daily (rather than requiring multiple doses per day) and has lesser effects on the patient’s lipid profile (the amounts of cholesterol and other fatty substances in the blood). Like other protease inhibitors, it is used only in combination with other HIV medications.

The U.S. Food and Drug Administration (FDA) approved atazanavir on June 20, 2003. Atazanavir is the first PI approved for once-daily dosing, and also appears to be less likely to cause lipodystrophy and elevated cholesterol as side effects. It may also not be cross-resistant with other PIs. When boosted with ritonavir it is equivalent in potency to lopinavir for use in salvage therapy in patients with a degree of drug resistance, although boosting with ritonavir reduces the metabolic advantages of atazanavir.

On October 20, 2006, the FDA approved a new formulation of atazanavir (300 mg capsules) to be taken as part of combination drug therapy. This formulation should reduce pill burden, as one 300 mg capsule may replace two 150 mg capsules.

Reyataz – Reyataz is another drug for the treatment of HIV. BMS develops it under a worldwide license from Novartis and markets it as a combination with Norvir, a drug from Abbott Laboratories. The market exclusivity for the drug ends in U.S., Canada and China in 2017 and in major EU countries and Japan in 2019. The drug accounted for $1.5 billion of BMS’s 2012 revenues.




Eleptripan, relpax USD 625 in 2008

Relpax® eletriptan exp2017-08 Migraines PFIZER IRELAND



Eletriptan Hydrobromide, CAS number 143322-58-1, is a medication indicated for the acute treatment of migraine with or without aura in adults. Known as Relpax, which is marketed by Pfizer, the patent expiration for Eletriptan Hydrobromide is on December 26, 2016 (Patent Use Code U – 876 – TREATMENT OF MIGRAINE WITH OR WITHOUT AURA). Available in 20 milligram and 40 milligram tablets, eletriptan hydrobromide has been shown to be more effectual with the higher dosage of 40 milligrams. Doses of 80 milligrams in trials were deemed efficacious, but led to a greater instance of adverse effects. The maximum recommended dose of eletriptan hydrobromide is 40 milligrams. Common side effects of eletriptan hydrobromide are dizziness, nausea, weakness, drowsiness, and pain or pressure sensations in the chest or throat.




Zetia, ezetimibe USD 1225 in 2008





byetta,exenatide. usd 627 in 2008



lopinavir and ritonavir

Abbott’s Kaletra (generic lopinavir and ritonavir) is an antiviral used to treat HIV and was approved in 2000. It currently has a market share of about 8% in the $18 billion HIV antiviral market. However its market share has been declining due to competition and its exclusion from the list of preferred treatment options in some of the U.S. Department of Health and Human Services’ guidelines. Bristol-Myers’s drug atazanavir (generic reyataz) and Johnson & Johnson’s darunavir (generic prezista) are major competitors in the market.

We expect Kaletra’s market share to continue its gradual decline through 2015, and then drop sharply following its patent expiry in June 2016 to about 2.5% by the end of the Trefis forecast period.



year 2018

Cetuximab (Erbitux) is an epidermal growth factor receptor (EGFR) inhibitor used for the treatment of metastatic colorectal cancer and head and neck cancer. Cetuximab is a chimeric (mouse/human) monoclonal antibody given by intravenous infusion that is manufactured and distributed in the United States by the drug companies Bristol-Myers Squibb and Eli Lilly and Companyand in Europe by the drug company Merck KGaA.

In July 2009, the FDA approved Erbitux for treatment of KRAS wild type colon cancer, since Cetuximab had little or no effect in colorectal tumors harboring a KRAS mutation (this also applied to the EGFR antibody panitumumab)This was the first genetic test to guide treatment of cancer. In July 2012, the FDA approved a real time PCR companion diagnostic test for KRAS, the therascreen KRAS test. Erbitux is a treatment for the cure of colorectal cancer, and head and neck cancer. BMS distributes the drug in partnership with Eli Lilly and reported $702 million in revenues from the sale of this drug. Data exclusivity for this drug ends in 2016 in the U.S., while the patent expires in 2018.

Orlistat (also known as tetrahydrolipstatin) is a drug designed to treat obesity. It is marketed as a prescription under the trade name Xenical by Roche in most countries, and is sold over-the-counter as Alli by GlaxoSmithKline in the United Kingdom and the United States. Its primary function is preventing the absorption of fats from the human diet by acting as alipase inhibitor, thereby reducing caloric intake. It is intended for use in conjunction with a healthcare provider-supervisedreduced-calorie diet

Xenical® Orlistat 2018-01 HOFFMANN LAROCHE

NIZORAL® (Ketoconazole) Structural Formula Illustration


NIZORAL® is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, corn starch, lactose, magnesium stearate, microcrystalline cellulose, and povidone. Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxyl]phenyl] piperazine 


Pf Prism
SOLUTION; ORAL 022488 Jan 4, 2010 RX Yes 6,197,819

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YEAR 2019



Herceptin, the breast cancer drug will face patent expiration in 2014 and 2019 for Europe and US respectively.

With regard to this, many generic manufacturers plan to acquire a significant share of Herceptin’s market. Several companies including Amgen, Pfizer and Novartis have already joined the race to develop a generic version of Herceptin. Similarly, many of the world’s largest selling cancer drugs are scheduled to lose patent protection in the coming years. This will allow the generic manufacturers to replicate and sell the product at cheaper prices.

According to our latest research report “Cancer Generics Market Outlook 2017”, this market for cancer generics is expected to grow at 13%, reaching US$ 19 Billion by 2017. Factors like increasing life expectancy and high incidence of cancer are bound to act as major growth drivers.


Several brands of Fentanyl are nearing patent expiration as well. On April 20, 2018 Lazanda will reach its patent expiration. Abstral has a patent expiration of September 24, 2019 and Fentora will see the end of its patent on March 26, 2019.


Janssen Prods
darunavir ethanolate
TABLET; ORAL 021976 Nov 9, 2012 RX Yes 7,470,506*PED


YEAR 2020


Fenofibrate, CAS number 49562-28-9, is known as the brand name Lipofen, which is marketed by Cipher-Kowa Pharmaceuticals. The patent for Lipofen is due to expire on January 10, 2015. Other recognizable brands of fenofibrate are Tricor, which has a patent expiration of January 9, 2018 and Antara, which has a patent expiration set for August 20, 2020. As an antilipemic agent, fenofibrate is effective at speeding up the natural processes in the body that remove cholesterol.


Tadalafil skeletal.svg

Tadalafil is a PDE5 inhibitor marketed in pill form for treatingerectile dysfunction(ED)
under the name Cialis, and under the name Adcirca for the treatment of pulmonary arterial hypertension
Cialis’ patents are set to expire between 2017 and 2020. Viagra’s patent was originally scheduled to expire in late March of 2012 but was extended to April 2020.

NEXAVAR (sorafenib tosylate – tablet; oral)

  • Manufacturer: BAYER HEALTHCARE
    Approval date: December 20, 2005
    Strength(s): EQ 200MG BASE 
  • Omega-carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
    Patent 7,235,576
    Issued: June 26, 2007
    Inventor(s): Riedl; Bernd & Dumas; Jacques & Khire; Uday & Lowinger; Timothy B. & Scott; William J. & Smith; Roger A. & Wood; Jill E. & Monahan; Mary-Katherine & Natero; Reina & Renick; Joel & Sibley; Robert N.
    Assignee(s): Bayer Pharmaceuticals Corporation
    This invention relates to the use of a group of aryl ureas in treating raf mediated diseases, and pharmaceutical compositions for use in such therapy.

    Patent expiration dates:
    • January 12, 2020
      Drug substance
      Drug product
  • ω-Carboxyaryl substituted diphenyl ureas as raf kinase inhibitors
    Patent 7,351,834
    Issued: April 1, 2008
    Inventor(s): Riedl; Bernd & Dumas; Jacques & Khire; Uday & Lowinger; Timothy & Scott; William & Smith; Roger A. & Wood; Jill E. & Monahan; Mary-Katherine & Natero; Reina & Renick; Joel & Sibley; Robert
    Assignee(s): Bayer Pharmaceuticals Corporation
    This invention relates to the use of a group of aryl ureas in treating raf mediated diseases, and pharmaceutical compositions for use in such therapy.

    Patent expiration dates:
    • January 12, 2020
      Drug substance
  • ω-carboxyl aryl substituted diphenyl ureas as p38 kinase inhibitors
    Patent 7,897,623
    Issued: March 1, 2011
    Inventor(s): Riedl; Bernd & Dumas; Jacques & Khire; Uday R. & Lowinger; Timothy B. & Scott; William J. & Smith; Roger A. & Wood; Jill E. & Monahan; Mary-Katherine & Natero; Reina & Renick; Joel & Sibley; Robert N.
    Assignee(s): Bayer Healthcare LLC
    This invention relates to the use of a group of aryl ureas in treating p38 mediated diseases, and pharmaceutical compositions for use in such therapy.

    Patent expiration dates:
    • January 12, 2020
      Drug product

Sanofi Aventis Us
fexofenadine hydrochloride; pseudoephedrine hydrochloride
Kowa Co
pitavastatin calcium
Cppi Cv
sunitinib malate
The preview shows a limited data set. Complete access is available with a Subscription




International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 7, Issue 2, 2015

link………US pharmacist. De Ruiter J, L Holston. A Jobson publication [Internet]. No date. Cited 2014 September 10; Available from: URL: 35249/

Additional info

Patent expirations up to 2016 will reduce brand spending in worldwide developed markets by $127 billion, but will be counterbalanced by generic spending, resulting in a five-year global savings of close to $106 billion. In Japan, the UK, France and Germany, many of the same or similar brands that were impacted in the U.S. will also lose patent protection. For example, in Japan, the use of generics is expected to increase as the government promotes policies to use lower-cost alternatives, and major products face generic competition. Overall, exclusivity loss in one or more developed markets will impact seven of the top 10 leading prescription drugs, including Lipitor, Plavix, Advair Diskus, Crestor, and Nexium.

Source: IMS Institute for Healthcare Informatics. The Global Use of Medicines: Outlook Through 2016. July 2012.

Protection Expiry Year US Japan UK France Germany
2012 Plavix®Seroquel®Singulair®Actos®Lexapro®Diovan®Diovan HCT®Geodon®Viagra®Boniva® Nu LotanMyslee®Preminent HaigouSeroquel® Lipitor®AmiasSeroquel®Aricept®Singulair® TahorSingulair®Pariet®IxprimAprovel Seroquel®Atacand®Atacand® PlusSortis®Aricept®
2013 Oxycontin®Aciphex®Zometa®Xeloda®Opana®ERAsacol® Diovan®Plavix®Livalo®Elplat® Viagra®Xeloda® Seretide®CoaprovelXeloda®Micardis®Viagra® Viani®Zometa®Atmadisc®CoaprovelViagra®
2014 Nexium®Cymbalta®Celebrex®Symbicort®Lunesta®Restasis®Evista®Sandostatin® LARActonel® Prograf®Glivec®Abilify® Abilify®Cipralex®Risperdal® Consta® Seroplex®Abilify®Ebixa®Risperdal® Consta® LP AxuraRisperdal® Consta®Blopress Plus®
2015 Abilify®Copaxone®Gleevec®Namenda®Provigil®Combivent®Zyvox®Prezista®Avodart® Zyprexa®Adoair®Alimta®Spiriva®Symbicort® Spiriva®Cymbalta®Alimta® Alimta®Spiriva®Copaxone®Protelos®Cymbalta® Spiriva®Copaxone®Alimta®Cymbalta®
2016 Crestor®Benicar®Benicar HCT®Cubicin® BlopressBaraclude® Glivec®Vfend® Glivec®Cancidas®Vfend® Glivec®ZyvoxidVfend®




Off Going Patents 2013-2016

Drug Disease Company Time of Expiry
Rizatriptan Migraine Merck Jan., 2013
Ertapenem Antibiotic Merck Feb, 2013
Caspofungi Antibiotic Merck March, 2013
Rituximab Biopharm Gentech March, 2013
Tegaserod Gastro Novartis April, 2013
Imatinib Mesylate Oncology Novartis May, 2013
Insulin Lispro Diabetes Eli Lilly May, 2013
Decliximab Biopharm Protein Design June, 2013
Teriparatide Hormone Eli Lilly July, 2013
Erytropoietin Biopharm Amgen Aug, 2013
Eletriptan Migraine Merck Aug. 2013
Insulin Aspart Diabetes Novo Sept, 1013
Voriconazole Antibiotic Pfizer Oct, 2013
Almotriptan Migraine Pharmacia Oct, 2013
Montelukast Respiratory Merck Oct, 2013
Risedronate Sodium Hormone P & G Dec, 2013
Palvizumab Biopharm Medi Immune Dec., 2013
Grepafloxacin Antibiotic Glaxo Dec, 2013
Telmistran C.V. Jan, 2014
Insulin Glargin Diabetes Aventis April, 2014
Esomeprazole Gastro A.Z. May, 2014
Posaconazole Antibiotic Shering Aug, 2014
Transtuzumab Biopharm Gentech Oct, 2014
Linezolid Antibiotic Pharmacia Nov, 2014
Colesevelam C.V. Geltek Dec, 2014
Idiotypic CEA Oncology Titan Dec, 2014
Omalizumb Respiratory Roche Feb, 2015
Telethromycin Antibiotic Aventis April, 2015
Gemifloxacin Antibiotic GSK June, 2015
Omaptrilar C.V. B.M. June, 2015
Abciximab Biopharm Gentocore June, 2015
Alemtuzumb Oncology Millennium Dec, 2015
Pitavastatin C.V. Nissan Jan, 2016




Drug patent expirations 2012–2015

From now until 2015, at least 13 blockbuster drugs are scheduled to lose their patent protection. Health plans and PBMs can use Lipitor’s patent expiration to fine tune their plans for other upcoming conversions.

*Some of these totals differ from the sum of the columns because of rounding.
Source: IMS Health and T. Reinke

mAb (target) Companies Global 2011 sales (US$ billions)* Expiry of constraining product patent*
United States European Union
Infliximab (TNF) Johnson & Johnson; Merck & Co.; Mitsubishi Tanabe $9.0 Sep 2018 Aug 2014
Adalimumab (TNF) Abbott; Eisai $8.2 Mar 2019 Apr 2018
Etanercept (TNF) Amgen; Pfizer; Takeda $7.9 Nov 2028 Feb 2015
Rituximab (CD20) Roche $6.8 Dec 2015 Nov 2013
Bevacizumab (VEGF) Roche $6.0 Jul 2019 Apr 2018
Trastuzumab (HER2) Roche $5.9 Nov 2023 Jul 2014
Ranibizumab (VEGF) Novartis; Roche $3.8 Jul 2019 Apr 2018§
Cetuximab (EGFR) Bristol-Myers Squibb; Merck Serono $1.9 Jun 2015 Sep 2014
Natalizumab (α4 integrin) Biogen Idec $1.5 Mar 2015 Aug 2015§
Omalizumab (IgE) Novartis; Roche $1.2 Jan 2020 Aug 2017
*Estimated patent expiry dates and 2011 sales data provided by Thomson Reuters. The main patent on etanercept had been expected to expire in October 2012, but Amgen recently secured an additional 17 years of protection owing to a filing loophole. §Supplementary protection certificates have been filed for these products in some European Union member states, potentially adding up to an additional 5 years of protection. EGFR, epidermal growth factor receptor; IgE, immunoglobulin E; mAb, monoclonal antibody; TNF, tumour necrosis factor; VEGF, vascular endothelial growth factor.

Patent Expiring Drugs
Brand name , Year ofexpiring, INN,  COMPANY NAME
Remicade 2014 Infliximab J&J
Humira 2016 adalimumab Abbott
Avastin 2018 bevacizumab Roche
Mab/reditux 2015 Rituximab Roche/biogenidec
Hereceptin 2015 Trastuzumab Roche
Enbrel 2012 Etanercept Amgen/Pfizer
Orencia 2019 abatacept Bms
Aranesep 2016 darbepoetinalfa Amgen
Neulasta 2017 pegpelgrastrim Amgen
Rituxan 2013 rituximab Genentec




P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent.

P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent.

P.S. : The views expressed are my personal and in no-way suggest the views of the professional body or the company that I represent.


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  4. […] PATENT EXPIRY DATES « New Drug Approvals – The global generic pharmaceuticals market is likely to witness strong growth in the next few years owing to the patent expiration of key blockbuster drugs and the …… […]

  5. Tanju Kaptan says:

    Please add me to your distribution list, thanks!

  6. pradyot biswas says:

    great site. would be more better if a comprehensive list is available first followed by illustrative list. as a preface it is necessary to inform why this beautiful site was prepared and who may be benefited from it.

  7. Suresh Dave says:

    Very knowledgeable site for aspiring pharma entrepreneur Especially , one can make good money by introducing first generic brand whose patent is about to expired , mainly in African countries

  8. MPL says:

    Pls do include me in your mailing list as well as updates on Product expirations.

  9. Can you advise api molecules going off patent from 2021 to 2024

  10. DonaldTamp says:

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  11. Kelly says:

    Please add me to your mailing list re updates on Product expirations.

  12. Azeez M Mubarak says:

    Please add me to your distribution list. Great contribution to the Pharma industry


  13. Tim Tiemann says:

    Please add me to your distribution



    Dear Dr. Crasto,

    So much information on pharmaceuticals. Relevant and specific. I got what I wanted on your blog. Thank you for updating and making it simpler for all.

  16. Ashok Anand says:

    Can I get list of molecules going off patent from year 2020 to 2025 preferably with Innovator name and current worldwide sales.

  17. sjwilliamspa says:

    Thanks Dr.Crasto,,thisi s an invaluable resource you posted here in curating the present and future patent expirations.

  18. sjwilliamspa says:

    Great new update Dr. Crasto. Humira expiration will be big this year but unbelievable its time is up already.

  19. Dear & Respected Dr.Anthony Crasto,
    I am very much pleased to collect all the information what I needed instead of searching here and there. I hope this site is very useful for the development of generics in India.

  20. Arun Mandal says:

    Great update Dr Castro and very useful. Kindly add me in your mailing list for future updates. t

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  23. Balachandar says:

    Very good information, TQ

  24. DR.RAKESH SAHAY says:


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DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with AFRICURE PHARMA, ROW2TECH, NIPER-G, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Govt. of India as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 32 PLUS year tenure till date Feb 2023, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 38 lakh plus views on New Drug Approvals Blog in 227 countries...... , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc He has total of 32 International and Indian awards

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