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DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO
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ACIPHEX, RABEPRAZOLE SODIUM, patent exp 8 th Nov 2013
AS SODIUM SALT
Bottle of rabeprazole 20 mg tablets
ACIPHEX, RABEPRAZOLE SODIUM
Drug Patent Expiration and Exclusivity
US 5045552 – Uspto – United States Patent and Trademark Office
| Active Ingredient | Form | Dosage | Drug Type | Application | Product | |
|---|---|---|---|---|---|---|
| RABEPRAZOLE SODIUM | TABLET, DELAYED RELEASE; ORAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | DISCN | 020973 | 001 | |
| RABEPRAZOLE SODIUM | TABLET, DELAYED RELEASE; ORAL | 20MG | RX | 020973 | 002 |
EISAI INC’s ACIPHEX.
| Patent | Expiration | |
|---|---|---|
| US 5045552*PED | 2013-11-8 | |
| US 5045552 | Pyridine derivatives having anti-ulcerative activity
Pyridine derivatives useful for preventing or treating peptic ulcers, pharmaceutical preparations and methods of treating peptic ulcers are described.
|
2013-5-8(expired) |
Exclusivity
Exclusivity is marketing rights granted by the FDA to the EISAI INC.
KAPVAY, CLONIDINE HYDROCHLORIDE, Patent expiry…13 th oct 2013
CLONIDINE
C9H9Cl2N3•HCl Mol. Wt. 266.56
Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the structural formula:
Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and alcohol.
KAPVAY
SHIONOGI INC
Drug Patent Expiration and Exclusivity
Drug Information
| Active Ingredient | Form | Dosage | Drug Type | Application | Product | |
|---|---|---|---|---|---|---|
| CLONIDINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 0.1MG | RX | 022331 | 003 | |
| CLONIDINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE; ORAL | 0.2MG | RX | 022331 | 004 |
Patents
There are 1 patent(s) protecting SHIONOGI INC’s KAPVAY.
The last patent expires on 2013-10-13.
| Patent | Expiration | |
|---|---|---|
| US5869100 | Extended release clonidine formulation (tablet)
A method of providing a patient needing clonidine with an extended dosage of clonidine over a prolonged period of time. Such method involves administering to the patient an oral dosage unit comprising a homogenous mixture of a therapeutically effective amount of clonidine, about 30 to about 70 percent by weight of one or more cellulose ethers such as hydroxypropyl methylcellulose, and about 30 to about 70 percent by weight of an inert substance such as cornstarch. The oral dosage unit may be contained in a gelatin capsule or in the form of a tablet.
|
2013-10-13(expired) |
Exclusivity
Exclusivity is marketing rights granted by the FDA to the SHIONOGI INC.
Exclusivity ends on 2013-09-28.
loteprednol etabonate…Patent expiry this week……of October 20, 2013
loteprednol etabonate
82034-46-6 cas
Drug Patent Expiry for the week of October 20, 2013
Tradename….LOTEMAX
Applicant………Pharmos
SUSPENSION/DROPS; OPHTHALMIC, o.5%
Generic Name………loteprednol etabonate
Patent No.US 5,540,930
http://www.google.co.in/patents/US5540930
The invention provides novel compositions of matter containing water-insoluble steroid drugs suitable for therapeutic use. The invention provides stable aqueous suspensions of water-insoluble steroid drugs of particle sizes of ≦15 μm which remain in such a state so as to allow for immediate suspension, when desired, even after extended periods of settling.
| Date | Supplement No. | Action | Documents |
|---|---|---|---|
| 1998-03-09 | 000 | Approval |
| Publication number | US5540930 A |
| Publication type | Grant |
| Application number | US 08/142,743 |
| Publication date | 30 Jul 1996 |
| Filing date | 25 Oct 1993 |
| Priority date | 25 Oct 1993 |
| Fee status | Paid |
| Also published as | CA2174550A1, CA2174550C, DE69430635D1, DE69430635T2, EP0730443A1, EP0730443A4, EP0730443B1, US5747061, WO1995011669A1, Less «8 More » |
| Publication number | 08142743, 142743, US 5540930 A, US 5540930A, US-A-5540930, US5540930 A, US5540930A |
| Inventors | Doron I. Friedman, Yaacov J. Guy |
| Original Assignee | Pharmos Corporation |
| Company | |||
|---|---|---|---|
| LOTEMAX NDA (020583) | BAUSCH AND LOMB | LOTEPREDNOL ETABONATE | |
| ALREX NDA (020803) | BAUSCH AND LOMB | LOTEPREDNOL ETABONATE | |
| LOTEMAX NDA (020841) | PHARMOS | LOTEPREDNOL ETABONATE…expired | |
| ZYLET NDA (050804) | BAUSCH AND LOMB | LOTEPREDNOL ETABONATE; TOBRAMYCIN | |
| LOTEMAX NDA (200738) | BAUSCH AND LOMB | LOTEPREDNOL ETABONATE | |
| LOTEMAX NDA (202872) | BAUSCH AND LOMB | LOTEPREDNOL ETABONATE |
Loteprednol (as the ester loteprednol etabonate) is a corticosteroid used in optometry and ophthalmology. Marketed by Bausch and Lomb as Lotemax in the U.S., ocular applications for this drug include the treatment of inflammation of the eye due to allergies (according to the prescription information sheet), as well as chronic forms of keratitis (e.g.: adenoviral and Thygeson’s keratitis), vernal keratoconjunctivitis, pingueculitis, and episcleritis. The drug has little or no effect on intraocular pressure.
Druzgala, P.; Hochhaus, G.; Bodor, N.; J. Steroid Biochem. Mol. Biol. 1991, 38, 149.
http://dx.doi.org/10.1016/0960-0760(91)90120-T
- Steward, R; et al. (November 1998). “Double-masked, placebo-controlled evaluation of loteprednol etabonate 0.5% for postoperative inflammation”. J Cataract Surg 24: 1480–1489.
- Pavesio, CE; Decory, HH (2008). “Treatment of ocular inflammatory conditions with loteprednol etabonate”. Br J Ophthalmol 92 (4): 455–459. doi:10.1136/bjo.2007.132621. PMID 18245274.
How Long Is A Drug Patent Good For?
Patents are good for 20 years after the invention of a drug–not after the drug comes to market. It can easily take eight years for the pharmaceutical companies to gather enough data to get approval for their new invention from the U.S. Food and Drug Administration. Meanwhile the FDA can send the drug company back for more clinical studies (experiments using humans as subjects to test the drugs’ efficacy and side effects) and more data, and all the while the patent clock is ticking.
That’s why the name of the game for pharmaceutical companies is working to extend those patents for a top-selling drug
read all at
How Long Is A Drug Patent Good For? – Drugsdb.com http://www.drugsdb.com/blog/how-long-is-a-drug-patent-good-for.html#ixzz2evb9L5rn
The Claimed Intermediate database by Tcipatent Ltd
Eddie Kehoe
Principal & Technical Director at Tcipatent Ltd
Hove, Brighton and Hove, United KingdomPharmaceuticalsThe Claimed Intermediate – a Structure Searchable Process Patent Database for Marketed Pharmaceutical Drugs (INNs).
Patent examining, searching, analysis and abstracting especially in the Chemical subject area.
The Claimed Intermediate is an online database
which covers Process Patents for Named Marketed Pharmaceutical Drugs – whether intermediates are claimed or not – for a low-cost subscription.
- Structure Searchable
- Includes INNs in at least one major Market
- Includes Drug Synthesis often buried in a Plethora of Patents
- Informs Pipeline decisions
- Provides targeted Patent data in a Visual form
- Informs Commercial Synthesis profitability
shared message from Eddie Kehoe
If anybody would like a trial of the database they could contact either myself eddie.kehoe@tcipatent.com, or my wife and fellow director, Pat Kehoe (pat.kehoe@tcipatent.com).
Here are temporary logons , please request trial
(deactivated automatically in five working days):
Link: Link: www.tcipatent.com/tcidb/
Structure Searchable Patent Database for Processes covering Named Marketed Pharmaceutical Drugs (INNs). The database is an ongoing Watching Service combined with a Backward Drug Service.
Eddie Kehoe
Principal & Technical Director
Tcipatent Ltd
www.tcipatent.com
info@tcipatent.om
tcipatent.com
Office: +44 (0)1273 736080
43 Farm Road, Hove, BN3 1FD, United Kingdom
Eddie Kehoe:
eddie.kehoe@tcipatent.com
Mobile – 07425629637
Skype – eddieskihoe
TWITTER-TCIPATENT
Pat Kehoe:
pat.kehoe@tcipatent.com
Mobile – 07585295531
Skype – patkehoe170348
Database Updates:
Recently Added Records
| Aliskiren | Ambrisentan |
| Asenapine | Atorvastatin |
| Bosentan | Cabazitaxel |
| Cefamandole | Dasatinib |
| Desogestrel | Dexmedetomidine |
| Docetaxel | Doripenem |
| Doxapram | Duloxetine |
| Etonogestrel | Etoricoxib |
| Etravirine | Fluvastatin |
| Gefitinib | Iodixanol |
| Iohexol | Iopamidol |
| Linagliptin | Mitiglinide |
| Montelukast | Moxonidine |
| Oseltamivir | Paclitaxel |
| Perampanel | Pitavastatin |
| Pravastatin | Praziquantel |
| Ritodrine | Rosuvastatin |
| Silodosin | Sitagliptin |
| Ticagrelor | Ulipristal |
| Zidovudine |
………..
photo
Coopers Cask – Pub in Hove BN3 1FB
Eddie is closeby
CSIR, INDIA-WO PATENT–synthesis of amprenavir and saquinavir
amprenavir
saquinavir
A process for synthesis of syn azido epoxide and its use as intermediate in the synthesis of amprenavir and saquinavir
Published as ———WO-2013105118
Council of Scientific & Industrial Research
Inventors
Gadakh, Sunita, Khanderao; Rekula, Reddy, Santhosh; Sudalai, Arumugam
Publication date 18-JUL-2013
HIV protease inhibitor
Disclosed herein is a novel route of synthesis of syn azide epoxide of formu 5, which is used as a common intermdeiate for asymmetric synthesis of HIV protease inhibitors such as Amprenavir, Fosamprenavir, Saquinavir and formal synthesis of Darunavir and Palinavir obtained by Cobalt- catalyzed hydrolyti kinetic resolution of racemic anti-(2SR, 3SR) – 3 -azido – 4 -phenyl – 1, 2- epoxybutane (azido-epoxide
| IN2012DE82 | 10-JAN-2012 [priority] |
Patent of Fresenius Kabi Oncology Ltd.Novel intermediates and process for the preparation of lapatinib and…….
LAPATINIB
Lapatinib (INN), used in the form of lapatinib ditosylate, (USAN) (Tykerb/Tyverb, GSK) is an orally active drug for breast cancer and other solid tumours. It is a dual tyrosine kinase inhibitor which interrupts the HER2/neu and epidermal growth factor receptor (EGFR) pathways. It is used in combination therapy for HER2-positive breast cancer. It is used for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 (ErbB2).
………………………………………………………..
Beilstein J. Org. Chem. 2013, 9, 2265–2319.
http://www.beilstein-journals.org/bjoc/single/articleFullText.htm?publicId=1860-5397-9-265
GlaxoSmithKline’s lapatinib (3.38, Tykerb) is a novel dual kinase inhibitor used in the treatment of solid tumors such as those found in breast cancer and contains a quinazoline core structure. It consists of a 2,5-disubstituted furan ring, which is directly linked to the aminoquinazoline unit (Scheme 41). The quinazoline heterocycle was prepared starting from 5-iodoanthranilic acid (3.72) via initial condensation with formamidine acetate (3.73) followed by chlorination using oxalyl chloride or phosphorous oxychloride [101]. Performing a nucleophilic aromatic substitution on the chloride 3.74 with aniline 3.75 renders the extended core of lapatinib. This intermediate (3.76) was then coupled with 5-formyl-2-furanoboronic acid (3.77) using standard Suzuki cross-coupling conditions. Finally, a reductive amination of the pendant aldehyde of 3.78 with 2-(methylsulfonyl)ethylamine (3.79) furnishes the desired product lapatinib (Scheme 41).
![[1860-5397-9-265-i41]](http://www.beilstein-journals.org/bjoc/content/inline/1860-5397-9-265-i41.png?scale=2.0&max-width=1024&background=FFFFFF)
http://www.beilstein-journals.org/bjoc/single/articleFullText.htm?publicId=1860-5397-9-265
……………………………………………..
Fresenius Kabi Oncology Ltd.WO 2013080218
Lahiri, Saswata; Gupta, Nitin; Singh, Hemant Kumar; Handa, Vishal; Sanghani, Sunil
6 JUNE 2013, http://www.google.com/patents/WO2013080218A1?cl=en
Literature References: Reversible dual inhibitor of ErbB1 and ErbB2 tyrosine kinases. Prepn: M. C. Carter et al., WO 9935146(1999 to Glaxo); eidem, US 6727256 (2004 to SmithKline Beecham). Mechanism of action study: W. Xia et al., Oncogene 21, 6255 (2002); and crystal structure in complex with epidermal growth factor receptor (EGFR, ErbB1): E. R. Wood et al., Cancer Res. 64, 6652 (2004). In vitro antitumor activity in combination with anti-ErbB2 antibodies: W. Xia et al., Oncogene 24, 6213 (2005). Biologic effects on tumor growth: N. L. Spector et al., J. Clin. Oncol. 23, 2502 (2005). Pharmacokinetics and clinical activity in metastatic carcinomas: H. A. Burris III et al., ibid. 5305. Review of clinical development: T. E. Kim, J. R. Murren, IDrugs6, 886-893 (2003); H. A. Burris III, Oncologist 9, Suppl. 3, 10-15 (2004).
PROCESS FOR MANUFACTURE OF TELMISARTAN PATENT US2013137878 (A1)30 MAY 2013
A process for preparing telmisartan by reacting 2-n-propyl-4-methyl-6-(1′-methylbenzimidazol-2′-yl)benzimidazole with a compound of formula (IV) wherein Z is a leaving group, to obtain the compound 2-cyano-4′-[2”-n-propyl-4”-methyl-6”-(1”’-methylbenzimidazol-2”’-yl)benzimidazol-1”-ylmethyl]biphenyl, and subsequently hydrolyzing the nitrile function to obtain the acid function.
New Drug Approvals 