CLOPIDOGREL BISULFATE Drug Patent Profile
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Which patents cover Clopidogrel Bisulfate, and what generic alternatives are available?
Clopidogrel Bisulfate is a drug marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Alkem Labs Ltd, Amneal Pharms, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Polygen Pharms, Prinston Inc, Rising, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, and Zydus Lifesciences. and is included in twenty-four NDAs.
The generic ingredient in CLOPIDOGREL BISULFATE is clopidogrel bisulfate. There are fifty-four drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Clopidogrel Bisulfate
A generic version of CLOPIDOGREL BISULFATE was approved as clopidogrel bisulfate by DR REDDYS on January 14th, 2008.
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Summary for CLOPIDOGREL BISULFATE
See drug prices for CLOPIDOGREL BISULFATE
Recent Clinical Trials for CLOPIDOGREL BISULFATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Joint Stock Company "Farmak" | Phase 1 |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | N/A |
| Nanjing First Hospital, Nanjing Medical University | Phase 4 |
Pharmacology for CLOPIDOGREL BISULFATE
| Drug Class | P2Y12 Platelet Inhibitor |
| Mechanism of Action | Cytochrome P450 2C8 Inhibitors P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Anatomical Therapeutic Chemical (ATC) Classes for CLOPIDOGREL BISULFATE
Paragraph IV (Patent) Challenges for CLOPIDOGREL BISULFATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| PLAVIX | Tablets | clopidogrel bisulfate | 300 mg | 020839 | 1 | 2009-03-04 |
US Patents and Regulatory Information for CLOPIDOGREL BISULFATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Torrent Pharms Ltd | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 090844-001 | May 17, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sciegen Pharms Inc | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 204165-002 | Sep 15, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Zydus Lifesciences | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 201686-001 | Oct 10, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sun Pharm | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 090494-001 | May 17, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
