CLOPIDOGREL BISULFATE - Generic Drug Details
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What are the generic drug sources for clopidogrel bisulfate and what is the scope of freedom to operate?
Clopidogrel bisulfate
is the generic ingredient in two branded drugs 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, MSN, Polygen Pharms, Prinston Inc, Rising, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, Zydus Lifesciences, and Sanofi Aventis Us, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.There are forty-five drug master file entries for clopidogrel bisulfate. Forty-three suppliers are listed for this compound.
Summary for CLOPIDOGREL BISULFATE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 24 |
NDAs: | 26 |
Drug Master File Entries: | 45 |
Finished Product Suppliers / Packagers: | 43 |
Raw Ingredient (Bulk) Api Vendors: | 126 |
Clinical Trials: | 19 |
Patent Applications: | 7,388 |
Drug Prices: | Drug price trends for CLOPIDOGREL BISULFATE |
Drug Sales Revenues: | Drug sales revenues for CLOPIDOGREL BISULFATE |
What excipients (inactive ingredients) are in CLOPIDOGREL BISULFATE? | CLOPIDOGREL BISULFATE excipients list |
DailyMed Link: | CLOPIDOGREL BISULFATE at DailyMed |
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 |
The First Affiliated Hospital with 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd V | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 205345-001 | Aug 4, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amneal Pharms | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 203751-001 | Apr 11, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rising | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 204359-001 | Feb 2, 2017 | AB | RX | 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 |
Expired US Patents for CLOPIDOGREL BISULFATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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