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Clopidogrel bisulfate - Generic Drug Details
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What are the generic drug sources for clopidogrel bisulfate and what is the scope of patent protection?
Clopidogrel bisulfate
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Adaptis, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Cadila, Celltrion, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Polygen Pharms, Prinston Inc, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, and Sanofi Aventis Us, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.There are fifty-four 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: | 22 |
NDAs: | 23 |
Drug Master File Entries: | 54 |
Suppliers / Packagers: | 43 |
Bulk Api Vendors: | 109 |
Clinical Trials: | 16 |
Patent Applications: | 4,152 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | N/A |
The First Affiliated Hospital with Nanjing Medical University | Phase 4 |
CKD Pharmaceutical Limited | Phase 4 |
Pharmacology for clopidogrel bisulfate
Drug Class | P2Y12 Platelet Inhibitor |
Mechanism of Action | P2Y12 Receptor Antagonists Cytochrome P450 2C8 Inhibitors |
Physiological Effect | Decreased Platelet Aggregation |
Paragraph IV (Patent) Challenges for CLOPIDOGREL BISULFATE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
PLAVIX | TABLET;ORAL | clopidogrel bisulfate | 020839 | 2009-03-04 |
US Patents and Regulatory Information for clopidogrel bisulfate
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 | 020839-001 | Nov 17, 1997 | Start Trial | Start Trial |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | Start Trial | Start Trial |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | Start Trial | Start Trial |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | Start Trial | Start Trial |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | Start Trial | Start Trial |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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