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Clopidogrel bisulfate - Generic Drug Details
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What are the generic 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, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Cadila, Celltrion, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Graviti Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, and Sanofi Aventis Us, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.There are fifty-four drug master file entries for clopidogrel bisulfate. Forty-two suppliers are listed for this compound.
Summary for clopidogrel bisulfate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 21 |
| NDAs: | 22 |
| Drug Master File Entries: | 54 |
| Suppliers / Packagers: | 42 |
| Bulk Api Vendors: | 168 |
| Clinical Trials: | 16 |
| Patent Applications: | 4,000 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for clopidogrel bisulfate |
| Drug Sales Revenues: | Drug sales revenues for clopidogrel bisulfate |
| 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Celltrion | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 202266-001 | Aug 14, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Dr Reddys Labs Ltd | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 091023-001 | May 17, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Aurobindo Pharma Ltd | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 090540-001 | May 17, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Ani Pharms Inc | CLOPIDOGREL BISULFATE | clopidogrel bisulfate | TABLET;ORAL | 090625-001 | May 17, 2012 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >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 | 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 | 020839-001 | Nov 17, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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