PLAVIX Drug Patent Profile
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When do Plavix patents expire, and when can generic versions of Plavix launch?
Plavix is a drug marketed by Sanofi Aventis Us and is included in one NDA.
The generic ingredient in PLAVIX is clopidogrel bisulfate. There are fifty-four drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Plavix
A generic version of PLAVIX was approved as clopidogrel bisulfate by DR REDDYS on January 14th, 2008.
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Questions you can ask:
- What is the 5 year forecast for PLAVIX?
- What are the global sales for PLAVIX?
- What is Average Wholesale Price for PLAVIX?
Summary for PLAVIX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 126 |
| Clinical Trials: | 220 |
| Patent Applications: | 3,989 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for PLAVIX |
| Drug Sales Revenues: | Drug sales revenues for PLAVIX |
| What excipients (inactive ingredients) are in PLAVIX? | PLAVIX excipients list |
| DailyMed Link: | PLAVIX at DailyMed |
Recent Clinical Trials for PLAVIX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lady Reading Hospital, Pakistan | Phase 3 |
| Pakistan Chest Society, Pakistan | Phase 3 |
| Mercy Health Ohio | Phase 3 |
Pharmacology for PLAVIX
| Drug Class | P2Y12 Platelet Inhibitor |
| Mechanism of Action | Cytochrome P450 2C8 Inhibitors P2Y12 Receptor Antagonists |
| Physiological Effect | Decreased Platelet Aggregation |
Paragraph IV (Patent) Challenges for PLAVIX
| 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 PLAVIX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | AB | RX | Yes | 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 PLAVIX
| 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 | ⤷ 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 |
| Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PLAVIX
See the table below for patents covering PLAVIX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 4048399 | ⤷ Sign Up | |
| Yugoslavia | 197485 | ⤷ Sign Up | |
| Australia | 1663783 | ⤷ Sign Up | |
| Japan | S5927895 | NOVEL THIENO(3,2-C)PYRIDINE DERIVATIVE, MANUFACTURE AND THERAPY | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PLAVIX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0281459 | 9890035-0 98910359 | Sweden | ⤷ Sign Up | PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715 |
| 0281459 | 098C0045 | Belgium | ⤷ Sign Up | PRODUCT NAME: CLOPIDOGREL; REGISTRATION NO/DATE: EU/1/98/069/001 19980715 |
| 0281459 | SPC/GB99/001 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: CLOPIDOGREL HYDROGEN SULPHATE, THE DEXTROROTATORY ISOMER OF ALPHA-(4,5,6,7-TETRAHYDROTHIENO(3,2-C)PYRID-5-YL)(2-CHLOROPHENYL) METHYL ACETATE AS THE HYDROGEN SULPHATE SALT; REGISTERED: UK EU/1/98/069/001 19980715; UK EU/1/98/069/002 19980715; UK EU/1/98/069/003 19980715 |
| 0281459 | 35/1998 | Austria | ⤷ Sign Up | PRODUCT NAME: CLOPIDOGREL-HYDROGENSULFAT; REGISTRATION NO/DATE: EU/1/98/069/001 - EU/1/98/069/003 19980715 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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