PLAVIX Drug Patent Profile
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Which patents cover Plavix, 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.
Summary for PLAVIX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 126 |
Clinical Trials: | 219 |
Patent Applications: | 4,755 |
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 |
---|---|
Mercy Health Ohio | Phase 3 |
Sarmad Zahoor | Phase 4 |
University of Managemant and Technology, Pakistan | Phase 4 |
Pharmacology for PLAVIX
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 PLAVIX
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 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 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-001 | Nov 17, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | PLAVIX | clopidogrel bisulfate | TABLET;ORAL | 020839-002 | Sep 20, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Japan | S5927895 | NOVEL THIENO(3,2-C)PYRIDINE DERIVATIVE, MANUFACTURE AND THERAPY | ⤷ Try a Trial |
Finland | 880720 | ⤷ Try a Trial | |
Argentina | 014854 | POLIMORFO CRISTALINO DEL HIDROGENOSULFATO DE CLOPIDROGREL (FORMA2) (+)-(S)-ALFA-(2-CLOROFENIL)-4,5,6,7-TETRAHIDROTIENO[3,2-C]PIRIDINIL-5-ACETATO DE METILO ,PROCEDIMIENTO PARA SU PREPARACIoN Y COMPOSICIoN FARMACÉUTICA QUE LO CONTIENE | ⤷ Try a Trial |
South Africa | 200006386 | ⤷ Try a Trial | |
Bulgaria | 104987 | ⤷ Try a Trial | |
Croatia | P20000863 | POLYMORPHIC CLOPIDOGREL HYDROGENESULPHATE FORM | ⤷ Try a Trial |
>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 | ⤷ Try a Trial | PRODUCT NAME: PLAVIX-CLOPIDOGREL; REG. NO/DATE: EU/1/98/069/001 19980715 |
0281459 | 98C0036 | France | ⤷ Try a Trial | PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001 |
0281459 | SPC/GB99/001 | United Kingdom | ⤷ Try a Trial | 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 |
0302769 | 98C0036 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001 |
0281459 | C990002 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: CLOPIDOGREL WATERSTOFSULFAAT; REGISTRATION NO/DATE: EU 1/98/069/001 - EU 1/98/069/003 19980715 |
0281459 | 098C0045 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CLOPIDOGREL; REGISTRATION NO/DATE: EU/1/98/069/001 19980715 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |