Apotex launches generic Plavix; Bristol-Myers Squibb, sanofi-aventis mull legal options

By Elaine Rigoli

Tampa, Fla., Aug. 8 - Apotex Corp. has launched clopidogrel bisulfate 75 mg tablets, the generic equivalent of sanofi-aventis SA's anti-clotting drug Plavix, which is marketed in the United States by Bristol-Myers Squibb Co.

On July 28, numerous state attorneys general in the United States rejected a modified settlement agreement submitted in June by the three companies to the Federal Trade Commission and the states that would have delayed Apotex's release of the generic version.

As the first generic company to file an Abbreviated New Drug Application with the Food and Drug Administration for clopidogrel, Apotex will have 180 days of market exclusivity for the product.

Plavix is currently Bristol-Myers Squibb's largest product with net sales of roughly $3.8 billion for the year ended Dec. 31, 2005. The development of generic competition could be material to the company's financial condition and liquidity.

Bristol-Myers Squibb and sanofi-aventis said they intend to pursue enforcement of their Plavix patent rights.

Apotex is a generic medicine provider with headquarters in Weston, Ontario.

Bristol-Myers Squibb is a pharmaceutical company with headquarters in New York.

sanofi-aventis is a Paris-based pharmaceutical company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.