Apotex Receives Approval for First Generic Plavix®
Weston, Florida, January 25, 2006 -- Apotex Corp. today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA)for Clopidogrel bisulfate 75 mg tablets.
Apotex is currently involved in patent litigation with Sanofi - Aventis over the validity and enforceability of U.S. Patent No. 4,847,265 pending in U.S. District Court of the Southern District of New York. The trial currently is set to begin in April 2006. Apotex was the first generic to file with the FDA, and thus is entitled to 180-days of generic market exclusivity. Apotex is not releasing details regarding the possible launch of the product at this time.
Apotex Chief Executive Officer Dr. Barry Sherman said: “Apotex is confident that the patent will be held invalid and that an affordable generic alternative to Plavix® will be available to consumers. We have been fighting for this for years and are committed to ensuring that the product comes to market as soon as the time is right.”
Clopidogrel is the generic equivalent of Sanofi’s Plavix®, which is marketed in the U.S by Bristol Myers Squibb. Annual sales for Clopidogrel 75 mg tablets in the U.S. are approximately $3.3 billion.
The Apotex Group manufactures more than 200 different high-quality generic pharmaceuticals, used by millions of patients worldwide. Its product line includes oral solids, liquids, injectables, nasal sprays, ophthalmics and inhalation solutions.
Plavix® is a registered trademark of Sanofi-Synthelabo.
Apotex Corp. is the U.S. subsidiary of Apotex Inc., the largest Canadian-owned manufacturer of prescription drugs. Through its sales and marketing headquarters in Weston, Florida and operations center in Indianapolis, Apotex Corp. is committed to providing safe and affordable generic medicines. Products manufactured and marketed by the Apotex Group are sold in 115 countries around the world. For more information visit apotexcorp.com.
Source: Apotex Corp. |
