Attn: Business/City Editors
January 25, 2006
For Immediate Release
Apotex Receives Approval for First Generic Plavix®
WESTON, FLORIDA, U.S.A. – 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.
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For further information:
Mr. Elie Betito
Director Public & Government Affairs
Tel: 416-749-9300 Ext. 7366
Cell: 416) 558-5491
ebetito@apotex.com
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