Biotech Values

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Apotex plans to launch generic Norvasc very soon
Thu Mar 22, 2007 6:38pm ET

UPDATE 1-Apotex plans to launch generic Norvasc very soon
Apotex plans to launch generic Norvasc very soon
UPDATE 2-Generic Norvasc seen soon, as decision hits Pfizer


NEW YORK, March 22 (Reuters) - Apotex Inc. on Thursday said it plans to launch its generic form of Pfizer Inc.'s (PFE.N: Quote, Profile , Research) Norvasc hypertension drug "in the very near future," following a federal appeals court decision Thursday that invalidated Pfizer's basic patent on the drug.

By finding the Pfizer patent invalid, "the court is allowing Apotex to obtain final approval for its generic," Apotex said.

Some analysts on Thursday speculated Apotex would have to wait months to launch its generic because it had not yet received final approval from the U.S. Food and Drug Administration

By contrast, they predicted Mylan Laboratories Inc. (MYL.N: Quote, Profile , Research) would introduce its own Norvasc generic within days because it had already received final U.S. approval.

Moreover, because Mylan was the first generic company to submit a marketing application to the FDA, it was expected to have six months of U.S. marketing exclusivity for its product.

"Because the limiting patent (on Norvasc) expires in two days, no company will have exclusivity over the product," Apotex said. It also said the court ruling strips Norvasc of its final six months of marketing exclusivity, which Pfizer had won as a result of conducting pediatric trials of the $4.9 billion-a-year drug.

Due to price competition, the cost of generic Norvasc is likely to be far less if both Mylan and Apotex simultaneously launch their products


Link: http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn:newsml:reuters.com:20070322:MTFH68642_2...