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Biotech / Medical : IVX: IVAX Corporation

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To: Jim Oravetz who wrote (64)4/8/2005 12:41:56 PM
From: Jim Oravetz  Read Replies (1) of 78
 
FTC Rejects IVAX Claim On Generic Of Merck's Zocor
DOW JONES NEWSWIRES
April 7, 2005 4:12 p.m.

WASHINGTON -- The Federal Trade Commission urged the Food and Drug Administration to reject Ivax Pharmaceuticals Inc.'s (IVX) petition for a 180-day marketing exclusivity period for its generic version of cholesterol drug Zocor.

Ivax submitted an abbreviated new drug application for generic Zocor in 2000 and was entitled to exclusivity under two of Merck & Co.'s (MRK) patent claims as mandated by the Hatch-Waxman Act. However, the FDA later removed these two patents from its patent list commonly known as the Orange Book, after determining that they were related to an active ingredient already covered by a separate Merck patent.

Ivax's petition requests continuing exclusivity on the generic drug, which the company expects to begin marketing in 2006.

An Ivax representative wasn't immediately available to comment on the FTC's response to the petition.

The FTC, which has brought a number of patent-related antitrust cases against drug companies, argues that Ivax is mistaken in its characterization of the 180-day exclusivity as a right instead of an incentive to foster competition and to strengthen patents.
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