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Federal Trade Commission Files Complaint Against Par Pharmaceutical Over Court-Approved AndroGel(R) Litigation Settlement
Date:2/2/2009

WOODCLIFF LAKE, N.J., Feb. 2 /PRNewswire-FirstCall/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that it learned after the close of business on Friday, January 30, 2009 that the Federal Trade Commission and the California Attorney General filed a lawsuit against Par in the U.S. District Court for the District of Central California. The FTC lawsuit makes antitrust and other allegations about a patent settlement agreement that was approved by the U.S. District Court for the Northern District of Georgia in 2006. The 2006 court-approved settlement ended litigation between Par Pharmaceutical, Paddock Laboratories and plaintiff Solvay Pharmaceuticals over Paddock and Par's filing of an Abbreviated New Drug Application for a generic version of Solvay's AndroGel(R) 1% testosterone gel product.

Under the terms of the 2006 court-approved settlement, Par is permitted to begin marketing testosterone gel 1% in August 2015 -- five years prior to the expiration of the AndroGel(R) patent, which expires on August 30, 2020, excluding AndroGel(R)'s six-month pediatric marketing exclusivity.

Par was the second ANDA filer for testosterone gel 1% and therefore not eligible for 180 days of marketing exclusivity. However, the 2006 settlement allowed Par's early entry date to be the same as that obtained by the first ANDA filer. Par issued a press release on September 13, 2006 addressing further details of the 2006 court-approved settlement and contemporaneous business agreements.

The U.S. District Court for the Northern District of Georgia Approved the Settlement in 2006

In September 2006, Par's settlement with the makers of AndroGel(R) was entered and approved by the U.S. District Court for the Northern District of Georgia. The court's Consent Judgment described the settlement as "a good
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SOURCE Par Pharmaceutical Companies, Inc.
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