AndroGel (1% testosterone gel): FTC Filed Complaint Against Par Pharma and Watson Over Georgia District Court Approved Settlement

The US Federal Trade Commission has filed suit in US Federal court in an attempt to block a deal in which an innovator of testosterone-replacement drug paid the generic competitors (Par, Paddock and Watson) to delay generic entry. The FTC said that "Pay-for-Delay" agreement are not in public interest.

Par Pharmaceutical announced (in a press release Here) that the Federal Trade Commission (FTC) 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® 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® following patent:
US6503894 (Expiry: Mar 1, 2021 with PED): Which covers a pharmaceutical composition, consisting essentially of: a. about 0.5% to about 10% testosterone; b. about 30% to about 98% alcohol selected from the group consisting of ethanol and isopropanol; c. about 0.1% to about 5% isopropyl myristate; d. about 1% to about 5% sodium hydroxide; and e. about 0.1% to about 5% of a gelling agent, wherein the percentages of components are weight to weight of the composition.
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.
Another generic player Watson (first para IV filer) have announced ( in a press release Here)
that the U.S. Federal Trade Commission (FTC) and the State of California have filed a lawsuit in the United States District Court for the Central District of California alleging that the Company's 2006 patent lawsuit settlement with Solvay Pharmaceuticals Inc. related to AndroGel(R) 1% (testosterone gel) CIII is unlawful.
Earlier in 2003, Watson submitted an Abbreviated New Drug Application (ANDA) with para IV certification against ‘893 patent, seeking approval to market a generic version of AndroGel. Solvay initiated litigation against Watson alleging that its product infringed Solvay's patent. Under terms of a 2006 settlement agreement, Solvay granted Watson a non-exclusive license to the U.S. patents covering AndroGel. Watson agreed not to commence marketing its generic equivalent product until August 31, 2015 or the date on which another generic product enters the U.S. market, whichever occurs first. Additionally, Watson agreed to forfeit its 180-day marketing exclusivity on the product awarded under the Hatch-Waxman Act.