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Warner Chilcott Files New Lawsuit for Infringement of LOESTRIN(R) 24 FE and FEMCON(R) FE Patents
Date:9/10/2009

ARDEE, Ireland, Sept. 10 /PRNewswire-FirstCall/ -- Warner Chilcott plc (Nasdaq: WCRX) announced today that one of its subsidiaries has filed two lawsuits against Lupin Limited and its wholly owned subsidiary Lupin Pharmaceuticals, Inc. (collectively "Lupin") in the District Court for the District of Delaware for infringement of Warner Chilcott's U.S. Patent Nos. 5,552,394 (the "'394 Patent") and 6,667,050 (the "'050 Patent"), which cover oral contraceptives LOESTRIN 24 FE and FEMCON FE, respectively.

The lawsuits are in response to the submission of two Abbreviated New Drug Applications ("ANDAs") to the U.S. Food and Drug Administration ("FDA") by Lupin requesting approval to manufacture and sell generic versions of LOESTRIN 24 FE and FEMCON FE prior to the expiration of the '394 Patent in July 2014 and the '050 Patent in April 2019, respectively.

The Company's lawsuits result in a stay of FDA approval of Lupin's ANDAs for 30 months from the date of the Company's receipt of notice with respect to such ANDAs (subject to the prior resolution of the matters before the court). Under current law, the FDA may not approve Lupin's ANDAs until six months following the date on which the "first filer" with respect to each of LOESTRIN 24 FE and FEMCON FE enters the market. Pursuant to the Company's settlement agreement with Watson Pharmaceuticals, Inc. ("Watson"), the "first filer" with respect to LOESTRIN 24 FE, Watson may not enter the market until the earlier of January 22, 2014 or the date on which another generic version of LOESTRIN 24 FE enters the market. Pursuant to the Company's settlement agreement with a current subsidiary of Teva Pharmaceuticals, Inc. ("Teva"), the "first filer" with respect to FEMCON FE, Teva may not enter the market until the earlier of July 1, 2012 or, among othe
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SOURCE Warner Chilcott plc
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