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Warner, with headquarters based in Bermuda, released its oral contraceptive Loestrin 24 FE in April. In a statement, it said Watson Laboratories Inc., a division of Watson Pharmaceuticals Inc., sent notification it was filing for a drug application to make a generic version of Loestrin.
"Warner Chilcott is currently reviewing the detail of the paragraph IV notice letter from Watson and continues to have full confidence in its intellectual property protecting Loestrin," the company said.
Its patent on the drug does not expire until 2014. The challenge means that Watson is either claiming Warner's patent is invalid or that Watson is not infringing on it patent rights by making the generic version of the drug. Watson did not comment on the reasons for the challenge.
The move by Watson means Warner now has 45 days to either file patent litigation or take no action.
Warner develops a variety of pharmaceuticals for women's health care, including contraceptives and hormone replacement therapies. It also makes a variety of dermatologic treatments.