Unigene, Upsher-Smith sue Apotex over osteoporosis nasal spray

By Elaine Rigoli

Tampa, Fla., July 25 - Unigene Laboratories, Inc. and Upsher-Smith Laboratories, Inc. have jointly filed in the U.S. District Court for the Southern District of New York a patent-infringement lawsuit against Apotex, Inc., a Canadian generic pharmaceutical manufacturer, and Apotex Corp., its U.S. subsidiary.

The suit was brought in response to Apotex's filing of an abbreviated New Drug Application (ANDA) seeking approval of a generic version of Fortical, the nasal calcitonin product for the treatment of postmenopausal osteoporosis that is manufactured by Unigene and marketed by Upsher-Smith.

The filing of the lawsuit automatically stays the Food and Drug Administration's approval of Apotex's ANDA for at least 30 months, unless an adverse court decision occurs earlier.

Apotex is the defendant in a patent-infringement lawsuit involving a nasal calcitonin formulation developed and patented by Novartis.

Unigene is a biopharmaceutical company located in Fairfield, N.J.

Upsher-Smith is a pharmaceutical company located in Maple Grove, Minn.

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