UPSHER-SMITH AND UNIGENE FILE PATENT SUIT AGAINST APOTEX

Canadian drugmaker Apotex has been sued by Unigene Laboratories and Upsher-Smith Laboratories for allegedly infringing on the patent for their postmenopausal osteoporosis nasal spray Fortical.

Unigene and Upsher-Smith filed the suit in the U.S. District Court for the Southern District of New York after Apotex submitted an abbreviated new drug application to market Fortical (calcitonin-salmon recombinant) Nasal Spray. Filing the suit automatically stays FDA approval of Apotex's application for 30 months, unless the court rules on the case before the end of the 30-month stay. Unigene manufactures Fortical and Upsher-Smith distributes it.

Ronald Levy, Unigene's executive vice president, said the company was "very enthusiastic" about the market potential of Fortical, and said that the drug had, as of the end of May, captured 24 percent of the nasal calcitonin market.

The FDA approved Fortical last year.

Apotex said it does not comment on ongoing litigation.