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LONDON, Feb 9 (Reuters) - Shire Plc’s (SHP.L) kidney drug Fosrenol has been threatened by generic competition in the United States, the British speciality pharmaceuticals group said on Monday.
Barr Laboratories Inc, which was acquired late last year by Israel’s Teva Pharmaceutical Industries Ltd (TEVA.TA), and Mylan Inc (MYL.O) have both submitted so-called Paragraph IV notice letters announcing plans to sell generic versions of the 500 mg, 750 mg and 1 gram formulations of the medicine.
Shire said it was reviewing the details of the letters but believed its U.S. patents provided robust and sustainable protection. Fosrenol is covered by patents expiring in 2018 and 2024.
Shire has 45 days from the date of each notice letter to decide if it will file a patent infringement suit. The two letters were dated Feb. 2 and 4. (Reporting by Ben Hirschler; Editing by Rupert Winchester)