(Adds details, background)
LONDON Feb 9 Shire Plc's (SHP.L) kidney drug
Fosrenol has been threatened by generic competition in the
United States, the British speciality pharmaceuticals group said
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
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)