Mylan gets FDA OK to market generic version of Norvasc
Mylan said in a statement that since it was the first generic company to file with the FDA on all strengths of Norvasc, the company is eligible for 180 days of market exclusivity.
The approval covers tablets of Norvasc's active ingredient, amlodipine besylate, in strengths of 2.5 milligrams, 5 milligrams, and 10 milligrams.
Mylan said the exclusivity period will begin with its launch of the product or with the resolution of a patent lawsuit between it and Pfizer, whichever comes first.
Two patents protect Norvasc -- the first protects the amlodipine molecule, and the second protects the besylate salt formulation of the molecule.
The patents expire Jan. 31, 2007, and Sept. 25, 2007, respectively.