Mylan gets approval for Nisoldipine ER Tablets with 180 days exclusivity

Mylan Inc.has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Nisoldipine Extended-release Tablets, 8.5 mg, 17 mg, 25.5 mg and 34 mg. Earlier Mylan has developed the different strengths like 20 mg, 30 mg and 40 mg but later discontinued from the market. As Mylan was the first ANDA filer with paragraph IV certification against concerned patent listed in orange book for Sular® (Nisoldipine ER Tablets) of Shionogi Pharma, Mylan has the 180 days exclusivity to market the generic version of Sular® without any competition of other generics.

Nisoldipine ER Tablets are the generic version of Shionogi Pharma's Sular® Tablets, a treatment for hypertension. Nisoldipine ER Tablets had U.S. sales of approximately $103 million for the 12 months ending Sept. 30, 2010, according to IMS.