Actoplus Met and Actos: Mylan enters into settlement agreements with Takeda Pharmaceutical

March 20, 2016

Mylan Pharmaceuticals also was one of the first companies to submit a substantially complete ANDA containing a Paragraph IV certification to the FDA for Actos and believes it will be eligible for 180 days of shared marketing exclusivity upon commercial marketing of the product. Pursuant to the settlement agreement, Mylan will have the right to market Pioglitazone HCl in the U.S. on Aug. 17, 2012, or earlier, under certain circumstances. Actos had 2009 U.S. sales of $3.4 billion, according to IMS Health.

Additional details of both agreements remain confidential and remain subject to review by the U.S. Department of Justice and the Federal Trade Commission.

Currently, Mylan has 142 ANDAs pending U.S. Food and Drug Administration approval representing $93.8 billion in annual brand sales; 40 of these pending ANDAs are potential first-to-file opportunities, representing $20 billion in annual brand sales for the 12 months ending Dec. 31, 2010, according to IMS Health.

SOURCE Mylan Inc.