Mylan Pharmaceuticals and Matrix Laboratories enter into license agreement with Pfizer

Oct 15 2009

Mylan Inc. (Nasdaq: MYL) today announced that the company's Mylan Pharmaceuticals and Matrix Laboratories subsidiaries entered into a settlement and license agreement with Pfizer Inc. relating to Voriconazole Tablets, 50 mg and 200 mg, the generic version of Pfizer's Vfend® Tablets, a triazole antifungal agent.

Mylan's Matrix was the first company to submit a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification to the U.S. Food and Drug Administration (FDA) and therefore believes it will be eligible for 180 days of marketing exclusivity upon commercial marketing of the product, as provided under the provisions of the 1984 Hatch Waxman Act.

Pursuant to the agreement, Mylan will have the right to market Voriconazole Tablets in the U.S. in the first quarter of 2011. Additional details of the agreement with Pfizer remain confidential; the agreement is subject to the review by the U.S. Department of Justice and the Federal Trade Commission.

Voriconazole Tablets, 50 mg and 200 mg, had U.S. sales of $164 million for the 12 months ending June 30, according to IMS Health. Currently, Mylan has 121 ANDAs pending FDA approval representing $85.7 billion in annual brand sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $17.9 billion in annual brand sales, according to IMS Health.