Singapore, Oct 30, 2008: Mylan’s Indian subsidiary, Matrix Laboratories has challenged Pfizer’s patents for its ‘Vfend’ tablets with the filing of its Abbreviated New Drug Application (ANDA). As Pfizer did not file a lawsuit against Matrix within the 45-day time period provided, Matrix's ANDA will be eligible for final approval as soon as regulatory review is complete. 

Matrix submitted its ANDA for Voriconazole Tablets, the generic version of Vfend, with the Food and Drug Admministration in April this year and believes it is the first company to submit a substantially complete ANDA. Under the provisions of the Hatch-Waxman Act, it is anticipated that Matrix will be entitled to 180 days of marketing exclusivity for Voriconazole upon FDA approval.

According to IMS Health, Vfend Tablets, a triazole antifungal agent, had annual US. sales of approximately $157 million for the 12 months ending June 30, 2008, for the 50 and 200mg strengths.

Mylan holds a 71.5% controlling interest in Hyderabad, India-based Matrix labs.