Matrix Laboratories Ltd, the subsidiary of Mylan Inc?s, having a 71.5% controlling interest, has challenged Pfizer Inc?s patents for its Vfend(R) tablets, 50 mg and 200 mg, with the filing of its Abbreviated New Drug Application (ANDA).
Pfizer did not file a lawsuit against Matrix within the 45-day time period provided by the Hatch-Waxman Act to initiate an automatic stay of regulatory approval. Therefore, 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 US Food and Drug Administration (FDA) on April 14, 2008, and believes it is the first company to submit a substantially complete ANDA containing a Paragraph IV certification. 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.
Vfend Tablets, a triazole anti-fungal agent, had annual US sales of approximately $157 million for the 12 months ended June 30, 2008, according to IMS Health.