Pfizer has entered into a settlement and license agreement with Mylan Pharmaceuticals and Matrix Laboratories subsidiaries relating to Voriconazole Tablets, 50 mg and 200 mg, the generic version of Pfizer’s Vfend Tablets, a triazole antifungal agent.
Reportedly, Mylan’s Matrix was the first company to submit a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification to the US 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.
The agreement is limited to the tablet form of Vfend and does not cover Pfizer’s Vfend products for intravenous use or oral suspension. Pursuant to the agreement, Mylan will have the right to market voriconazole tablets in the US in the first quarter of 2011.
The agreement is subject to review by the US Department of Justice and the Federal Trade Commission.