The company’s ANDA product is a generic version of Merck’s Noxafil which is an antifungal agent indicated to treat prophylaxis of invasive Aspergillus and Candida infections.
Noxafil is indicated to treat patients 13 years of age and older, who are at high-risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplantation recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
In August, Merck Sharp & Dohme filed a suit against Allergan in the US District Court for the District of New Jersey seeking to prevent the Irish firm from commercializing its ANDA product prior to the expiration of US Patent No. 5,661,151.
The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Allergan’s ANDA for up to 30 months from the date the plaintiffs received notice of the ANDA filing or until final resolution of the matter before the court.
Allergan noted that based on available information, it may be the first applicant to file an ANDA for the generic version of Noxafil and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
According to IMS Health data, for the 12 months ending 30 June 2015, Noxafil had global sales of about $143.6m.