Allergan challenges Merck's Noxafil patent in USA

Allergan (NYSE: ACT) has confirmed it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for posaconazole delayed-release tablets, a generic of Merck’s (NYSE: MRK) Noxafil.

Noxafil is an antifungal agent, indicated for prophylaxis of invasive Aspergillus and Candida infections in patients aged 13 and older, who are at high risk of developing these infections due to being immunocompromised.

Merck filed suit against Allergan on August 6, seeking to prevent it from commercializing its ANDA product, prior to the expiry of US Patent 5,661,151. Merck filed with the District Court for the District of New Jersey, under the provisions of the Hatch-Waxman Act. This resulted in a stay of final FDA approval of Allergan’s ANDA of up to 30 months from the date the plaintiffs received notice of Allergan’s ANDA filing or until final resolution of the matter before the court.