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news.Irish pharmaceutical firm Actavis has submitted an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) seeking approval to market Ambrisentan Tablets, 5mg and 10mg.
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The ANDA product is a generic version of Gilead Sciences’ Letairis, which is designed to treat patients with pulmonary arterial hypertension (PAH).
On 01 April 2015, Gilead and Royalty Pharma Collection Trust have filed lawsuit under the provisions of the Hatch-Waxman Act against Actavis in the US District Court for the District of Delaware.
Gilead is seeking the court to prevent Actavis from commercializing its ANDA product prior to the expiration of US Patent number RE42,462.
The lawsuit results in a stay of final FDA approval of Actavis’ ANDA for up to 30 months from the date the plaintiffs received notice of Actavis’ ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
Actavis believes it may be a first applicant to file an ANDA for the generic version of Letairis.
If the ANDA gets approval from the FDA, it may be entitled to 180 days of generic market exclusivity.
The Irish firm is focused on developing, manufacturing and commercializing generic, brand, branded generic, legacy brands and over-the-counter (OTC) pharmaceutical products for patients worldwide.