Actavis Seeks US Approval to Market Generic Version of Gilead’s PAH Drug

Dublin-based Actavis PLC said Friday that it is seeking approval from the US Food and Drug Administration (FDA) to sell a generic version of Gilead Sciences Inc.’s pulmonary arterial hypertension (PAH) drug.

The company confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the agency seeking approval to market Abrisentan Tablets, 5 mg and 10 mg. The drug is a generic version of Gilead’s Letairis, which was approved by the FDA in 2007 for treatment of patients with PAH.

Last Wednesday, Gilead, along with Royalty Pharma Collection Trust, filed a suit against Actavis to block the company from commercializing its generic product before the Letairis patent expires. In the US, the patent for Letairis is set to expire in 2018 and in the European Union (EU), the patent expires in 2020. According to Gilead, Letairis brought in global sales of $595 million in sales last year.

The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting 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 said that it believes it may be a “first applicant” to file an ANDA for the generic version of Letairis and may be entitled to 180 days of market exclusivity if the FDA approves the application.

Earlier this year, Watson Laboratories Inc., a subsidiary of Actavis, announced that it was seeking FDA approval to launch the generic version of Letairis, challenging the drug’s patents. The company claimed that one of the patents associated with the drug was invalid and therefore could not be enforced.

Last month, Actavis acquired Allergan, Inc. in a deal worth about $70.5 billion. The acquisition secured the company’s position among the top pharmaceutical companies worldwide.

Source: Actavis PLC

Last updated: 4/6/15; 11:25am EST

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