8 November 2013Americas

Forest and Actavis settle over blood pressure drug

US pharmaceutical company Forest Laboratories and drug company Actavis have settled a legal dispute over a patent protecting blood pressure drug Bystoli (nebivolol).

The agreement also applies to Actavis’s subsidiaries.

Actavis and several companies had filed Abbreviated New Drug Applications (ANDAs) to market generic versions of Bystoli, a beta blocker used in tablet form to lower hypertension (chronic blood pressure), prompting a lawsuit from Forest.

Since the ANDAs were filed last year, the remaining defendants – Alkem, Amerigen, Glenmark, Hetero, Indchemie and Torrent – have all settled with Forest. Under the deals, the companies can launch generic versions of Bystolic either three months before the drug’s patent expires (2023) or on the date each company’s ANDA receives final approval by the US Food and Drug Administration (FDA), whichever is earlier.

The agreements themselves are subject to FDA approval.

According to Forest, while Bystolic has been shown to effectively lower blood pressure, the exact mechanism by which it works has not been “definitively established”.

The company’s other principle brands include Daliresp, a medicine used to treat chronic obstructive pulmonary disease, and anti-depressant drug Fetzima.

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