Actavis announced on 31 October 2013 that it had filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market generic isotretinoin capsules in 10, 20, 30 and 40 mg dosages. Ranbaxy’s Absorica is a retinoid indicated for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older.

Ranbaxy, along with innovator firms Cipher Pharmaceuticals and Galephar Pharmaceutical Research, filed a suit against Actavis on 29 October 2013 in the District Court of New Jersey. The lawsuit aims to prevent Actavis from commercializing its ANDA product prior to the expiration of US Patent No. 8,367,102. The legal case prevents final FDA approval of Actavis’ ANDA for up to 30 months or until final resolution of the matter before the court.

Actavis believes it may be a ‘first applicant’ to file an ANDA for the generic version of Absorica and, should its ANDA be approved, may be entitled to 180 days of generics market exclusivity.

For the 12 months ending 30 September 2013, Absorica had total US sales of approximately US$97 million, according to IMS Health.

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