Sun Pharmaceutical Industries announced that Ranbaxy Pharmaceuticals Inc. (Ranbaxy), a wholly-owned subsidiary, along with its partners, Cipher Pharmaceuticals Inc. (Cipher) and Galephar Pharmaceutical Research, Inc. (Galephar) have entered into a settlement agreement with Actavis Group (Actavis) that dismisses the patent litigation suit relating to Actavis’ Abbreviated New Drug Application (ANDA) for a generic version of Absorica (isotretinoin capsules). Absorica is the registered trademark of Ranbaxy Laboratories Inc.
As part of the settlement agreement, Ranbaxy, Cipher and Galephar have entered into a non-exclusive license agreement with Actavis under which Actavis may begin selling its generic version of Absorica in the US on December 27, 2020 (approximately nine months prior to the expiration of the patents in September 2021) or earlier under certain circumstances. The other terms of the agreement are confidential. The settlement agreement is subject to review by the US Federal Trade Commission and the US Department of Justice.