Aclaris Therapeutics announced the company, together with Allergan, has filed a patent infringement lawsuit in the United States District Court for the District of Delaware against Taro Pharmaceuticals, related to an Abbreviated New Drug Application (ANDA) that Taro filed with the U.S. Food and Drug Administration (FDA) to market a generic version of RHOFADE® (oxymetazoline hydrochloride) cream, 1% (RHOFADE).
The lawsuit claims infringement of U.S. Patent Nos. 7,812,049, 8,420,688, 8,815,929, 9,974,773 and 10,335,391, which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, for RHOFADE. Aclaris Therapeutics received a Paragraph IV Notice Letter from Taro dated August 28, 2019, advising that Taro had submitted an ANDA to the FDA seeking approval from the FDA to manufacture and market a generic version of RHOFADE prior to the expiration of the Orange Book-listed patents.
Aclaris intends to vigorously enforce its intellectual property rights relating to RHOFADE.