Perrigo Co. plc said Bayer AG sued the company for alleged patent infringement over a generic version of Finacea Foam, a topical gel for mild to moderate rosacea.
Dublin-based Perrigo filed a paragraph IV abbreviated new drug application, or ANDA, with the U.S. Food and Drug Administration for the generic version of Bayer's Finacea.
In a paragraph IV filing, the generic company says the generic product does not infringe the listed patents in the FDA's Orange Book, or that such patents are invalid or unenforceable. Additionally, the generic applicant must notify the maker of the branded drug and other patent holders of the ANDA and patent challenge.
Bayer filed a patent litigation suit against Perrigo in the U.S. District Court for the District of Delaware on Feb. 15, after receiving the notification from Perrigo. The move triggered the litigation process under the Hatch-Waxman Act. The lawsuit entails a 30-month postponement of a possible FDA approval to give the companies time to assert their patent rights before a court.
Finacea foam, or azelaic acid foam, is used to treat the raised spots and pimple-like bumps caused by rosacea, a common skin disease. The drug had annual market sales of $54 million in 2017.