Perrigo Company plc said it filed a Paragraph IV Abbreviated New Drug Application with the US Food and Drug Administration for a generic version of Finacea Foam (azelaic acid foam, 15%).
“Following notification from Perrigo, Bayer AG filed a patent litigation suit asserting patents listed in the Orange Book for Finacea Foam in the US District Court for the District of Delaware on February 15, 2018,” said Perrigo.
“This action formally initiates the litigation process under the Hatch-Waxman Act.”
Finacea Foam, 15% is a topical prescription medicine used to treat the inflammatory papules (raised spots) and pustules (pimple-like bumps) of mild to moderate rosacea.
Annual market sales for 2017 were $54 million.
Perrigo executive vice president John Wesolowski said: “This filing is another example of the hard work done by our R&D and legal teams to develop new generic products that lower the cost of healthcare for patients, consumers and families.”