Perrigo Company plc issued the following announcement on Feb. 20.
Perrigo Company plc (NYSE; TASE: PRGO) today announced that it has filed a Paragraph IV Abbreviated New Drug Application with the U.S. 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 United States District Court for the District of Delaware on February 15, 2018. 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 and President Rx Pharmaceuticals John Wesolowski stated, "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."
Original source can be found here.