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ALLEGAN, Mich. — Perrigo Co. has received final approval from the Food and Drug Administration for its abbreviated new drug application for over-the-counter minoxidil foam, a generic version of Men’s Rogaine Foam.
Perrigo said Monday that it had been sued for patent infringement by Stiefel Research Australia Pty. Ltd., a GlaxoSmithKline, when it submitted its Paragraph IV ANDA.
Under the terms of the settlement reached between the parties in February, Perrigo can launch the generic of Men’s Rogaine Foam in the United States on March 1, 2012, or earlier, under certain circumstances. The product will be entitled to 180 days of generic exclusivity upon launch, according to Perrigo
Rogaine Foam is used to regrow hair on the top of the scalp and has annual sales of about $60 million, based on figures from SymphonyIRI Group, Perrigo reported.
"This is another example of Perrigo’s commitment to bring new products to market,"
Perrigo chairman and chief executive officer Joseph Papa said in a statement. "Perrigo continues to deliver on its mission to provide quality, affordable health care to consumers."
