May 2011

It looks like Perrigo Co. will have another generic product to help grow its bottom line -- while it grows hair for retail customers.

Allegan-based Perrigo announced Monday that it has received approval from the U.S. Food and Drug Administration to make and market an over-the-counter, generic version of baldness fighter Men's Rogaine Foam. Perrigo sells generic and over-the-counter pharmaceuticals and nutritional products that major retailers sell under their own store labels.

Rogaine Foam has annual sales of about $60 million, as measured by Information Resources, Inc., according to information provided by Perrigo. It is a topical treatment used to try to regrow hair on the scalp. Minoxidil is the active ingredient in Rogaine.

The approval follows the resolution in February of a patent infringement lawsuit in which Stiefel Research Australia Pty. Ltd. had sought to prevent Perrigo's generic product launch.

Perrigo had been sued for patent infringement by Stiefel Research Australia, a GlaxoSmithKline company, when Perrigo submitted its Abbreviated New Drug Application to the FDA

According to a news release from Perrigo, "Under the terms of the settlement reached between the parties in February 2011, Perrigo can launch the generic version of Men’s Rogaine Foam in the U.S. on March 1, 2012, or earlier, under certain circumstances.”

According to the release, after its launch, Perrigo's product will get 180 days of generic market exclusivity before others can market similar products.

Rogaine was a former Pfizer Inc. product that was sold to Johnson & Johnson when Pfizer sold its Consumer Healthcare Products Division to J&J in 2006. The division encompassed all of Pfizer's over-the-counter products at that time.

Source

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