ALLEGAN – Perrigo Company reported Monday it has received final approval
from the U.S. Food and Drug Administration to manufacture a generic brand of Olux Foam, a topical corticosteroid for treatment of dermatosis of the scalp.
Before that happens, however, Perrigo must await a decision later this month on a patent infringement lawsuit filed in 2005 by Connetics against Perrigo, the developer of Olux Foam. That suit was filed in the United States District Court for the District of New Jersey.
In response to a motion filed by Connetics on March 7, the Court
temporarily restrained Perrigo from manufacturing, using, offering to sell, selling or importing into the United States its product pending the outcome of a hearing on March 19. The Court will hear arguments on Perrigo’s pending Summary Judgment Motion as well as Connetics’ Motion for a Preliminary Injunction.
At stake is a lucrative new product line for Perrigo. Sales for the brand, Olux Foam, 0.05 percent, were approximately $85 million for the 12 months ending January 2008, according to Wolters Kluwer data. As the first filer, Perrigo could be eligible for 180 days of generic marketing exclusivity if the court gives it clearance to launch the new product.
“We are obviously excited about this approval. This approval reflects our on-going efforts to make quality healthcare more affordable for our customers and drive value for our shareholders,” said Perrigo’s Chairman Joseph Papa.
Perrigo is the world’s largest manufacturer of OTC pharmaceutical products for the store brand market. The company’s primary markets and locations of manufacturing facilities are the United States, Israel, Mexico and the United Kingdom.
For more information, click on Perrigo.Com
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