A subsidiary of The Perrigo Company (Nasdaq: PRGO), Perrigo Israel Pharmaceuticals, has been granted USFDA tentative approval on its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Topical Foam, 0.05%.
Clobetasol Propionate Topical Foam, 0.05% would be the generic version of the listed drug Olux® Foam, 0.05% (used to treat moderate to severe scalp dermatoses, and to treat mild to moderate plaque-type psoriasis of the body) by Connetics Corporation (Nasdaq: CNCT) which is still subject to a period of patent protection.
Perrigo’s filed ANDA contained a paragraph IV patent certification stating that the patent is invalid, unenforceable, or will not be infringed under this ANDA.
Final approval will not be granted until the expiration of the 30-month period provided under the Hatch-Waxman Act, unless, before that time, the patent expires or is judged to be invalid or not infringed.
On October 19, 2005, Connetics filed suit in the U. S. District Court of New Jersey to prevent Perrigo from proceeding with the commercialization of its product. Litigation is currently ongoing.
Upon final USFDA approval and if the legal action is won, Perrigo expects to be granted 180 days of generic marketing exclusivity.
Source: The Perrigo Company (a pdf file)
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