Perrigo Co. has settled Hatch-Waxman litigation for its clobetasol propionate emulsion foam 0.05% brought by Stiefel Research Australia Pty. Ltd., a GlaxoSmithKline company.


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Settlement clears Perrigo to launch clobetasol foam

June 11th, 2012

ALLEGAN, Mich. – Perrigo Co. has settled Hatch-Waxman litigation for its clobetasol propionate emulsion foam 0.05% brought by Stiefel Research Australia Pty. Ltd., a GlaxoSmithKline company.

Perrigo said Monday that under the settlement it can launch a generic version of Stiefel's Olux-E Foam 0.05% on Feb. 1, 2013, or earlier under certain circumstances.

Olux-E Foam, indicated for the treatment of psoriasis and inflammation and itching from other skin conditions, has annual sales of about $40 million according to data from Wolters Kluwer cited by Perrigo.

Perrigo reported that it was the first applicant to submit a substantially complete Abbreviated New Drug Application (ANDA) with a paragraph IV certification and is entitled to 180 days of marketing exclusivity for its product. The company said it received tentative approval for the ANDA in October 2011, and this product stems from a collaboration with Cobrek Pharmaceuticals.

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