Perrigo Company announced that its partner Cobrek Pharmaceuticals, Inc has filed an Abbreviated New Drug Application (ANDA) for Clindamycin Phosphate Foam 1%, a generic version of Evoclin Foam 1%. The company believes that Cobrek is the first to file an ANDA with a Paragraph IV certification against Evoclin. Evoclin (clindamycin phosphate) Foam 1% is a topical antibiotic indicated for topical application in the treatment of acne vulgaris, and had sales of approximately $44 million for the 12 months ended January 2009, as measured by Wolters Kluwer Health.
The ANDA for Clindamycin Phosphate Foam, 1%, which was filed prior to enactment of the Q1 Programme Supplemental Funding Act of 2008 (Q1 Act), was timely amended to contain a Paragraph IV Certification in accordance with the Q1 Act. On March 13, 2009, Stiefel filed suit alleging patent infringement in the United States District Court for the District of Delaware against Perrigo and its partner Cobrek. Stiefel also has filed a Citizen Petition with the US Food and Drug Adminstration (FDA) seeking to have a 30 month stay of Cobrek's ANDA approval imposed. The FDA has not ruled, neither have the courts, regarding whether the Q1 Act entitles Stiefel to a 30 month stay.
Perrigo's chairman and CEO Joseph C Papa concluded, "This filing reflects our continuing investment in new products. We are the manufacturer and developer of this product as well as the exclusive sales and marketer. As always, Perrigo is committed to making quality healthcare more affordable for our customers and drive value for our shareholders."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products.