Clindamycin Phosphate Aerosol Foam 1%(Evoclin): Perrigo and Partner Cobrek filed Para IV; innovator sued Coberk

Perrigo Company today announced (in a press release Here) that its partner Cobrek Pharma has filed an Abbreviated New Drug Application (ANDA) for Clindamycin Phosphate Aerosol Foam 1%, a generic version of Evoclin(R) Foam 1%. The Company believes that Cobrek is the first to file an ANDA with a Paragraph IV certification against Evoclin(R).
The ANDA for Clindamycin Phosphate Foam, 1%, which was filed prior to enactment of the Q1 Program Supplemental Funding Act of 2008 (the "Q1 Act"), was timely amended to contain a Paragraph IV Certification in accordance with the Q1 Act. Innovator STIEFEL LABS INC has listed following patents in Orange Book:
US7141237 (Expiry: Jan 23, 2024): Which covers a topical delivery composition in a pressurized container, said composition comprising: up to 15% w/w of clindamycin phosphate; from about 83% to about 97.9% w/w of a quick-breaking foaming agent, wherein said quick-breaking foaming agent comprises a C1-C6 alcohol, a C14-C22 alcohol, water, and a surfactant; and from about 2% to about 7% w/w of an aerosol propellant selected from the group consisting of a hydrocarbon, a chlorofluorocarbon, dimethyl ether, hydrofluorocarbons and a mixture thereof, a base; and wherein said composition is a quick-breaking temperature sensitive foam after release from said container.
US7374747 (Expiry: Aug 9, 2026): A method for treating a bacteria-mediated disease, said method comprising: applying a quick-breaking temperature sensitive foam composition to the skin of a subject in need thereof, said composition comprising: up to 15% w/w of clindamycin phosphate; from about 83% to about 97.9% w/w of a quick-breaking foaming agent, wherein said quick-breaking foaming agent comprises a C1-C6 alcohol, a C14-C22 alcohol, water, and a surfactant; from about 2% to about 7% w/w of an aerosol propellant selected from the group consisting of a hydrocarbon, a chlorofluorocarbon, dimethyl ether, hydrofluorocarbons and a mixture thereof; and a base, to treat said bacteria-mediated disease.
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 U.S. Food and Drug Administration 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.
Evoclin(R) (clindamycin phosphate) Foam 1% is a topical antibiotic indicated for topical application in the treatment of acne vulgaris, and contains clindamycin phosphate,USP, at a concentration equivalent to 10 mg clindamycin per gram in a hydroethanolic foam vehicle consisting of cetyl alcohol, ethanol, polysorbate 60, potassium hydroxide, propylene glycol, purified water, and stearyl alcohol pressurized with a hydrocarbon (propane/butane) propellant.Evoclin had sales of approximately $44 million for the 12 months ended January 2009, as measured by Wolters Kluwer Health.