Watson seeks approval for acne, bronchospasm drugs
PARSIPPANY, N.J. — Generic drug maker Watson Pharmaceuticals is challenging the patent protection on a drug for acne and a drug for bronchospasm, the company said Monday.
Watson said it had filed a regulatory application with the Food and Drug Administration for a generic version of Galderma Labs' Epiduo Gel (adapalene and benzoyl peroxide), a topical ointment for treating severe acne in patients ages 12 years and older. In response, Galderma filed suit against Watson on Friday in the U.S. District Court for the Northern District of Texas Dallas Division to prevent Watson from commercializing its product before the expiration of Galderma's patents. Epiduo Gel had sales of about $199 million during the 12-month period ended in March, according to IMS Health.
The generis drug maker also filed an FDA approval application for legalbuterol tartrate inhalation aerosol, a generic version of Sunovion Pharmaceuticals' Xopenox HFA, used to treat bronchospasm in patients ages 4 years and older with reversible obstructive airway disease. Sunovion filed suit against Watson on Friday in the U.S. District Court for the District of Delaware to prevent Watson from commercializing the drug. Xopenox HFA had sales of about $148 million during the 12-month period ended in March, according to IMS Health data.