Glenmark Pharmaceuticals has been granted tentative approval by the US Food & Drug Administration (FDA) for its azelaic acid gel, a generic version of Bayer Healthcare’s Finacea topical gel. Glenmark will market this product upon receiving final approval of its azelaic acid gel ANDA.
The patent listed in the Orange Book for Finacea topical gel, which is used to treat mild to moderate rosacea (a skin condition marked by red eruptions, usually on the cheeks and nose), is scheduled to expire on November 18, 2018.
According to IMS Health sales data for the 12 month period ending December 2015, the Finacea market achieved annual sales of approximately $ 128 million.
