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news.Barr Laboratories has received approval from the FDA for its abbreviated new drug application to manufacture and market leflunomide tablets, a generic equivalent of Sanofi Aventis' Arava, for the treatment of rheumatoid arthritis. The company plans to launch its product immediately.
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Aventis’ main patent protection for Arava expired in September 2003 and a pediatric exclusivity on Arava expired in March 2004. There are other exclusivities related to the drug but Barr says that these will not affect its ability to manufacture and market its generic version of the product.
Barr’s Leflunomide Tablets, 10 mg & 20 mg, are indicated in adults for the treatment of active rheumatoid arthritis to reduce signs and symptoms and to inhibit structural damage as evidenced by X-ray erosions and joint space narrowing.
Barr’s generic version will compete in a market that had total combined annual sales of approximately $238 million, based on IMS sales data for the twelve months ended July 2005.