Teva will have 180-day exclusivity on the drug, the generic version of Merck's Proscar.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has announced today that the US Food and Drug Administration has granted final approval for its abbreviated new drug application (ANDA) to market its generic version of Merck’s Proscar (Finasteride) Tablets, 5 mg.
Teva said shipment of the product would begin immediately. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded 180 days of marketing exclusivity.
Teva’s Finasteride Tablets USP are indicated for treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms and to reduce the risk of the need for prostate surgery.
According to Teva, on the basis of IMS data annual brand product sales in the US were approximately $406 million for the twelve months ended March 2006.
Published by Globes [online], Israel business news - www.globes.co.il - on June 20, 2006
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