Israel's Teva Pharmaceutical Industries has own approval for a generic version of Merck & Co's enlarged prostate drug Proscar, and will launch the drug straight away.
The world’s number one generics house said it was the first to file for approval of Proscar (finasteride) tablets 5mg in the USA, so it has been awarded 180 days of marketing exclusivity.
Teva's finasteride tablets USP are indicated for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate to improve symptoms and to reduce the risk of the need for prostate surgery.
Annual brand product sales in the USA were approximately $406 million for the 12 months ended March 2006, based on IMS data, with the total world market for BPH treatments in the region of $4 billion.
Proscar is the lead drug in the 5-alpha reductase inhibitor class of BPH drugs, and the second most commonly prescribed drug for the condition behing Astellas’ Harnal (tamsulosin), although it has recently experienced increased competition from GlaxoSmithKline’s Avodart (dutasteride), which debuted in 2003.
Dr Reddy's has signed an agreement with Merck to allow it sell an 'authorised generic' version of Proscar now that the patent protection on the drug has expired.