The product is a generic version of GlaxoSmithKline’s Avodart (dutasteride), which is a triple 5α-reductase inhibitor that prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. DHT is involved in the development of benign prostatic hyperplasia (BPH).

Avodart is used to treat BPH in men with an enlarged prostate. It can help treat BPH and its complications, such as prostate-driven urinary problems and may reduce the need for BPH-related prostate surgery.

The patent on Avodart expires in the US in November 2015. Teva was first to file its abbreviated new drug application for a generic version of dutasteride and expects to benefit from several weeks of exclusivity.

Avodart capsules had annual sales of approximately US$467 million in the US, according to IMS data as of July 2015.

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