DRL launches generic version of mental disorder drug in US

Two days after expiry of AstraZeneca's blockbuster drug Seroquel (Quetiapine fumarate), Dr Reddy's Laboratories (DRL) today announced the launch of the generic version of the drug in the US market.

The company has launched the drug in strengths of 25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg.

Seroquel, which is used in the treatment of bipolar depression and bipolar mania-antipsyiotic, had US sales of approximately USD 4.6 billion last year, according to IMS Health.

"Dr Reddy's Laboratories announced today that it has launched Quetiapine fumarate tablets (25 mg, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg), a bio-equivalent generic version of Seroquel tablets in the US market on March 27, 2012, following the approval by the United States Food & Drug Administration of Dr Reddy's ANDA for Quetiapine fumarate tablets," DRL said in a statement.

On 23 March, the US District Court for the District of Columbia issued an opinion and order in AstraZeneca's lawsuit against the US Food and Drug Administration (FDA) regarding final marketing approval of generic quetiapine.

The Court denied the company's request for a preliminary injunction and dismissed the lawsuit.

In its lawsuit, AstraZeneca sought an injunction barring the FDA from granting final marketing approval of generic quetiapine until December 2, 2012 when regulatory exclusivity expires on important clinical trial data, or, alternatively, at least until a federal court had a meaningful opportunity to review imminent FDA action regarding the pending generic marketing applications.

Shares of Dr Reddy's were being quoted at Rs 1,711 apiece on the BSE, up 1.85% in the early trade.