USFDA approves generic version of anti-depressant

Written by fe Bureau | Hyderabad | Updated: Dec 13 2013, 09:05am hrs
The US Food and Drug Administration (USFDA) has approved the first generic versions of Cymbalta, duloxetine delayed-release capsules, a prescription medicine used to treat depression and other conditions. This approval paves way for generic companies such as Aurobindo Pharma, Dr. Reddys Laboratories, Lupin, Sun Pharma Global FZE, Teva Pharmaceuticals USA and Torrent Pharmaceuticals to market duloxetine in various strengths in the US market.

Cymbalta, the fifth-largest selling drug in the world, is Eli Lillys best-selling drug with an annual sales of $4.7 billion. The drugs patent expired on Wednesday causing the entry of cheaper generic versions in the US market.

The drug accounted for 22% of Lilly revenue last year. In its recent earnings report, Eli Lilly reported that third quarter US sales of Cymbalta were more than $1 billion, an increase of 15% compared to the same period a year earlier. The company estimates fourth quarter sales will be around $500 million.