SILVER SPRING, Md. – The Food and Drug Administration has approved the first generic versions of a drug used to treat depression and other conditions, the agency said Wednesday.
The FDA announced the approval of generic duloxetine delayed-release capsules manufactured by Aurobindo Pharma, Dr. Reddy's Labs, Lupin, Sun Pharmaceutical Industries, Teva Pharmaceutical Industries and Torrent Pharmaceuticals.
The drug is a generic version of Eli Lilly's Cymbalta. Cymbalta had sales of $4.7 billion in 2012, making it the fifth top-selling drug that year, according to IMS Health. In addition to depression, Cymbalta is used to treat pain resulting from diabetic peripheral neuropathy, fibromyalgia and other causes. Most of Lilly's patents on Cymbalta expire this year or within the next couple of years, though its patent covering the use of the drug for fibromyalgia won't expire until 2019, according to FDA records.