People who spend hundreds of dollars each month for the blockbuster drug Cymbalta will soon have much cheaper alternatives available.
The Food and Drug Administration has given approval to six drug makers to begin marketing the first generic versions of duloxetine, which is sold under the brand name Cymbalta by Eli Lilly.
The move was widely expected, as Lilly’s patent on the drug expired Wednesday. Cymbalta has been Lilly’s best-selling drug and posted sales of $4.7 billion in 2012, making it the fifth highest selling medication in the world.
Cymbalta was originally developed as an anti-depressant, but is also widely prescribed as a treatment for fibromyalgia, diabetic nerve pain and other types of chronic pain.
The FDA approved six generic versions of the pill from Teva Pharmaceuticals, Dr. Reddy’s, Sun Pharma, Torrent Pharmaceuticals, Aurobindo Pharma, and India’s Lupin.
“Health care professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” said Kathleen Uhl, MD, acting director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.
“Generic drugs offer greater access to health care for many people.”
The generic versions of duloxetine are likely to be much cheaper than Cymbalta. A 30-day supply of Cymbalta 60 mg capsules sells for nearly $300 at major pharmacies.
Dr. Reddy’s generic version of Cymbalta will be the only one on the market for the first 180 days. After that, the other drug makers can release their versions, which is likely to drive prices even lower.
Common adverse reactions reported by people taking Cymbalta/Duloxetine include nausea, dry mouth, drowsiness, fatigue, decreased appetite, increased sweating, and dizziness.
Cymbalta/Duloxetine also have boxed warnings about the increased risk of suicidal thinking and behavior during initial treatment in children and young adults.
The loss of Cymbalta is the latest in a series of patent expirations faced by Lilly. In 2011, the company’s all-time best selling drug, the anti-psychotic Zyprexa, lost patent protection. Zyprexa, which is approved to treat schizophrenia and bipolar disorder, once had sales of more than $5 billion per year.
Earlier this year Lilly lost patent protection for Humalog, an insulin injection for diabetics, which had sales of $2.4 billion in 2012.