WASHINGTON – The Food and Drug Administration has approved the first generic versions of the blockbuster antidepressant Cymbalta, offering lower-cost access to one of the most widely prescribed treatments for depression, anxiety and other disorders.
Cymbalta is Eli Lilly & Co. Inc.’s bestselling drug and posted 2012 sales of $4.7 billion, making it the fifth-highest selling medication in the world. The drug’s patent expired Wednesday, clearing the way for the launch of cheaper versions of the drug from generic drugmakers. Generic drugs often sell for a fraction of the price of the original branded product.
Besides depression, Cymbalta is also prescribed to treat generalized anxiety disorder, diabetic nerve pain, fibromyalgia and forms of chronic pain.
The FDA said it approved six generic versions of the pill from drugmakers including Dr. Reddy’s Laboratories Ltd., Sun Pharma Global and Teva Pharmaceuticals.
The loss of Cymbalta is the latest in a series of patent expirations that have battered Indianapolis-based Lilly’s balance sheet in recent years. Revenue has been under pressure since 2011, when the company’s all-time best selling drug, the antipsychotic Zyprexa, lost U.S. patent protection. That drug, approved to treat schizophrenia and bipolar disorder, once had global sales of over $5 billion per year.
Earlier this year the company also lost U.S. patent protection for its bestselling insulin injection for diabetics, Humalog, which had 2012 sales of $2.4 billion.
Lilly has said it will counter the revenue loss from the patent expirations by developing new drugs, cutting costs and depending on sales in foreign markets and developing countries.