FDA Approves First Generic Versions of Fibromyalgia Drug Lyrica

On Monday, the U.S. Food and Drug Administration (FDA) announced it approved several generic versions of the brand name drug Lyrica (pregabalin). Used to manage fibromyalgia symptoms and other neuropathic pain conditions, this news could mean big savings on your drug costs.

• What is Fibromyalgia?
• What Are Common Fibromyalgia Symptoms?

Lyrica was first approved by the FDA in 2004. It’s approved to treat diabetic peripheral neuropathy, postherpetic neuralgia, partial onset seizures after age 4 and fibromyalgia symptoms. Its patent was set to expire at the end of 2018. The drug’s manufacturer, Pfizer, gained a six-month patent extension after a successful trial showed the medication was effective in treating pediatric epilepsy, according to FiercePharma. Pfizer’s patent ended June 30.

Lyrica is one of only three drugs approved to treat fibromyalgia by the FDA, along with duloxetine (brand name Cymbalta) and milnacipran (brand name Savella). Duloxetine was already available as a generic but Savella is not. Generics are typically significantly cheaper than brand name drugs still protected by a patent. For example, generic duloxetine currently costs approximately $6 compared to about $250 for the brand name version, according to GoodRX. Lyrica, as a brand name, currently costs an estimated $573 per month.

Nine new drug companies are now allowed to sell generic pregabalin. In order to be approved, the generic versions of the drug must be biologically equivalent to the brand, meaning they should work exactly the same. An FDA press release announcing the news said this latest generic approval is part of the FDA’s Drug Competition Action Plan designed to lower drug costs for patients.

“Today’s approval of the first generics for pregabalin, a widely-used medication, is another example of the FDA’s longstanding commitment to advance patient access to lower cost, high-quality generic medicines,” Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “The FDA requires that generic drugs meet rigorous scientific and quality standards. Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA.”

It’s unclear how soon generic pregabalin (Lyrica) will be available for consumers. A press release from one of the companies approved to sell the generic medication, Amneal Pharmaceuticals, said it already launched its drug.

If you’re prescribed Lyrica and want to know if you can get the generic version now, talk with your doctor.