FDA Approves Generic for Lyrica
May 19, 2024

The U.S. Food and Drug Administration (FDA) approved multiple applications for the first generic version of Lyrica for managing neuropathic pain. It approved nine generic versions of Lyrica. Beyond treating pain, the drug is used to treat seizures and fibromyalgia, a condition that causes chronic pain.

In workers’ comp, Lyrica, pregabalin, is commonly used for treating neuropathic pain conditions and is often included on formularies. It is one of the more expensive drugs by spend for workers’ comp payers, so with a less-expensive option payers may expect a decrease in spend. This drug is also typical in workers’ compensation Medicare Set-Asides so payers may expect an impact on MSA allocations.

Lyrica is very expensive, costing between $460 to $720 a month without insurance but prices can vary significantly. It is Pfizer’s second bestseller, with sales of $4.6 billion last year. The prices for generic versions are expected to range from $140 to $370 a month.

Last year there was a six-month delay on the announcement of the FDA’s approval.

“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,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”

Common side effects reported for Lyrica are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain and abnormal thinking (mostly difficulty with concentration and attention).

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