Pharmacy | July 24, 2019

FDA Approves Generic Lyrica® Pregabalin

One of the most talked-about drug patents in workers’ compensation, Pfizer’s Lyrica® (pregabalin), patent extensions ended on July 1, 2019. 

Lyrica (pregabalin) is one of the most commonly prescribed drugs for neuropathic pain. The drug was first approved for use in 2004 and has since seen several patent extensions. Lyrica was the 15th top selling drug of 2018, with sales totaling $4.97 billion.

On July 19, 2019, the FDA gave nine manufacturers the ability to market different strengths of pregabalin. Mitchell anticipates these versions of pregabalin will push prices down. The FDA noted, “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.” (FDA)

Approvals went to: Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals Inc., and Teva Pharmaceuticals.

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