First Generics of Lyrica Receive FDA Approval

On July 19th, the FDA issued a press release announcing the approval of generic versions of the drug Lyrica (pregabalin). When Lyrica received initial approval by the FDA back in 2004, it was indicated for neuropathic pain associated with diabetic peripheral neuropathy. Since then, Lyrica has been indicated for a wide range of off-label uses, including for the management of postherpetic neuralgia, as an adjunctive therapy for adult patients with partial onset seizures, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury. In addition, there’s been an increase in the inclusion rate of Lyrica in WCMSAs for the treatment of low back pain and radiculopathy.

The FDA granted approvals for the generic versions of Lyrica to nine manufacturers: Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Inc., Sciegen Pharmaceuticals and Teva Pharmaceuticals. This competition among manufacturers entering the market will likely lead to lower prices and thereby advance patient access to more affordable versions of this medication. There is usually a lag time between approval and availability, as it is the discretion of the manufacturing company as to when they will begin to distribute the generic products and this can take anywhere from a few weeks to several months. We will continue to monitor the status of availability and post updates as they become available.