Posted from: Friday, August 09, 2019 - 03:14 PM - Present

First Generics for Lyrica Approved

July 22, 2019 – The U.S. FDA has approved the first generic versions of Pfizer’s Lyrica® (pregabalin). Pregabalin is indicated to manage fibromyalgia, postherpetic neuralgia, and neuropathic pain associated with diabetic peripheral neuropathy or with spinal cord injury, as well as for use as adjunct therapy for partial onset seizures in patients 17 years of age and older.

Approval for the generics was granted 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. Generic versions of all eight capsule dosage strengths – 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg, and 300mg – will be available.

Recommended dosing is determined by the indication. If being used for the treatment of partial onset seizures, Lyrica should be dosed based on the patient’s weight. Should the patient and prescriber decide to stop treatment with Lyrica, its use should be tapered off gradually over the course of at least one week.

Originally approved in 2004, Lyrica is also available in other dosage forms. Patents on the oral solution have expired, with generics anticipated in the near future. A controlled-release version, Lyrica CR, remains under patent protection.

The new Lyrica generics have launched at an average wholesale price (AWP) of approximately $654.16 for 90 capsules, depending on manufacturer and dose, versus approximately $842.74 for the brand name.

Last Updated Friday, October 18, 2019 - 12:34 AM.