FDA opens flood gates for Lyrica generics

The US Food and Drug Administration today announced that, on July 19, it approved multiple applications for first generics of Lyrica (pregabalin), thus opening the flood gates for competition to Pfizer’s (NYSE: PFE) blockbuster treatment.

Lyrica, the patent on which expired on December 30, 2018, is approved for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury.

According to IQVIA, Lyrica, Pfizer’s best-selling medicine, had US sales of around $5.4 billion for the 12-month period ending March 2019.