FDA approves nine companies for first generics of Lyrica

The nine companies are based mostly in the US and India with one located in Israel

The FDA in the US has approved multiple applications for first generics of Lyrica (pregabalin). The FDA granted approvals to nine different companies from the US, India and Israel.

Northwestern University developed pregabalin and holds a patent on it, exclusively licensing to Pfizer. That patent, along with others, was challenged by generic manufacturers and was upheld in 2014, giving Pfizer exclusivity for Lyrica in the US until 2018.

Now the FDA has granted approvals for the generic versions of Lyrica to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.

The substance is used 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.

“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.”

Pregabalin must be dispensed with a patient Medication Guide that contains important information about its uses and risks. Warnings include the risk of many potential side effects.

Companies