FDA greenlights nine Lyrica generics

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/greenleaf123)
(Image: Getty/greenleaf123)

Related tags: Lyrica, Fda, FDA approval, Pfizer, Amneal Pharmaceuticals, Teva

Nine companies, including Teva, Alembic and Amneal receive US FDA approval for generic versions of Pfizer’s blockbuster Lyrica.

Lyrica (pregabalin), a treatment for epilepsy and neuropathic pain, has a current estimated market size of $5.47bn (€4.9bn), according to analysis by IQVIA​.

The US Food and Drug Administration (FDA) has approved nine companies to commercialize generic versions of the drug, including Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories Ltd., Rising Pharmaceuticals, Sciegen Pharmaceuticals, and Teva Pharmaceuticals.

Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia.

It can also be prescribed 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 neuropathic pain associated with spinal cord injury.

Pfizer patent protection for the treatment has already fallen in Europe, after it lost a case at the UK Supreme Court in November 2018​.

Regarding the US market, the company was granted an additional six-month paediatric exclusivity for Lyrica from the US FDA in December 2018, which expired on June 30, 2019.

Pfizer CFO, Frank D'Amelio, has previously referred to the company’s future for growth as pre- and post-loss of exclusivity for Lyrica.

Rising competition, lowering prices

While announcing the green light for the nine companies to enter the Lyrica market, Janet Woodcock, director of the FDA’s center for drug evaluation and research, said that this is expected to “advance patient access to lower cost, high-quality generic medicines.”

“Efficiently bringing safe and effective generics to market so patients have more options to treat their conditions is a top priority for the FDA,” ​Woodcock commented, highlighting the need to promote more generic competition and patient access to more affordable medicines.

The FDA has publicly stated​ that it is aiming to increase generic competition and has proceeded​ with the approvals of various generic drugs.

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