BRIDGEWATER, N.J. — The Food and Drug Administration has approved a number of applications for the generic version of Pfizer’s Lyrica (pregabalin). The FDA gave the green light to the following companies: Amneal, Alembic, Alkem, Dr. Reddy’s, InvaGen, MSN Laboratories, Rising Pharmaceuticals, Sciegen, and Teva.
Amneal’s generic version of Lyrica (pregabalin capsules) will be available in 25 mg, 50 mg, 75, mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg. The company has now launched 21 generic products in 2019.
“This new generic launch provides an important treatment option for patients and, as our twenty-first generic product launch this year, demonstrates the continued momentum of our generic pipeline,” said Rob Stewart, president and chief executive officer of Amneal. “We expect this momentum to continue throughout the remainder of 2019 as we work toward making up to 50 new generic products available to patients in the U.S.”
According to IQVIATM, U.S. market annual sales for the 12 months ended May 31, 2019 for pregabalin capsules was estimated to be approximately $5.4 billion.