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Regulatory Focus™ > News Articles > 2019 > 7 > FDA Approves First Lyrica Generics From 9 Sponsors

FDA Approves First Lyrica Generics From 9 Sponsors

Posted 22 July 2019 | By Zachary Brennan 

FDA Approves First Lyrica Generics From 9 Sponsors

The US Food and Drug Administration (FDA) on Friday approved the first generic versions of Pfizer’s blockbuster pain drug Lyrica (pregabalin).

The approvals were granted to Alembic Pharmaceuticals, Alkem Laboratories, Amneal Pharmaceuticals, Dr. Reddy’s Laboratories, InvaGen Pharmaceuticals, MSN Laboratories, Rising Pharmaceuticals, Sciegen Pharmaceuticals and Teva Pharmaceuticals.

“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 Center for Drug Evaluation and Research Director Janet Woodcock.

On the market since 2004, Lyrica was singled out by the generic industry’s Association of Accessible Medicines (AAM) as an example of patent abuse. AAM said Pfizer filed 118 patent applications and had 68 patents issued, with the drug’s price rising more than 163% since 2012.

Last December, Sen. Ron Wyden (D-OR) sent a letter to Pfizer seeking to know why Lyrica’s price had increased by 145% between 2009 and 2015.

And generic versions of the drug would have come to the US sooner if Pfizer had not won an extra six months of pediatric exclusivity last November. Pfizer pulled in about $5 billion in worldwide revenue from Lyrica in 2018, $5.1 billion in 2017 and about $5 billion in 2016.



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