Lyrica generics roll: Pfizer blockbuster finally hits patent cliff

Since its U.S. approval in 2004, Pfizer’s Lyrica has churned out billions and climbed to the top of the company's pharma sales charts. But now its patent cliff is here.

The FDA approved copycats from 10 drugmakers on Friday, officially putting Pfizer's megablockbuster—and its $3.6 billion in U.S. sales last year—on notice. When its previous top-seller, Lipitor, went off patent in 2011, those sales plummeted by 90% within a year.

But there's one silver lining to Lyrica's fall. The drug is Pfizer's main patent expiration through 2026, CEO Albert Bourla said early this year, and that gives the company years to build up the brand's successors.

Bourla's predecessor Ian Read took the reins at Pfizer ahead of numerous patent losses, Bourla said at the J.P. Morgan Healthcare Conference in January, but after Lyrica’s patent cliff, “we have a virtual LOE-free period until 2026,” he said.

Meanwhile, the company has a strong pipeline and several launch prospects to propel it forward in the years to come, he said. Bourla took on the Pfizer CEO post at the start of this year.

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Lyrica copycats from Albemic, Alkem Laboratories, Amneal, Dr. Reddy's Laboratories, InvaGen, MSN Laboratories, Rising Pharmaceuticals, Sciegen and Teva will be aiming to grab sales away from Pfizer, thanks to approvals the FDA announced Monday.

All of the approvals are part of the FDA's "longstanding commitment to advance patient access to lower-cost, high-quality generic medicines," director of the FDA's Center for Drug Evaluation and Research Janet Woodcock said in a statement.

FDA numbers show generic prices run about one-quarter the brand when 10 copycat drugmakers are fighting for share.

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Last November, Pfizer scored a six-month exclusivity extension for Lyrica until the end of June thanks to tests it ran in pediatric patients.  

The fact that numerous generics companies are launching at the same time will likely mean a sharper sales dropoff for Lyrica. If only one competitor reached the market, sales might have only dropped slightly to start. But other generic drugmakers are surely eying the multibillion-dollar market, indicating Lyrica’s days atop Pfizer sales charts are likely over.