Drug Approvals

Pfizer’s Lyrica officially drops off the patent cliff

Jul 22, 2019

It was great while it lasted. But Pfizer’s blockbuster drug, Lyrica, is now officially facing generics competition.

This week the FDA announced that it has approved generic versions of Lyrica to nine different companies including Teva Pharmaceuticals, Dr. Reddy’s Laboratories and Amneal Pharmaceuticals. The generic versions were approved to treat numerous indications including neuropathic pain associated with diabetic peripheral neuropathy, fibromyalgia, partial onset seizures and spinal cord injury pain.

Lyrica (pregabalin) was first approved in 2004. By 2008, it hit blockbuster status and eventually became Pfizer’s best-selling drug. Last year, Lyrica pulled in nearly $5 billion in global sales.

Lyrica was set to fall off the patent cliff in 2018, but Pfizer managed to win a six month patent extension, giving the company a little breathing room as it works on other ways to produce major revenue-generators. For example, in June, the company announced that it is buying Array Biopharma for about $10 billion to help bolster its portfolio of oncology drugs.

Because so many generic versions of Lyrica will be hitting the market in the same year, Lyrica sales are expected to plummet. In April, the company warned that it expects to “enter a period of significantly reduced revenue.” By comparison, when Pfizer’s Lipitor, another top-selling drug, went off patent in 2011, sales tanked by 90 percent.

Read the full FDA press release.

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