Pfizer, looking to protect billions in Lyrica sales, has been gunning for a 6-month pediatric exclusivity extension for its top drug. And on Tuesday, the FDA came through in favor of the drugmaker.
Lyrica won extra exclusivity after Pfizer tested its drug in patients with pediatric epilepsy; the drug succeeded in a phase 3 trial in the patient group back in May. Along with its indications to treat fibromyalgia and pain from certain causes, Lyrica is also approved as an adjunctive therapy to treat partial onset seizures in patients four years and older.
The drug's patent shield was set to expire at the end of the year, but its protections will now run through June 30, 2019. Last year, Lyrica pulled in nearly $3.5 billion in the U.S., and the patent extension should allow Pfizer to protect about half of that figure next year.
Lyrica is the company’s bestselling medicine, raking in more than $5 billion in sales globally last year. Among all of Pfizer’s products, it trailed only pneumococcal vaccine Prevnar 13 in sales. Lyrica won its initial approval in 2004.
Pfizer executives had been counting on the six months of extra exclusivity as the company positions itself to move past patent expirations and shoot for growth from new drugs. The company also recently lost exclusivity on erectile dysfunction med Viagra.
Looking forward, Pfizer has several launches to help fill the gap from new generics. Most recently, the company won FDA approval for acute myeloid leukemia drug Daurismo in certain patients 75 and older. Before that, it also secured FDA nods for targeted lung cancer drug Vizimpro, plus Talzenna in breast cancer and Lorbrena in non-small cell lung cancer.
But amid Pfizer’s recent wins at the FDA, the company also lost a patent fight in the U.K. that could end up costing it significantly. The U.K. Supreme Court recently ruled that Lyrica’s neuropathic pain patent claims were invalid after a several-year dispute, and the decision could allow NHS England to seek to recoup £502 million in overspending. A spokesperson for the agency said NHS England is deciding on next steps.