2018 U.S. sales: $3.5 billion
Disease: Nerve pain and fibromyalgia
Patent expiration: June 30
First approved in 2004, Pfizer’s Lyrica has had quite a run—but now it's coming to an end. After generating $3.5 billion in the U.S. last year, the drug is set to face a generics onslaught midyear.
Since it was first approved by the FDA, the drug has pulled in more than $30 billion in the U.S., according to data provided by life science commercial intelligence firm Evaluate. But while the patent loss will bring financial hurt for Pfizer—on top of the Viagra generics hit that began at the end of 2017—there's a silver lining. Lyrica's patent cliff is the last major expiration for the company in the next few years, CEO Albert Bourla told an audience at the J.P. Morgan Healthcare Conference in January.
That's lucky for the new CEO. Bourla's predecessor, Ian Read, took the reins as Pfizer faced an unprecedented patent cliff: The company lost about $10 billion in sales in just a few years, he said. After Lyrica's generic downfall this year, it'll be 2026 before any significant drugs face copycats.
And meanwhile, the company has several potential blockbusters coming up the pipeline that could help it grow past the Lyrica patent expiration, executives said at the J.P. Morgan conference. Among them is pain candidate tanezumab, part of a partnership with Eli Lilly.
Used to treat nerve pain and fibromyalgia, Lyrica was originally set to lose exclusivity at the end of 2018. But Pfizer scored an additional 6 months of exclusivity from the FDA after testing the drug in pediatric patients. Now, Teva, Mylan, Sandoz and many other generic companies have tentative approvals ready to roll, according to the FDA.
Even as Pfizer is facing a multibillion-dollar loss to revenues in the U.S., the company is actually challenging top biologics brands with its biosimilars portfolio. The drugmaker launched the first biosim to Johnson & Johnson’s Remicade and last year rolled out a biosim to Procrit and Epogen called Retacrit. Beyond those marketed drugs, the company has four “high-value biosimilars” with potential approvals this year, R&D head Mikael Dolsten, M.D., Ph.D., said at J.P. Morgan.
And while the U.S. biosimilars environment continues to take shape, Pfizer has played an active role in helping biosims gain share against entrenched biologics. The company sued Johnson & Johnson for "anticompetitive" contracting to protect Remicade and filed an FDA petition with complaints over how branded drug companies "mislead" with their communications about biosimilars.