2020 U.S. sales: $223 million
Disease: gastrointestinal stromal tumors, advanced renal cell carcinoma and pancreatic neuroendocrine tumors
Potential generic entry: August 2021
As Pfizer grabbed headlines in 2020 for winning the COVID-19 vaccine race, investors were not so focused on the company's core research priorities, including oncology. But as life after COVID comes into view, it's hard to overlook one big patent loss Pfizer is facing this year in cancer.
Sutent, approved in 2006, is used to treat certain patients with gastrointestinal stromal tumors, advanced renal cell carcinoma (RCC) and certain pancreatic neuroendocrine tumors. All of the medicine’s patents expire in 2021, leaving it vulnerable to generics rivals, though so far no copycats have received FDA approvals, according to agency records.
Glenmark just launched a Sutent generic in India. Mylan submitted its Sutent generic to the FDA in 2010, prompting Pfizer to sue alleging patent infringement. After a four-day trial in 2014, the court upheld Sutent's 2021 patents.
“Defending our intellectual property is crucial to our ability to discover and develop innovative new medicines, which is at the very core of what we do,” Pfizer’s general counsel Douglas Lankler said at the time.
Years after that patent dispute, Mylan and Pfizer teamed up to combine Pfizer's Upjohn unit with Mylan and form a new company, Viatris. The deal closed last November.
The status of Sutent generics in the U.S. is unclear. Glenmark didn't respond to a request for comment by press time, and Viatris declined to comment.
Sutent generated $223 million in the U.S. last year, a 21% decrease from the prior year. Sutent’s sales are actually much higher around the globe, reaching nearly $600 million last year, so Pfizer could continue to see a meaningful contribution from the medicine after its U.S. loss of exclusivity. The drug earns its largest share of sales from emerging markets, where it generated $261 million in 2020.
Sutent has “long been a standard of care for the treatment of advanced RCC, and has reached more than 250,000 patients across diagnoses around the world since its initial approval 10 years ago,” Pfizer’s Chief Medical Officer Mace Rothenberg said in a 2016 statement.