As a top-selling drug worldwide, Pfizer and Bristol Myers Squibb’s Eliquis is a major target for generic players looking to steal branded sales. But with a new court win, the partners are set for many more years of exclusivity in the lucrative U.S. market.
The U.S. Court of Appeals for the Federal Circuit has upheld a prior win for the companies covering two Eliquis patents—the drug’s composition of matter patent and a formulation patent. While the case is subject to another potential appeal, this appeals win sets the companies up to retain U.S. exclusivity until April 1, 2028.
Previously, the companies had expected generics of the anticoagulant to enter the U.S. market between 2026 and 2031. The company has settled with a number of generic companies, but Sigmapharm, Sunshine Lake Pharma, Hec Pharm and Unichem opted to take their arguments to court.
In a court ruling last summer, the U.S. District Court for the District of Delaware found that the two patents at question were valid. The generic companies appealed, leading to last week’s ruling.
Given that Eliquis is among the world’s bestselling medicines, generating about $9 billion per year, those extra years of U.S. patent protections will likely mean billions in revenues for the Big Pharma partners.
While the FDA has already approved some Eliquis copycats, those versions won’t reach the market until settlement terms are met or until the drug’s patent protections run out.
Despite the pandemic, Eliquis generated $9.17 billion in 2020, a 16% increase from 2019. In the long run, the company believes the “growth outlook for Eliquis remains strong as we continue to grow the oral anticoagulant class” and as BMS bolsters its share within the class, Bristol Myers CFO David Elkins said earlier this year.
Pfizer and BMS entered their global partnership on the medicine way back in 2007. BMS originally developed the oral anticoagulant, also known as apixaban, and brought Pfizer into the fray for its “global scale and expertise” in the treatment area.