- A Delaware district court judge has upheld two key patents covering Bristol Myers Squibb and Pfizer's blockbuster blood-thinning drug Eliquis.
- The judge ruled that generic versions of Eliquis from Sigmapharm, Sunshine Lake and Unichem infringe on composition of matter and formulation patents. Pending the outcome of any potential appeal, the companies wouldn't be able to launch copycat versions of the anticoagulant until 2031.
- Through previous settlements with other drugmakers, generic forms of Eliquis could still hit the market as early as 2026. But the ruling is nonetheless a significant victory for both companies, which share Eliquis sales through a 2007 alliance — particularly for Bristol Myers, for which the drug is a critical revenue driver.
Since its approval in 2012, Eliquis has become one of the top-selling drugs in the world. The pill is used to reduce the risk of clots and strokes in people with various heart problems, and its sales have grown by at least $1 billion each year since 2014.
With $7.9 billion in sales in 2019, Eliquis is the top drug of its kind, pacing other rivals like Bayer and Johnson & Johnson's Xarelto. Already in 2020, sales have totaled $4.8 billion.
While Pfizer and Bristol Myers share in those profits, the drug is especially important for Bristol Myers since its cancer immunotherapy franchise has fallen behind Merck & Co.'s in recent years. The company is now relying on its recent, expensive acquisition of Celgene for new sources of growth.
That deal, one of the largest ever struck in the industry, resulted in significant new debt for the combined company — debt that Bristol Myers needs cash to help pay down. Celgene's Revlimid and Bristol Myers Opdivo will provide much of that financial cushion, but Eliquis plays a role as well.
The drug, which has three patents covering it that expire in 2026 and 2031, accounted for 23% of the company's revenue over the first six months of this year. As of June 30, total debt for Bristol Myers stood at $46.7 billion.
An early generic entry against Eliquis, then, would be an issue for Bristol Myers. At least thus far, it's been able to delay their launch. In 2019 the FDA approved a couple of copycat versions of Eliquis from Mylan and Micro Labs. But Bristol Myers struck settlements with each, pushing the launch of their products back to at least 2026.
The latest challenge came from Sigmapharm, Sunshine Lake and Unichem. The victory in that suit late Wednesday means that, unless the companies win an appeal, they can't launch a generic Eliquis until 2031. Bristol Myers and Pfizer currently expect generics to arrive "after 2026 but before 2031, subject to appeals and future challenges."
Bristol Myers shares rose by as much as 6% after the news broke late Wednesday, before further trading pared back that gain to around 5.3%. Pfizer shares ticked up about 1.4%.