First generics to Bristol-Myers and Pfizer's Eliquis are here. But can they launch before 2026?

Blood thinner Eliquis has been a major growth driver for Bristol-Myers Squibb and partner Pfizer, as well as the overall biopharma sector. Now, though, the blockbuster earner might face some cheaper company.

The FDA approved the first two copycats to Eliquis, made by Mylan and Micro Labs, on Christmas Eve. But despite the agency's announcement, which touted its efforts to get generics to market, the Eliquis copies will not get there anytime soon.

In an ongoing patent dispute, Bristol is strenuously defending the drug. And no wonder—Bristol and Pfizer each have a lot at stake with Eliquis. Billions, in fact.

As Bristol's best-selling drug before the Celgene merger—even ahead of PD-1 inhibitor Opdivo—the drug delivered $5.9 billion to the company’s top line in the first nine months of 2019. Its 25% year-over-year growth rate during the period also far exceeded Opdivo’s 10%.

As for Pfizer, Eliquis delivered a total of $3.1 billion in the first nine months, mostly in revenue from its Bristol alliance but some via direct sales in smaller markets.

In 2017, 25 generics companies told Bristol that they had filed for FDA approval of their copycats. The pair soon erected a patent wall, launching lawsuits against all those drugmakers.

That August, the U.S. Patent and Trademark Office granted Eliquis a key composition of matter patent, extending it from February 2023 to November 2026. Bristol and Pfizer have argued that’s when Eliquis generics can enter.

While the pair has reached settlements with several generics players that “do not affect the company’s projected [loss of exclusivity] for Eliquis,” some others haven’t backed down, according to Bristol’s most recent quarterly securities filing. A Bristol spokesperson confirmed to FiercePharma that the company has settlement agreements with Mylan and Micro Labs.

RELATED: Pfizer, BMS look to early atrial fibrillation screening for potential Eliquis boost

Eliquis is currently ahead in the novel oral anticoagulants (NOACs) market, which also includes Johnson & Johnson and Bayer’s Xarelto and Boehringer Ingelheim’s Pradaxa.

Xarelto hauled in €2.98 billion ($3.31 billion)—including license revenues—for Bayer in the first nine months, up 13%. Johnson & Johnson, which sells the drug only in the U.S., recorded a sales decline of 9% to $1.7 billion during the three quarters as the company tries to work past the Medicare doughnut hole.

Even though Xarelto’s third-quarter U.S. sales finally stabilized compared with last year, it was no match to Eliquis’ 22% growth worldwide. Eliquis’ scripts jumped 30% year over year, making it the clear leader in the NOAC class, Bristol Chief Financial Officer Charles Bancroft said on a conference call in October.

RELATED: BMS and Pfizer file 16 Eliquis patent lawsuits to waylay generic makers

According to Evaluate Pharma’s 2020 Preview report published in December, Eliquis ranks as the No.4 biggest new sales generator, with a projected sales increase of $1.08 billion in 2020.

Bristol recently headed into trial against those Eliquis generics drugmakers in the U.S. District Court for the District of Delaware. When asked by Wolfe Pharma’s Tim Anderson, CEO Giovanni Caforio “denied that any part of the Celgene transaction was to hedge against a potential adverse ruling,” the analyst wrote in a November investor note.

Editor's Note: The story has been updated to reflect that Bristol-Myers Squibb has reached settlements with Mylan and Micro Labs.