AstraZeneca staves off last Tagrisso copycat with settlement—for now

As copycat drugmakers circle the gates, AstraZeneca has won a reprieve for lung cancer cash cow Tagrisso—for now.

AstraZeneca has settled its patent infringement suit with Alembic Pharmaceuticals—the last of three generic holdouts—according to court documents filed Monday. Alembic is now blocked from making, selling or distributing its Tagrisso knock-off until the branded med’s intellectual property protection runs out in the next decade “[e]xcept as specifically authorized,” documents filed Monday in the U.S. District Court for Delaware show. 

The court documents didn't lay out the specifics of when Alembic may be able to launch under those settlement exceptions.

The case stems back to February 2020, when AstraZeneca called infringement on multiple generics outfits and filed lawsuits in the Delaware court. AstraZeneca argued a marketed Tagrisso generic would violate the med’s intellectual property protections as laid out in the FDA orange book, which shows Tagrisso patents stretching into the mid-2030s.

Late last year, AstraZeneca settled similar cases with Zydus Pharmaceuticals and Cadila Healthcare, plus MSN Laboratories and MSN Pharmaceuticals. With the Alembic settlement in the books, AstraZeneca has warded off the last of three generic challengers to its lucrative lung cancer med.

That's good news for the British drugmaker, whose Tagrisso generated $1.78 billion in the U.S. in 2021—5% of AZ’s total revenue for the year.

But that doesn’t mean the drug—or the company—is in the clear altogether.

While AZ went on the attack against Alembic, Zydus and MSN, the British drugmaker could soon be battling over Tagrisso patents from the opposite front. That’s because Puma Biotechnology and Pfizer’s Wyeth in September filed their own Tagrisso infringement lawsuit against AstraZeneca.

In their suit, the companies said AstraZeneca and its subsidiaries are infringing their patents. They're seeking a financial payout and a court order blocking AstraZeneca’s Tagrisso sales. The trial date and case schedule weren't set as of AstraZeneca's 2021 annual report, published in late February.