Pfizer has recalled more than half a million vials of Protonix, its injected gastrointestinal med that has been distinguished in recent years by the litigation surrounding it.
The New York drugmaker actually initiated the voluntary recall in November because of a possibility the proton-pump inhibitor might be subpotent, but the FDA only last week deemed it a class III recall. Pfizer recalled 8 lots of Protonix, comprising 582,165 vials.
A month later, India’s Aurobindo recalled 29,800 vials of its generics version of the drug.
While there are generics of Protonix on the market now, there weren’t in 2007 when Teva and Sun Pharma took a chance and launched their at-risk generics of the med. They were taking a chance they could win a patent challenge against the drug's then-marketer Wyeth. It was no-go, however, when in 2010 a jury nixed that possibility with the decision that the Protonix patent was valid, leaving the two on the hook for big bucks.
Pfizer and Takeda, which shared Protonix, in 2013, reached a $2.15 billion settlement over infringement on the 2011 patent for the acid reflux medication, with Sun shouldering about $550 million of the cost.
Then last year, Pfizer had to turn around and pay out $786 million in a settlement with the Justice Department to get beyond claims that Wyeth overcharged Medicaid for the heartburn med. Pfizer inherited the case with acquisition of Wyeth in 2009.