Merck pulls a patent win for diabetes franchise in West Virginia federal court
Merck doesn’t have to sweat Januvia and Janumet competitors — at least for now.
A federal judge awarded Merck a win in its patent battle against Viatris, the pharma giant announced Thursday, putting the freeze on a potential Viatris generic until at least 2026, barring an appeal.
Judge Irene Keeley of West Virginia upheld two key patents surrounding sitagliptin, an active ingredient in the blockbuster diabetes drugs. The first patent, No. 7,326,708, covers the dihydrogen phosphate salt of sitagliptin and is valid through 2026, with pediatric exclusivity until 2027. The second, No. 8,414,921, covers the co-formulation of sitagliptin and metformin in Janumet and expires in 2029.
While it isn’t immediately clear if Viatris will challenge the decision, the company has fought Merck’s diabetes patents in the past and is currently in a separate appeals case over the validity of the salt patent. Viatris is looking to go to market with generics for both Januvia and Janumet, which together raked in $1.2 billion last quarter, up 3% from Q2 2021. Last year, the drugs earned more than $5.2 billion. Viatris did not respond to a request for comment as of press time.
Januvia and Janumet are oral drugs designed to lower blood sugar, but Janumet also contains metformin, which helps the body respond better to insulin.
Merck has settled with several other rivals who have agreed not to launch their own generics until 2026 “or earlier under certain circumstances,” the company said in a news release. The company has previously said it expects sales in the US “will decline significantly” once generics reach the market.
While Januvia was originally set to lose patent exclusivity next year, Merck noted that if the salt patent was found to be valid, certain rights could be extended to 2027.
Just last month, regulators announced that they discovered a nitrosamine impurity in some Januvia samples but allowed the temporary distribution of samples containing the impurity above acceptable levels to avoid a shortage of the drug.
“It could be dangerous for patients with this condition to stop taking their sitagliptin without first talking to their health care professional. FDA recommends prescribers continue to use sitagliptin when clinically appropriate to prevent a gap in patient treatment,” the agency said.