Everything is coming up roses for Merck in its patent battle with India's Glenmark Pharmaceuticals over copycats of the drugmaker's diabetes meds Januvia and Janumet, as the Delhi High Court barred the generics company from selling cheap knockoff versions of the drugs in the country.
LONDON-- Late last month, partners Eli Lilly and Boehringer Ingelheim announced that their SGLT2 diabetes med, Jardiance, had gone where no others had gone before. While its rivals had always either increased the risk of cardiovascular events or, at best, had no effect, the newcomer showed it could actually lower the risk of heart attack, stroke and death from cardiovascular causes.
As if last week's Jardiance news wasn't enough to worry makers of DPP-4 diabetes drugs, the FDA has now issued a warning that the class of meds might cause "severe and disabling" joint pain.
The good news keeps rolling in for Merck when it comes to the cardiovascular safety of its DPP-4 inhibitor, Januvia. According to a new analysis of the TECOS trial, patients with Type 2 diabetes and cardiovascular disease--even those with a history of heart failure--can take the drug without an increased risk of CV complications.
Merck's Januvia has seen its fair share of competition from generics makers and other diabetes challengers. But now, it could face a new rival on the scene--and it's a device.
Merck & Co. has encountered a few roadblocks in recent years with its diabetes drug, Januvia as safety concerns took a bite out of sales. The company has worked hard to reverse this trend, and recently unveiled data on heart safety could do its part. But now Merck could be facing another threat, and not from a regulator or competing drugmaker--but a devicemaker.
Some industry watchers are wondering whether those large, expensive trials--which aren't long enough to establish long-term outcomes--were worth it.
Merck scored a victory in its patent battle with India's Glenmark Pharmaceuticals over copycats of the drugmaker's diabetes meds Januvia and Janumet, as India's highest court blocked the generics company from marketing its cheap versions of the drugs in the country.
Glenmark's marketing of a couple of diabetes generics in the United States continues to fluctuate like a yo-yo on a string. Now the India drugmaker can return the drugs to market until April 28.
India's highest court has granted an injunction against Glenmark Pharmaceuticals, blocking it from producing and marketing a generic of Merck's Januvia (sitagliptin) for treating diabetes. A patent-infringement suit was not affected by the decision.