The agreement ends a case that was scheduled to begin trial May 12 in federal court in Newark, New Jersey. Merck had sought to prevent Glenmark from entering the market until a patent expires April 25, 2017. The settlement lets Mumbai-based Glenmark enter the market Dec. 12, 2016, or earlier “under certain circumstances,” Merck said in a statement today.
U.S. sales of Zetia were $1.3 billion last year, said Ronald Rogers, a spokesman for Whitehouse Station, New Jersey- based Merck. Zetia, whose chemical name is ezetimibe, has been on the market since 2002.
Ezetimibe also is a key ingredient in Merck’s Vytorin cholesterol drug, which combines Zetia with simvastatin, the active ingredient in Merck’s Zocor. Teva Pharmaceutical Industries Ltd., the world’s biggest generic-drug maker, and Mylan Inc. are challenging the patent as part of their efforts to sell a generic version of Vytorin.
“We continue to believe the patent for Zetia is valid and enforceable and we will vigorously defend against those challenges,” Rogers said.
Merck had marketed the drugs with Schering-Plough Corp. before buying the company last year.
Par Pharmaceutical Cos., based in Woodcliff Lake, New Jersey, said it had bought exclusive rights to sell the generic version of Zetia in the U.S. from Glenmark. The companies will share in profits, Par said in a statement today.
UnitedHealth Group Inc., the biggest U.S. health insurer by sales, said last month it’s doubling the amount it will charge most customers for Zetia and Vytorin to deter patients from using the medicine. Vytorin didn’t work significantly better than simvastatin at keeping patients out of the hospital for heart attacks or stroke, according to an analysis of 30,000 patients by UnitedHealth released in November.
The case is Schering Corp. v. Glenmark Pharmaceuticals Inc., 07cv1334, U.S. District Court for the District of New Jersey (Newark).