New Delhi: Glenmark Pharmaceuticals on Tuesday said it has settled a patent litigation with Merck & Co over its cholesterol lowering generic drug ‘Ezetimibe´, following which the firm can sell the medicine in the US market.
Ezetimibe is a generic version of Merck-Schering Plough’s patented drug ‘Zetia’.
Glenmark and Merck were fighting a patent litigation in the US court after the Indian firm had filed Abbreviated New Drug Application with first-to-file status that entitled it a potential of 180 days of marketing exclusivity in the US.
“Under the agreement, Glenmark will be able to launch its product on 12 December, 2016, or earlier under certain circumstances, ahead of the 25 April, 2017 expiration of Merck’s patent exclusivity for Zetia,” the company said in a statement.
This settlement effectively ends the lawsuit involving a challenge by Glenmark which sought to launch a generic version of Zetia before the April 2017 expiration of the patent exclusivity covering Zetia, it added.
According to the industry experts, the development could give Glenmark an opportunity to earn around $200 million (about Rs700 crore) through the launch the drug in the American market with exclusivity.
Zetia has annual sales of around 1.4 billion in the US alone, a Glenmark spokesperson said.
Glenmark had filed an abbreviated new drug application with the US Food and Drug Administration seeking regulatory approval on 25 October, 2006, and the company had got the tentative approval for the drug last year through its US-based subsidiary Glenmark Generics for Ezetimibe tablets in 10 mg strength.
Last week Glenmark had announced that it has signed an exclusive licensing agreement with the US-based Par Pharmaceutical to sell Ezetimibe in the US market.
“Under the agreement, Glenmark has received a payment from Par for acquiring exclusive rights to market, sell and distribute the product in the US,” Glenmark has said.
The company, however, did not disclose the sum citing confidentiality clause.