Glenmark Pharmaceuticals Settles Patent Litigation with Merck & Co Over Cholesterol Lowering Generic Drug

India's Glenmark Pharmaceuticals has settled a patent litigation with US-based Merck & Co over its cholesterol lowering generic drug 'Ezetimibe', a generic version of Merck's patented drug 'Zetia'. The settlement allows Glenmark to launch its product in the US market, potentially earning around $200 million in revenue. The lawsuit was fought in the US court, where Glenmark had filed an Abbreviated New Drug Application with first-to-file status, entitling it to 180 days of marketing exclusivity in the US.

Key Takeaways:

• Glenmark Pharmaceuticals has settled a patent litigation with Merck & Co over its cholesterol lowering generic drug 'Ezetimibe', allowing the company to launch its product in the US market.
• The settlement will give Glenmark an opportunity to earn around $200 million through the launch of the drug in the American market with exclusivity.
• Ezetimibe is a generic version of Merck's patented drug 'Zetia', which has annual sales of around $1.4 billion in the US alone.
• Glenmark had filed an abbreviated new drug application with the US Food and Drug Administration seeking regulatory approval on October 25, 2006, and received tentative approval last year through its US-based subsidiary Glenmark Generics.
• The company has also signed an exclusive licensing agreement with Par Pharmaceutical to sell Ezetimibe in the US market, although the payment details were not disclosed due to a confidentiality clause.

Statistics:

• Estimated revenue earnings for Glenmark Pharmaceuticals: $200 million
• Annual sales of Merck's patented drug 'Zetia' in the US: $1.4 billion
• Date of filing of Abbreviated New Drug Application with the US Food and Drug Administration: October 25, 2006
• Weighted time frame for exclusivity of marketing: 180 days
• Expiration date of Merck's patent exclusivity for Zetia: April 25, 2017

Sources:

• PTI (Press Trust of India) [No publication date specified]