Merck settles Zetia patent suit with Glenmark

After seeking to prevent Mumbai-based Glenmark Pharmaceuticals' US subsidiary from launching a generic version of its Zetia (ezetimibe) through a patent-infringemnt lawsuit, US drug giant Merck & Co has now reached an out of court deal that allows the Indian firm to launch the drug ahead of Merck's patent cover over it expires.

The settlement comes a fortnight after a US judge ruled certain Zetia patent claims being invalid, while upholding the others.

Zetia, a cholesterol modifying agent that inhibits the absorption of cholesterol in the body, had sales of $1.3 billion in the US in 2009.

Glenmark had mounted a legal challenge to the validity of Merck's patent for Zetia, which led Merck to retaliate with a counter suit against Glenmark alleging patent infringement, in a bid to prevent Glenmark from entering the market until until its patent on Zetia expires 25 April 2017.

Now under the agreement, Glenmark can now launch Zetia on 12 December  2016, four months ahead of its patent expiry on April 25 2017 ''under certain circumstances.''

This settlement effectively ends the lawsuit that was scheduled to begin tomorrow, 12 May, involving Glenmark's  challenge  to launch a generic version of Zetia before the April 2017 expiration of the patent exclusivity covering Zetia.

Earlier last week, Glenmark Generics and Par Pharmaceutical entered into an exclusive licensing agreement for marketing the generic version of Merck & Co's `Zetia', on 4 May. (See: Glenmark's US subsidiary gets US FDA approval for Tarka generic)

The world's largest generics manufacturer, Israel's Teva Pharmaceuticals and Mylan Laboratories have challenged another Merck cholesterol drug, Vytorin, a single-pill combination of Zetia with simvastatin, the active ingredient in Merck's Zocor, the combined sales of which last year were $4.3 billion, a 9-per cent decline from 2008, on account of new studies questioning their safety and efficacy.