Cozaar

Merck to be hit by Cozaar generics

pharmafile | April 9, 2010 | News story | |  Merck, Teva, generics 

Generic versions of Merck’s hypertension treatments Cozaar and Hyzaar are to be launched in the US for the first time.

The FDA has given final approval for Israel-based Teva to launch its rival to the one of the biggest-selling blood pressure drugs.

Sales of Cozaar and combination product Hyzaar have slipped over the last year, but still net around $1.6 billion in US sales alone.

The FDA has also approved applications from Mylan, Roxane Laboratories and Torrent Pharmaceuticals to produce a version of Hyzaar in 100 mg/12.5 mg strength only.

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Merck has been bracing itself for this assault, last year admitting it was expecting a “significant decline in future sales” of its ageing brands.

As well as losing marketing exclusivity in the US they have also gone off patent in major European markets this year.

Teva has been given the standard 180-day period of exclusivity to market its versions.

Cozaar was originally licensed to treat hypertension and extended that to two other indications: stroke protection for hypertensive patients with concomitant left ventricular hypertrophy, and also renal protection for type II diabetes patients with nephropathy.

The new products are manufactured by Teva at its facility in North Wales, Pennsylvania. Teva says that more that 80% of its sales come from North America and Western Europe.

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