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Teva's US approval for hypertension drugs

Teva Pharmaceutical has won US approval for its generic versions of Merck's blockbuster blood-pressure drugs Cozaar and Hyzaar

Teva Pharmaceutical has won US approval for its generic versions of Merck's blockbuster blood-pressure (hypertension) drugs Cozaar (losartan) and Hyzaar (hydrochlorothiazide and losartan), and intends to launch sales immediately.

Teva, the world's biggest generic drug producer, will have 180 days to market the generics exclusively, an award generally given to companies that challenge patents first.

An exclusivity period can allow generic companies a window of significant sales before rivals rush in and pricing freefalls.

Teva said a federal appeals court this week rejected an effort by generic drug producers Apotex and Roxane Laboratories to challenge Teva's right to that exclusivity period.

Last week, Apotex and Roxane sued the US Food and Drug Administration, arguing that a key patent for the drugs had expired and therefore no company was eligible for the exclusive rights.

Cozaar and Hyzaar, which have annual US sales of about $1.6bn, have been among Merck's biggest selling products, but the pharma company has been bracing for generic competition this year.

8th April 2010

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