Mylan in patent settlement deals with Pfizer over Caduet and Lipitor

26 January 2011

US generics drug major Mylan (Nasdaq: MYL) says that it has entered into two patent settlement agreement with global pharma behemoth Pfizer  (NYSE: PFE). The first resolves litigation related to cardiovascular agent Caduet (amlodipine besilate and atorvastatin) 2.5 mg/10, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg and 10 mg/80 mg.

Pfizer sued Mylan early last year for patent infringement of Caduet, after the generics firm filed an Abbreviated New Drug Application with the Food and Drug Administration. Pfizer has attempted to protect revenues from amlodipine, the active ingredient of its antihypertensive Norvasc, by launching Caduet which also contains the cholesterol lowerer atorvastatin in advance of the Norvasc patent loss.

Pursuant to the settlement agreement, otherwise known as a pay-for-delay arrangement, pending litigation will be dismissed and Mylan may begin to market and sell a generic version of Caduet on November 30, 2011, or earlier under certain circumstances.

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