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Generic Parkinson’s drug hits US market Posted 21/08/2015

Indian generics giant Dr Reddy’s Laboratories announced on 12 August 2015 that it had launched generic pramipexole dihydrochloride extended-release tablets in dosages of 0.375, 0.75, 1.5, 3 and 4.5 mg, following approval of the company’s abbreviated new drug application by the US Food and Drug Administration on 7 August 2015.

The drug is a generic version of Boehringer Ingelheim’s Parkinson’s treatment Mirapex ER (pramipexole). US sales of brand-name and generic pramipexole were approximately US$48.3 million for the last 12 months ending June 2015, according to IMS Health.

Boehringer Ingelheim only received approval for its Parkinson’s drug in 2010 and had expected patents to protect it until 2028 and 2029. However, there are now numerous generics makers with pramipexole generics on the market in the US.

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Source: Dr Reddy’s, US FDA

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