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Teva sues Watson over Parkinson's generic

Teva Neuroscience has filed a suit against Watson Laboratories in an effort to block the marketing of a generic version of Parkinson's disease drug Azilect

Teva Neuroscience has filed a suit against Watson Pharmaceuticals' subsidiary Watson Laboratories in an effort to block the company from marketing a generic version of Teva's Parkinson's disease drug Azilect (rasagiline mesylate).

Teva filed the suit in the US District Court for the District of New Jersey after Watson submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA). The ANDA is for approval to market 0.5 and 1.0mg tablet versions of the drug for the treatment of the signs and symptoms of idiopathic Parkinson's disease as initial monotherapy and as adjunct therapy to levodopa.

The generic marketing application includes a "paragraph IV" challenge stating that Watson believes the patent protection on the branded drug to be invalid. As the first generic firm to file an ANDA with a paragraph IV clause, Watson could be entitled to 180 days of generic marketing exclusivity if the drug is approved.

However, Watson's legal move will prevent final approval of the ANDA by the FDA until November 16, 2013 or until the court makes a decision on the matter, whichever comes sooner.

Azilect has annual US sales of about $108m. The drug was the first monoamine oxidase inhibitor to be approved by the FDA for use in Parkinson's disease. 

 

6th October 2010

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