Saturday, September 09, 2006

Hatch-Waxman fight over Trileptal (oxcarbazepine)

Taro has filed an ANDA under the Hatch-Waxman Act which includes a challenge to Novartis's Trileptal (oxcarbazepine) for treatment of epilepsy, and Novartis has filed a Hatch-Waxman lawsuit against Taro.

AP reported on September 8:

Taro Pharmaceutical Industries Ltd. [Hawthorne, NY] Friday [Sept. 8] said it filed an abbreviated new drug application with the Food and Drug Administration to sell a generic treatment for seizures.

(...)

Novartis, in turn, has initiated a lawsuit against Taro, the company said, calling it a "standard practice in Paragraph IV patent challenges."

1 Comments:

Blogger nico said...

I have couple of questions -
can they market the drug immediately or they have to wait for the trial? How long should such a trial takes ? Do they have good chances of winning?

12:00 PM  

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