Tuesday, April 11, 2017

Lansoprazole - USA

On Apr 10, 2017, The Federal Circuit ruled that Sun Pharma did not infringe Takeda's blockbuster anti-ulcer drug Prevacid (Lansoprazole) with a planned generic version of the dissolving tablets & AFFIRMED the decision of New Jersey federal court.

Sun submitted to FDA ANDA No. 206013 for seeking approval to engage in the commercial manufacture, use and sale of lansoprazole delayed release orally disintegrating tablets, 15 and 30 mg, prior to the expiration of the patent-in-suit.

On Jul 06, 2016, New Jersey court Pursuant to the Stipulation and Order entered final Judgment of Non-infringement Based on Court's Claim Construction entered on June 9, 2016.

Without explaining its reasoning, a three-judge panel upheld the lower court’s decision of non-infringement.

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