Santarus begins Zegerid litigation against Par

US-based Santarus, is suing Par Pharmaceutical in the United States District Court for the District of Delaware for an alleged infringement of the patents listed in the FDA's Orange Book for Zegerid (omeprazole/sodium bicarbonate) capsules.

US-based Santarus, is suing Par Pharmaceutical in the United States District Court for the District of Delaware for an alleged infringement of the patents listed in the FDA's Orange Book for Zegerid (omeprazole/sodium bicarbonate) capsules.

The University of Missouri, which is licensor of the patents, has joined Santarus in the litigation as a co-plaintiff.

The lawsuit refers to an Abbreviated New Drug Application (ANDA) filed by Par with the FDA to market a generic version of Zegerid Capsules before the 2016 expiration of three listed US patents (6,645,988, 6,489,346 and 6,699,885).

Santarus filed the lawsuit within the 45 days limit required to prevent the FDA from approving París ANDA for 30 months, or until a district court decision ruling against Santarus.

30th September 2008

PME Digital Edition

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