Tuesday, January 8, 2013

Shionogi sues Sandoz to block early entry of Doribax (doripenem hydrate) generics in the US

Shionogi & Co., Ltd. has filed a patent infringement action in the U.S. District Court in New Jersey on December 28, 2012, against Sandoz regarding Sandoz’s submission of an Abbreviated New Drug Application with the Food and Drug Administration seeking approval for a generic version of Doribax® (generic name: doripenem hydrate, product name in Japan: Finibax®) before the expiration of Shionogi’s intellectual property for the crystal form of Doribax® on March 30, 2021. Shionogi has licensed the commercial rights to Doribax® to Peninsula Pharmaceuticals, Inc., currently a subsidiary of Johnson & Johnson (Head Office: New Jersey, USA; Chairman & CEO: William C. Weldon) in the United States.
Doripenem hydrate is an antibiotic discovered by Shionogi which has already been approved in 87
countries as Finibax®/Doribax®

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