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23 September 2014Americas

Par pharmaceutical in $100m settlement

Generic drug maker Par Pharmaceutical Companies has settled a long running dispute with Salix Pharmaceuticals over its heartburn drug Zegerid (omeprazole/sodium bicarbonate).

Under the agreement, Par has agreed not to sell or commercialise generic versions of the drug and will also make a one-off payment of $100 million.

The fund will be allocated between Salix and the University of Missouri (UM), the patent’s original owner that licenced it to Salix.

Par has also agreed not to initiate any future challenge to the validity of certain patents that are owned by UM and licensed to Salix.

The settlement was announced in a filing with the US Securities and Exchange Commission (SEC), on Monday (September 22).

The lawsuit was originally filed in 2007 by Santarus, which was bought by Salix last year, and UM, at the US District Court for the District of Delaware.

It accused Par of patent infringement after it filed an Abbreviated New Drug Application seeking approval to market a generic version of the drug.

The court ruled in Par’s favour, leading to the release of a generic in 2010.

However, Santarus and UM appealed against the decision at the US Court of Appeals for the Federal Circuit, which reversed the decision and referred the case back to the district court, leading Par to cease distribution of the generic.

The latest SEC filing said: “Pursuant to the settlement agreement, the parties will enter into a stipulation, dismissing the case with prejudice. The company has agreed to refrain from the reintroduction of its generic Zegerid products until the expiration of plaintiffs’ patents, the unextended terms of which end July 16, 2016.”

According to the  PatentDocs blog, in the year following the first lawsuit Zegerid sales totalled more than $100 million.

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