Shire wins v Allergan in Lialda patent case

pharmafile | March 30, 2016 | News story | Research and Development, Sales and Marketing Allergan, Shire, lialda 

A US district court has ruled that Shire’s patent for ulcerative colitis drug Lialda is valid through 2020, leaving Allergan unable to sell its generic version of the drug until this time.

Lialda (mesalamine) has been approved in the US since 2007 to treat mild to moderate ulcerative colitis (UC) and also to maintain remission of the condition – a form of inflammatory bowel disease.

The blocked generic version is manufactured by Allergan subsidiary Watson Pharmaceuticals.

As the only drug approved for both these indications, Lialda is a significant earner for Shire, making the Ireland-based company $684.4 million in 2015: representing more than 10% of its overall revenues.

The judge’s ruling also blocks the FDA from approving the generic version until the patent expiration on the original in June 2020.

“Shire is very pleased that the court has once again ruled in our favour, reaffirming the validity of the patent protecting LIALDA,” said James Harrington, senior vice president, global head of Intellectual Property, Shire. “This ruling supports the innovation and value we continue to bring to the patients who benefit from this important medicine that allows them to lead better lives.”

Joel Levy

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