Impax settles patent litigation relating to Welchol products

HAYWARD, Calif. — Impax Labs has agreed not to market a generic version of a drug designed to reduce blood sugar and cholesterol in tablet form until 2015.

Impax said the agreement was part of a pending patent litigation between Impax and Daiichi Sankyo and Genzyme, the makers of Welchol (colesevelam HCl) tablets in the 625-mg strength, as well as oral suspensions in 1.875 g/packet and 3.75 g/packet sizes. Under the terms of the agreement, Impax will launch its tablet product on March 2, 2015 or earlier under certain circumstances. Terms pertaining to the launch of generic Welchol oral suspension products by Impax were not disclosed.

U.S. sales of Welchol tablets and Welchol oral suspension were approximately $325 million and $65 million, respectively, for the 12-month period ended in May, according to Wolters Kluwer Health data.