Impax Laboratories, Inc. announced that it has reached agreement with Daiichi Sankyo, Inc. and Genzyme Corporation to settle pending patent litigation relating to its generic versions of Welchol (colesevelam HCl) tablets, 625 mg and oral suspensions, 1.875 gm/packet and 3.75 gm/packet products. Under the terms of the settlement, Impax will be permitted to launch its tablet product on March 2, 2015 or earlier under certain circumstances. The settlement further provides for the launch of the oral suspension products, under terms that were not disclosed. As a result of this settlement, the litigation will be dismissed.

The company believes that it is the first to file an ANDA with a paragraph IV certification with respect to the colesevelam HCl 625mg tablet product, and expects to be entitled to at least three months of market exclusivity prior to the launch of additional ANDA products. Upon the agreed-upon launch dates, Global Pharmaceuticals, Impax's generic division, will commercialize the products.

Welchol is indicated as an adjunct to diet and exercise to reduce elevated Low-Density Lipoprotein Cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A (HMG CoA) reductase inhibitor and for the treatment of type 2 diabetes mellitus. According to Wolters Kluwer Health, US sales of Welchol tablets and Welchol Oral Suspension were approximately $ 325 million and $ 65 million, respectively, for the twelve-month period ending May 2011.

Impax Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.