Following receipt of the notice from the FDA that Impax’s ANDA had been accepted for filing, Impax has notified the New Drug Application holder and patent owners of its paragraph IV certification. The challenge involves Welchol (Colesevelam HCl) tablets, 625mg.
Reportedly, on January 14, 2010, Daiichi Sankyo and Genzyme have filed suit for patent infringement against Impax in the US District Court for the District of Delaware. The action formally initiates the patent challenge process under the Hatch-Waxman Act.
The company said that once the ANDA is approved by FDA, Global Pharmaceuticals, Impax’s generic division, will commercialise the products.
Welchol is indicated as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzyme A reductase inhibitor (statin). The drug also reduce LDL-C levels in boys and postmenarchal girls (10 to 17 years of age) with heterozygous familial hypercholesterolemia as monotherapy or in combination with a statin. The treatment is used for patients who have failed an adequate trial of diet therapy, and improve glycemic control in adults with type 2 diabetes mellitus.