Impax Laboratories is challenging patents listed by MSP Singapore that surround the lipid-lowering drug Vytorin, and has filed an abbreviated new drug application to the FDA that contains language seeking to certify a generic version of the drug.
Vytorin, a combination of ezetimibe (Zetia, Merck) and simvastatin (Zocor, Merck), is indicated as an adjunct therapy to diet that reduces total cholesterol, LDL cholesterol, Apo B, and non-HDL cholesterol, to increase HDL-C levels in patients with primary or mixed hyperlipidemia. The drug can work in addition to other lipid lowering treatments and reduce elevated total-C and LDL-C in patients with homozygous familiar hypercholesterolemia.
Earlier this month, MSP Singapore and the Schering-Plough Pharmaceuticals, now a subsidiary of Merck, filed a patent infringement case against Impax with the U.S. District Court for the District of New Jersey.
Zetia and Vytorin are registered trademarks of MSP Singapore, while Schering-Plough, now Merck, manufacturers the drug.
The new drug application is in the FDA’s hands and pending approval. However, the current court action could delay the approval process. If approved, the Hayward, Calif.-based Impax said that its generic sector will begin to market 10 mg/80 mg versions of the generic drug.