A patent infringement suit was filed by MSD against Sandoz as a result of the latter filing an abbreviated new drug application (ANDA) with FDA concerning their intent to market a generic version of Zetia, used to treat high cholesterol. The patents involved in suit are:
RE37721 entitledHydroxy-substituted azetidinone compounds useful as hypocholesterolemic agentsissued on May 28, 2002 and expires*by Sep 21, 2013
US5846966 entitledCombinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitorsissued on Dec 08, 1998 and expires*by Sep 21, 2013
US7612058 entitledMethods for inhibiting sterol absorptionissued on Nov 03, 2009 and expires*by Sep 21, 2013
RE42461 entitledHydroxy-substituted azetidinone compounds useful as hypocholesterolemic agentsissued on Jun 14, 2011and expires*by Jun 14, 2028
US7030106 entitledSterol absorption inhibitor compositionsissued on Apr 18, 2006 and expires*by Jan 25, 2022
The patents are currently assigned+to MSD (source: MaxVal’s Assignment Database). MSD alleged that Sandoz’s abbreviated new drug application no. 203-931 to manufacture a generic version of Zetia, filed with FDA had the infringed the above mentioned patents, all of which cover the composition of the drug.
MSD currently holds± the new drug application (NDA) no. 21-445 (source: MaxVal’s Patent Marker), approved by FDA for 10 mg ezetimibe tablets on October 25, 2002, which is sold under the trade name Zetia. It is used to treat high cholesterol, along with a low-fat, low-cholesterol diet. It is sometimes given with other cholesterol-lowering medications. It is also used to treat high blood sitosterol and campesterol along with diet therapy. Plaintiffs wanted judgment that defendant has infringed the patents and an injunction barring their products until expiration of the patents, along with costs and expenses.
The Court rendered its final verdict pursuant to the parties agreeing upon a consent judgment. The Judge ordered:
Claims, counterclaims are dismissed without prejudice
Defendant is enjoined from manufacturing/marketing a generic version of Zetia until April 25, 2017