MSD, Sandoz Settle Suit over Zetia Generic

Case Filed: Sep 27, 2012

Case Closed: Sep 09, 2013

Court: New Jersey District Court

Judge: Jose L. Linares

Case Summary:

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 entitled Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents issued on May 28, 2002 and expires* by Sep 21, 2013
•         US5846966 entitled Combinations of hydroxy-substituted azetidinone compounds and HMG CoA Reductase Inhibitors issued on Dec 08, 1998 and expires* by Sep 21, 2013
•         US7612058 entitled Methods for inhibiting sterol absorption issued on Nov 03, 2009 and expires* by Sep 21, 2013
•         RE42461 entitled Hydroxy-substituted azetidinone compounds useful as hypocholesterolemic agents issued on Jun 14, 2011and expires* by Jun 14, 2028
•         US7030106 entitled Sterol absorption inhibitor compositions issued 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
•        Parties to bear their own costs and expense

See 2:12-cv-06077 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts. 

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* Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents. 

+ MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.

± Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.