Purdue, Par Conclude Lawsuit over Generic OxyContin

Case Filed: Mar 23, 2011

Case Closed: Sep 24, 2013

Court: New York Southern District Court

Judge: Sidney H. Stein

Case Summary:

A patent infringement suit was filed by Purdue, Grunenthal and Texas System against Par as a result of the latter’s filing of an abbreviated new drug application (ANDA) with FDA concerning their intent to market a generic version of OxyContin, used to treat moderate to severe pain. The patents involved in the suit are:

Patent Number Current Assignee[i]	Issued Date	Expiration Date[ii]	Title
US7674799 Purdue	Mar 09, 2010	Mar 30, 2025	Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
US7674800 Purdue	Mar 09, 2010	Mar 30, 2025	Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
US7683072 Purdue	Mar 23, 2010	Mar 30, 2025	Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
US6488963 Texas System	Dec 03, 2002	Mar 02, 2019	Hot-melt extrudable pharmaceutical formulation
US7776314 Grunenthal GmbH	Aug 17, 2010	Jun 17, 2022	Abuse-proofed dosage system

Current Assignee sourced from MaxVal’s Assignment Database.

Purdue alleged that Par’s abbreviated new drug application no. 202434 with FDA seeking approval to engage in commercial manufacturing of the drug containing oxycodone hydrochloride extended release tablets has infringed the above said patents, all of which cover the composition of the drug.

Purdue currently holds new drug application (NDA) no. 022272 for controlled-release oxycodone pain-relief medication OxyContin approved by FDA on April 5, 2010. It is indicated for the management of moderate to severe pain when a continuous, round-the-clock opioid analgesic is needed for an extended period of time. 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 parties reached a settlement on Sep 20, 2013. Pursuant to the terms of settlement, it was agreed that:

•        5 of the patents-in-suit are valid and enforceable and Par’s ANDA would infringe the patents
•         Par’s product will be enjoined from infringing until the expiration date

The Court signed off a consent judgment ordering dismissal without prejudice with no charges imposed on any parties.  

See 1:11-cv-02038 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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

[ii] 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.