Sunday, September 29, 2013

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]
Mar 09, 2010
Mar 30, 2025
Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Mar 09, 2010
Mar 30, 2025
Oxycodone hydrochloride having less than 25 PPM 14-hydroxycodeinone
Mar 23, 2010
Mar 30, 2025
Oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone
Dec 03, 2002
Mar 02, 2019
Hot-melt extrudable pharmaceutical formulation
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.

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