Sunday, January 27, 2013

Impax Laboratories Sued for Filing ANDA for Generic Version of Opana ER

Plaintiff: Endo Pharmaceuticals and Grunenthal GmbH

Defendant: Impax Laboratories

Case Number: 1:13-cv-00435

Date Filed: January 18, 2013

Court: New York Southern District Court

Patents-in-Suit: US8114383, US7851482, US8309122, US8329216, US8192722 and US8309060
Patent Numbers
Current Assignee[*]
Issue Date
Expiration Date[†]
Feb 14, 2012
Aug 06, 2023
Abuse-proofed dosage form
Dec 14, 2010
Dec 14, 2026
Method for making analgesics
Nov 13, 2012
Jul 03, 2022
Oxymorphone controlled release formulations
Dec 11, 2012
Jul 03, 2022
Oxymorphone controlled release formulations
Jun 05, 2012
Nov 30, 2014
Abuse-proof dosage form
Grunenthal (as per face page)
Nov 13, 2012
Nov 30, 2014
Abuse-proofed dosage form
Table information sourced from Maxval’s Assignment Database.

The '383, '722, and '060 patents are owned by Grunenthal GmbH and Endo owns the exclusive license of the patents. 

As in Complaint:
Defendant with the Abbreviated New Drug Application (ANDA) No. 20-4211 seeks approval of  FDA to market oxymorphone hydrochloride extended-release tablets in 5, 7.5, 10, 15, 20, 30 and 40 mg (Impax’s ANDA Products), as a generic version of the drug described in plaintiff’s NDA, which is covered by the patents-in-suit. 

Plaintiff is the current holder[‡] of the New Drug Application (NDA) no. 201655 for Opana ER, (source: Patent Marker) (see Fig. 1) which contains oxymorphone hydrochloride and approved by FDA. Opana® ER is indicated for the relief of moderate to severe pain in patients requiring continuous around-the-clock opioid treatment for an extended period of time.

The Parties:
Endo Pharmaceuticals is a specialty healthcare solutions company focused on branded and generic pharmaceuticals, devices and services. The company operates in four segments: branded pharmaceuticals, generics, devices and services in therapeutic areas, including pain and urology. It has a portfolio of branded pharmaceuticals that includes Lidoderm, Opana ER, Voltaren Gel, Supprelin LA, Valstar, Fortesta Gel, etc.

Grunenthal GmbH[V1]  manufactures and markets pharmaceuticals. It offers pain treatment products for chronic pain and acute pain conditions.

Impax Laboratories  is a specialty pharmaceutical company. The company is engaged in development, manufacture and marketing of bio-equivalent pharmaceutical products, referred to as generics, in addition to the development of branded products.

Other Case(s) Filed:
Endo Pharma has filed nearly 40 cases and the recent cases filed are as listed below:
Case Number
Date Filed
Impax Laboratories
Teva Pharmaceuticals USA
Table information sourced from Maxval’s Litigation Database.
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[*] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
[†] 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.
[‡] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.

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