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[†]	Title
US8114383 Endo Pharma	Feb 14, 2012	Aug 06, 2023	Abuse-proofed dosage form
US7851482 Endo Pharma	Dec 14, 2010	Dec 14, 2026	Method for making analgesics
US8309122 Endo Pharma	Nov 13, 2012	Jul 03, 2022	Oxymorphone controlled release formulations
US8329216 Endo Pharma	Dec 11, 2012	Jul 03, 2022	Oxymorphone controlled release formulations
US8192722 Endo Pharma	Jun 05, 2012	Nov 30, 2014	Abuse-proof dosage form
US8309060 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:

Defendant	Case Number	Date Filed	Status
Actavis	1:13-cv-00436 1:12-cv-08985	01/18/2013 12/11/2012	Pending
Sandoz	1:12-cv-08318	11/14/2012	Pending
Impax Laboratories	1:12-cv-08317	11/14/2012	Pending
Teva Pharmaceuticals USA	1:12-cv-08060	11/05/2012	Pending

Table information sourced from Maxval’s Litigation Database.

If you are interested in knowing about the case(s) filed by the plaintiff, please contact us.

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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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