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Oxymorphone hydrochloride - Generic Drug Details

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What are the generic sources for oxymorphone hydrochloride and what is the scope of patent protection?

Oxymorphone hydrochloride is the generic ingredient in four branded drugs marketed by Endo Pharms, Actavis Elizabeth, Hikma, Impax Labs, Par Pharm, Specgx Llc, Sun Pharm Inds Ltd, Ascent Pharms Inc, Aurolife Pharma Llc, Avanthi Inc, Epic Pharma Llc, and Teva, and is included in eighteen NDAs. There are ten patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Oxymorphone hydrochloride has two hundred and fifty-three patent family members in thirty-two countries.

There are nine drug master file entries for oxymorphone hydrochloride. Eight suppliers are listed for this compound.

Summary for oxymorphone hydrochloride

International Patents:	253
US Patents:	10
Tradenames:	4
Applicants:	12
NDAs:	18
Drug Master File Entries:	9
Suppliers / Packagers:	8
Bulk Api Vendors:	4
Clinical Trials:	29
Patent Applications:	1,008
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for oxymorphone hydrochloride
DailyMed Link:	oxymorphone hydrochloride at DailyMed

Recent Clinical Trials for oxymorphone hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	Early Phase 1
M.D. Anderson Cancer Center	Early Phase 1
Mahidol University	Phase 4

See all oxymorphone hydrochloride clinical trials

Pharmacology for oxymorphone hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for oxymorphone hydrochloride

Adjuvants, Anesthesia

Analgesics, Opioid

Narcotics

US Patents and Regulatory Information for oxymorphone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-001	Dec 9, 2011		DISCN	Yes	No
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-006	Dec 9, 2011		DISCN	Yes	No			Y
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-005	Dec 9, 2011		DISCN	Yes	No			Y
Teva	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET;ORAL	091443-001	Feb 15, 2011	AB	RX	No	No
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-003	Dec 9, 2011		DISCN	Yes	No				Y
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-007	Feb 29, 2008		DISCN	No	No			Y
Actavis Elizabeth	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079046-003	Jul 11, 2013		DISCN	No	No

Expired US Patents for oxymorphone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-005	Feb 29, 2008
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-004	Jun 22, 2006
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-003	Jun 22, 2006
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-001	Jun 22, 2006
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-003	Jun 22, 2006
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-004	Jun 22, 2006
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-002	Jun 22, 2006

International Patents for oxymorphone hydrochloride

Country	Patent Number	Estimated Expiration
Australia	2002320309
Slovenia	1740156
Israel	173478
World Intellectual Property Organization (WIPO)	03004032
Poland	1842533
Germany	102005005446
Slovenia	1765298