Oxymorphone hydrochloride - Generic Drug Details

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What are the generic drug 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, Endo Operations, 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 five 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 four patent family members in thirty-two countries.

There are seven drug master file entries for oxymorphone hydrochloride. Nine suppliers are listed for this compound.

Summary for oxymorphone hydrochloride

International Patents:	204
US Patents:	5
Tradenames:	4
Applicants:	13
NDAs:	18
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	37
Patent Applications:	1,176
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for oxymorphone hydrochloride
What excipients (inactive ingredients) are in oxymorphone hydrochloride?	oxymorphone hydrochloride excipients list
DailyMed Link:	oxymorphone hydrochloride at DailyMed

Recent Clinical Trials for oxymorphone hydrochloride

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

Sponsor	Phase
Assiut University	Phase 4
Kaohsiung Medical University Chung-Ho Memorial Hospital	Phase 4
National Institutes of Health (NIH)	Phase 2

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

Anatomical Therapeutic Chemical (ATC) Classes for oxymorphone hydrochloride

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for OXYMORPHONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OPANA ER	Extended-release Tablets	oxymorphone hydrochloride	20 mg, 30 mg and 40 mg	201655	1	2012-04-03
OPANA ER	Extended-release Tablets	oxymorphone hydrochloride	5 mg	201655	1	2012-03-26
OPANA ER	Extended-release Tablets	oxymorphone hydrochloride	7.5 mg, 10 mg, and 15 mg	201655	1	2012-03-23

US Patents and Regulatory Information for oxymorphone hydrochloride

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200822-004	Jul 15, 2013		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Actavis Elizabeth	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079046-007	Jul 11, 2013		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-003	Jun 22, 2006		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe		Y		⤷ Subscribe
Actavis Elizabeth	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079046-002	Dec 13, 2010		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-007	Feb 29, 2008		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe		Y		⤷ Subscribe
Impax Labs	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079087-004	Dec 21, 2010		RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-002	Dec 9, 2011		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for oxymorphone hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-005	Feb 29, 2008	⤷ Subscribe	⤷ Subscribe
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-004	Dec 9, 2011	⤷ Subscribe	⤷ Subscribe
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-007	Feb 29, 2008	⤷ Subscribe	⤷ Subscribe
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-004	Jun 22, 2006	⤷ Subscribe	⤷ Subscribe
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-006	Dec 9, 2011	⤷ Subscribe	⤷ Subscribe
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-004	Dec 9, 2011	⤷ Subscribe	⤷ Subscribe
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-007	Dec 9, 2011	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for oxymorphone hydrochloride

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Country	Patent Number	Title	Estimated Expiration
Chile	2004002017	FORMA DE DOSIFICACION TERMOFORMADA A PRUEBA DE ABUSO QUE CONTIENE (A) UNO O MAS PRINCIPIOS ACTIVOS SUSCEPTIBLES DE ABUSO, (B) OPCIONALMENTE SUSTANCIAS AUXILIARES, (C) AL MENOS UN POLIMERO SINTETICO O NATURAL DE UN GRUPO DEFINIDO Y (D) OPCIONALMENTE A	⤷ Subscribe
South Korea	101160813		⤷ Subscribe
Spain	2407143		⤷ Subscribe
Mexico	2009006283	METODO MEJORADO PARA PRODUCIR ANALGESICOS. (IMPROVED METHOD FOR MAKING ANALGESICS.)	⤷ Subscribe
Canada	2595954	FORMES GALENIQUES RESISTANTES A LA RUPTURE A LIBERATION RETARDEE (BREAK-RESISTANT DELAYED-RELEASE FORMS OF ADMINISTRATION)	⤷ Subscribe
Poland	2478896		⤷ Subscribe
Taiwan	I381860		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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