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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 eleven 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. Ten suppliers are listed for this compound.

Summary for oxymorphone hydrochloride

International Patents:	253
US Patents:	11
Tradenames:	4
Applicants:	12
NDAs:	18
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	32
Patent Applications:	1,100
Formulation / Manufacturing:	see details
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
Kaohsiung Medical University Chung-Ho Memorial Hospital	Phase 4
West Virginia University	Phase 4
West Virginia Clinical and Translational Science Institute	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

Anatomical Therapeutic Chemical (ATC) Classes for oxymorphone hydrochloride

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

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	021610-004	Jun 22, 2006		DISCN	Yes	No			Y
Specgx Llc	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	202946-003	Jun 27, 2014		DISCN	No	No
Endo Pharms	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201655-002	Dec 9, 2011		DISCN	Yes	No				Y
Impax Labs	OXYMORPHONE HYDROCHLORIDE	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	079087-005	Jun 14, 2010		RX	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	021610-003	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	021610-004	Jun 22, 2006

International Patents for oxymorphone hydrochloride

Country	Patent Number	Estimated Expiration
Croatia	P20160390
World Intellectual Property Organization (WIPO)	2005102286
Norway	339522
Germany	102004020220