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Last Updated: November 22, 2019

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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, Actavis Elizabeth, Impax Labs, Par Pharm, Specgx Llc, Sun Pharm Inds Ltd, West-ward Pharms Int, 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 forty-five patent family members in thirty-two countries.

There are nine drug master file entries for oxymorphone hydrochloride.

Recent Clinical Trials for OXYMORPHONE HYDROCHLORIDE

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SponsorPhase
M.D. Anderson Cancer CenterEarly Phase 1
National Cancer Institute (NCI)Early Phase 1
Mahidol UniversityPhase 4

See all OXYMORPHONE HYDROCHLORIDE clinical trials

Recent Litigation for OXYMORPHONE HYDROCHLORIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharma L.P. v. Ascent Pharmaceuticals, Inc.2018-01-11
Purdue Pharma L.P. v. Amneal Pharmaceuticals, LLC2018-01-03
Purdue Pharma L.P. v. Kashiv Pharma, LLC2018-01-03

See all OXYMORPHONE HYDROCHLORIDE litigation

PTAB Litigation
PetitionerDate
Amneal Pharmaceuticals, LLC2014-08-22
Amneal Pharmaceuticals, LLC2014-01-16
Amneal Pharmaceuticals, LLC2013-11-18

See all OXYMORPHONE HYDROCHLORIDE litigation

Pharmacology for OXYMORPHONE HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for OXYMORPHONE HYDROCHLORIDE
Synonyms for OXYMORPHONE HYDROCHLORIDE
(5alpha)-4,5-Epoxy-3,14-dihydroxy-17-methylmorphinan-6-one hydrochloride
357-07-3
4,5-alpha-Epoxy-3,14-dihydroxy-17-methylmorphinan-6-one hydrochloride
4,5alpha-Epoxy-3,14-dihydroxy-17-methylmorphinan-6-one hydrochloride
5Y2EI94NBC
76-41-5 (Parent)
AKOS027326705
BCGJBQBWUGVESK-KCTCKCTRSA-N
C17H19NO4.HCl
CHEBI:7866
CHEMBL1200794
D00844
DTXSID10189214
EINECS 206-610-5
LS-92124
Morphinan-6-one, 3,14-dihydroxy-4,5-alpha-epoxy-17-methyl-, hydrochloride
Morphinan-6-one, 4,5-epoxy-3,14-dihydroxy-17-methyl-, hydrochloride, (5alpha)-
Numorphan (TN)
Opana (TN)
Opana ER
Oxymorphinone hydrochloride
Oxymorphone HCl
Oxymorphone hydrochloride (USP)
Oxymorphone hydrochloride [USAN]
Oxymorphone hydrochloride [USP]
SCHEMBL41770
UNII-5Y2EI94NBC

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
Teva OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 091443-002 Feb 15, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-001 Dec 9, 2011 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Actavis Elizabeth OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 079046-004 Jul 11, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-004 Dec 9, 2011 DISCN Yes No   Start Trial   Start Trial   Start Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-007 Feb 29, 2008   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-003 Jun 22, 2006   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-006 Feb 29, 2008   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-001 Jun 22, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.