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Last Updated: August 10, 2020

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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.

Recent Clinical Trials for oxymorphone hydrochloride

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

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

See all oxymorphone hydrochloride clinical trials

Pharmacology for oxymorphone hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for oxymorphone hydrochloride

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   Start Trial   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-006 Dec 9, 2011 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-005 Dec 9, 2011 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Teva OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 091443-001 Feb 15, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-003 Dec 9, 2011 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-007 Feb 29, 2008 DISCN No No   Start Trial   Start Trial Y   Start Trial
Actavis Elizabeth OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 079046-003 Jul 11, 2013 DISCN No 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 021610-005 Feb 29, 2008   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-004 Jun 22, 2006   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 021610-001 Jun 22, 2006   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 021610-004 Jun 22, 2006   Start Trial   Start Trial
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-002 Jun 22, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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