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Last Updated: July 16, 2020

DrugPatentWatch Database Preview

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, 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. Nine 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
Aurolife Pharma Llc OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 204459-001 Apr 26, 2016 AB RX No No   Start Trial   Start Trial   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
Endo Pharms OPANA oxymorphone hydrochloride INJECTABLE;INJECTION 011707-001 Approved Prior to Jan 1, 1982 DISCN 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
Hikma OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 090964-001 Sep 27, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 079046-001 Dec 13, 2010 DISCN 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
>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 021610-006 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 021610-005 Feb 29, 2008   Start Trial   Start Trial
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 021610-007 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 021610-001 Jun 22, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Colorcon
Dow
McKinsey
Johnson and Johnson

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 verification 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.