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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Chubb
US Army
Citi
AstraZeneca
Boehringer Ingelheim
Cipla
McKesson
US Department of Justice

Generated: June 17, 2018

DrugPatentWatch Database Preview

Oxymorphone hydrochloride - Generic Drug Details

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What are the generic sources for oxymorphone hydrochloride and what is the scope of oxymorphone hydrochloride freedom to operate?

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 patent family members in thirty-two countries.

There are nine drug master file entries for oxymorphone hydrochloride. Sixteen suppliers are listed for this compound.
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)
AK322301
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
West-ward Pharms Int OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 090964-002 Sep 27, 2010 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-005 Dec 9, 2011 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-001 Dec 9, 2011 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 201655-005 Dec 9, 2011 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 021610-004 Jun 22, 2006 ➤ Sign Up ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-007 Feb 29, 2008 ➤ Sign Up ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-003 Jun 22, 2006 ➤ Sign Up ➤ Sign Up
Endo Pharms OPANA ER oxymorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021610-004 Jun 22, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for oxymorphone hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,820,982 Oxymorphone controlled release formulations ➤ Sign Up
9,789,103 Method of treating pain utilizing controlled release oxymorphone pharmaceutical compositions and instruction on dosing for renal impairment ➤ Sign Up
8,114,384 Process for the production of an abuse-proofed solid dosage form ➤ Sign Up
8,323,889 Process for the production of an abuse-proofed solid dosage form ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Teva
Mallinckrodt
Farmers Insurance
US Department of Justice
Harvard Business School
McKesson
Colorcon
Federal Trade Commission

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.