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Oxymorphone hydrochloride - Generic Drug Details
What are the generic drug sources for oxymorphone hydrochloride and what is the scope of 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 fifty-nine patent family members in thirty-two countries.
There are nine drug master file entries for oxymorphone hydrochloride. Twelve suppliers are listed for this compound.
Summary for oxymorphone hydrochloride
| International Patents: | 259 |
| US Patents: | 10 |
| Tradenames: | 4 |
| Applicants: | 12 |
| NDAs: | 18 |
| Drug Master File Entries: | 9 |
| Suppliers / Packagers: | 12 |
| Bulk Api Vendors: | 4 |
| Clinical Trials: | 29 |
| Patent Applications: | 995 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for oxymorphone hydrochloride |
| DailyMed Link: | oxymorphone hydrochloride at DailyMed |
Recent Clinical Trials for oxymorphone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Early Phase 1 |
| M.D. Anderson Cancer Center | Early Phase 1 |
| Mahidol University | Phase 4 |
Recent Litigation for oxymorphone hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Purdue Pharma L.P. v. Ascent Pharmaceuticals, Inc. | 2018-01-11 |
| Purdue Pharma L.P. v. Kashiv Pharma, LLC | 2018-01-03 |
| Purdue Pharma L.P. v. Amneal Pharmaceuticals, LLC | 2018-01-03 |
See all oxymorphone hydrochloride litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Amneal Pharmaceuticals, LLC | 2014-08-22 |
| Amneal Pharmaceuticals, LLC | 2014-01-16 |
| Amneal Pharmaceuticals, LLC | 2013-11-18 |
Pharmacology for oxymorphone hydrochloride
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-002 | Dec 9, 2011 | DISCN | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Endo Pharms | OPANA ER | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201655-002 | Dec 9, 2011 | DISCN | Yes | No | Start Trial | Start Trial | Y | 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 | |||
| Par Pharm | OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200792-004 | Oct 24, 2014 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Par Pharm | OXYMORPHONE HYDROCHLORIDE | oxymorphone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200792-001 | Oct 24, 2014 | 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 | 021610-006 | 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 | 021610-001 | 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 | 021610-007 | Feb 29, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for oxymorphone hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2005063214 | Start Trial |
| Germany | 60223254 | Start Trial |
| Germany | 60219478 | Start Trial |
| Russian Federation | 2006106725 | Start Trial |
| Portugal | 1658055 | Start Trial |
| >Country | >Patent Number | >Estimated 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.
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ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.