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Oxycodone hydrochloride - Generic Drug Details
What are the generic drug sources for oxycodone hydrochloride and what is the scope of freedom to operate?
Oxycodone hydrochloride
is the generic ingredient in five branded drugs marketed by Ani Pharms Inc, Avanthi Inc, Genus Lifesciences, Lannett Co Inc, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Hi Tech, Pharm Assoc, Specgx Llc, Vistapharm, Wes Pharma Inc, West-ward Pharms Int, Wockhardt Bio Ag, Purdue Pharma Lp, Roxane, Zyla, Actavis Elizabeth, Alvogen, Amneal Pharms, Aurolife Pharma Llc, Epic Pharma Llc, Nesher Pharms, Nuvo Pharm, Rhodes Pharms, Sun Pharm Inds Inc, Vintage Pharms, and Daiichi Sankyo Inc, and is included in forty-nine NDAs. There are twenty-nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Oxycodone hydrochloride has five hundred and ninety-one patent family members in forty-eight countries.
There are nineteen drug master file entries for oxycodone hydrochloride. Forty-eight suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for oxycodone hydrochloride
| International Patents: | 591 |
| US Patents: | 29 |
| Tradenames: | 5 |
| Applicants: | 30 |
| NDAs: | 49 |
| Drug Master File Entries: | 19 |
| Suppliers / Packagers: | 48 |
| Bulk Api Vendors: | 20 |
| Clinical Trials: | 441 |
| Patent Applications: | 2,792 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for oxycodone hydrochloride |
| DailyMed Link: | oxycodone hydrochloride at DailyMed |
Recent Clinical Trials for oxycodone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Northwestern University | Phase 4 |
| Yale University | N/A |
| Dean Elterman | Phase 4 |
Recent Litigation for oxycodone hydrochloride
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| INSPIRION DELIVERY SCIENCES, LLC v. TEVA PHARMACEUTICALS USA, INC. | 2019-04-19 |
| Purdue Pharma L.P. v. Ascent Pharmaceuticals, Inc. | 2018-06-07 |
| Purdue Pharma L.P. v. Ascent Pharmaceuticals, Inc. | 2018-01-11 |
See all oxycodone hydrochloride litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Kashiv Pharma, LLC | 2018-02-28 |
| Kashiv Pharma, LLC | 2018-02-27 |
| Amneal Pharmaceuticals, LLC | 2016-05-11 |
Generic filers with tentative approvals for OXYCODONE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 80MG | TABLET, EXTENDED RELEASE; ORAL |
| Start Trial | Start Trial | 80MG | TABLET, EXTENDED RELEASE; ORAL |
| Start Trial | Start Trial | 40MG | TABLET, EXTENDED RELEASE; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for oxycodone hydrochloride
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Synonyms for oxycodone hydrochloride
| (-)-14-Hydroxydihydrocodeinone |
| (-)-Oxycodone |
| (1S,5R,13R,17S)-17-hydroxy-10-methoxy-4-methyl-12-oxa-4-azapentacyclo[9.6.1.0;{1,13}.0;{5,17}.0;{7,18}]octadeca-7(18),8,10-trien-14-one |
| (4R,4aS,7aR,12bS)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one |
| (4R,4aS,7aR,12bS)-4a-hydroxy-9-methoxy-3-methyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinoline-7-one;hydrochloride |
| (5?)-4,5-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride |
| (5alpha,17S)-14-hydroxy-3-methoxy-17-methyl-6-oxo-4,5-epoxymorphinan-17-ium chloride |
| (5alpha)-14-hydroxy-17-methyl-3-(methyloxy)-4,5-epoxymorphinan-6-one |
| 124-90-3 |
| 124-90-3 (hydrochloride) |
| 14-hydroxy-3-methoxy-17-methyl-4,5alpha-epoxymorphinan-6-one |
| 14-hydroxy-3-methoxy-17-methyl-4,5alpha-epoxymorphinan-6-one hydrochloride |
| 14-Hydroxydihydrocodeinone |
| 14-Hydroxydihydrocodeinone hydrochloride |
| 4,5-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one |
| 4,5.alpha.-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one |
| 4,5alpha-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one |
| 4,5alpha-Epoxy-14-hydroxy-3-methoxy-17-methylmorphinan-6-one hydrochloride |
| 4aH-8,5-bcd]furan-5(6H)-one, 7,7a,8,9-tetrahydro-7a-hydroxy-3-methoxy-12-methyl- |
| 6-deoxy-7,8-dihydro-14-hydroxy-3-O-methyl-6-oxomorphine |
| 76-42-6 |
| AC-16043 |
| AC1Q4DTG |
| AKOS015962233 |
| AKOS024457896 |
| AN-22961 |
| API0009028 |
| Apo-oxycodone CR |
| Avridi |
| BDBM50370595 |
| BRN 0043446 |
| BRUQQQPBMZOVGD-XFKAJCMBSA-N |
| C08018 |
| C08026 |
| CD35PMG570 |
| CHEBI:7852 |
| CHEBI:7859 |
| CHEMBL1200890 |
| CHEMBL656 |
| Codeinone, 7,8-dihydro-14-hydroxy- |
| Codeinone, dihydro-14-hydroxy- |
| Codeinone, dihydrohydroxy- |
| Codeinone,8-dihydro-14-hydroxy- |
| D00847 |
| D05312 |
| DB00497 |
| DEA No. 9143 |
| Dihydro-14-hydroxycodeinone |
| Dihydrohydroxycodeinone |
| Dihydrohydroxycondeinone |
| Dihydrone |
| Dihydrone hydrochloride |
| Dihydrooxycodeinone hydrochloride |
| Dihydroxycodeinone |
| Dihydroxycodeinone hydrochloride |
| Diphydrone |
| DTXSID5023407 |
| EINECS 200-960-2 |
| Endine (Australia) |
| Endone |
| Eubine |
| Eubine [France] |
| Eucodal |
| Eucodalum |
| Eukodal |
| Eutagen |
| FT-0673447 |
| GTPL7093 |
| HSDB 3142 |
| Hydroxycodeinon |
| LS-92148 |
| Morphinan-6-one, 4,5-alpha-epoxy-14-hydroxy-3-methoxy-17-methyl- |
| Morphinan-6-one, 4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, (5alpha)- |
| Morphinan-6-one, 4,5alpha-epoxy-14-hydroxy-3-methoxy-17-methyl- |
| Morphinan-6-one, 4,5alpha-epoxy-14-hydroxy-3-methoxy-17-methyl- (8CI) |
| Morphinan-6-one,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, (5.alpha.)- |
| Morphinan-6-one,5.alpha.-epoxy-14-hydroxy-3-methoxy-17-methyl- |
| MUZQPDBAOYKNLO-RKXJKUSZSA-N |
| NSC 19043 |
| NSC-19043 |
| NSC19043 |
| Ossicodone |
| Ossicodone [DCIT] |
| Oxanest |
| Oxecta (TN) |
| Oxicodona |
| Oxicodona [INN-Spanish] |
| Oxicon |
| Oxicone |
| Oxiconum |
| Oxikon |
| Oxycodeinon |
| Oxycodeinone |
| Oxycodon |
| oxycodone |
| Oxycodone (USAN/INN) |
| Oxycodone [USAN:INN:BAN] |
| Oxycodone 0.1 mg/ml in Methanol |
| Oxycodone 1.0 mg/ml in Methanol |
| Oxycodone Concentrate |
| Oxycodone Hcl |
| Oxycodone hydrochloride (USP) |
| Oxycodone hydrochloride solution |
| Oxycodone hydrochloride solution, 1.0 mg/mL in methanol, analytical standard, for drug analysis |
| Oxycodone hydrochloride, analytical standard |
| Oxycodone hydrochloride, European Pharmacopoeia (EP) Reference Standard |
| Oxycodone hydrochloride, United States Pharmacopeia (USP) Reference Standard |
| oxycodone monohydrochloride |
| Oxycodone solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material |
| Oxycodonum |
| Oxycodonum [INN-Latin] |
| Oxycon |
| Oxycone |
| Oxycontin |
| Oxycontin (TN) |
| Oxyfast |
| OxyIR |
| Oxyneo |
| Pancodine |
| Pancodone Retard |
| Pancodone retard (United Kingdom) |
| Percobarb |
| Percodan |
| Percolone |
| PF-00345439 |
| PF06 |
| PTI-821 |
| Roxicodone |
| Roxicodone (TN) |
| SCHEMBL2737 |
| SCHEMBL30095 |
| Supendol |
| Supendol [Canada] |
| Supeudol |
| Tecodin |
| Tekodin |
| Tekodin (free base) |
| Thecodine |
| Thekodin |
| Theocodin |
| UNII-CD35PMG570 |
| WLN: T B6566 B6/CO 4ABBC R BX FV HO PN GHT&&TTJ CQ JO1 P1 |
| Xtampza |
| Xtampza ER |
| ZINC403533 |
US Patents and Regulatory Information for oxycodone hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wockhardt Bio Ag | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 206456-001 | Jun 16, 2015 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-005 | Apr 5, 2010 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Rhodes Pharms | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | TABLET;ORAL | 091490-005 | Mar 9, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Wes Pharma Inc | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 209897-001 | Sep 6, 2017 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-003 | Apr 5, 2010 | RX | 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 oxycodone hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-005 | Apr 5, 2010 | Start Trial | Start Trial |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-001 | Apr 5, 2010 | Start Trial | Start Trial |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-003 | Apr 5, 2010 | Start Trial | Start Trial |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-004 | Apr 5, 2010 | Start Trial | Start Trial |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-003 | Apr 5, 2010 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for oxycodone hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 101568100 | Start Trial |
| Japan | 5980881 | Start Trial |
| European Patent Office | 2384754 | Start Trial |
| Chile | 2004002017 | Start Trial |
| Israel | 178787 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for oxycodone hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1685839 | 92292 | Luxembourg | Start Trial | PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.