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Oxycodone hydrochloride - Generic Drug Details
What are the generic sources for oxycodone hydrochloride and what is the scope of oxycodone hydrochloride 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, Ascent Pharms Inc, Hi-tech Pharmacal, Pharm Assoc, Specgx Llc, Vistapharm, Wes Pharma Inc, West-ward Pharms Int, Wockhardt Bio Ag, Purdue Pharma Lp, Roxane, Egalet Us Inc, Actavis Elizabeth, Alvogen Malta, Amneal Pharms, Aurolife Pharma Llc, Epic Pharma Llc, Ken Lifescience, Nesher Pharms, Rhodes Pharms, Sun Pharm Inds Inc, Vintage Pharms, and Daiichi Sankyo Inc, and is included in forty-six NDAs. There are twenty-six patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.There are nineteen drug master file entries for oxycodone hydrochloride. Fifty-six suppliers are listed for this compound. There are four tentative approvals for this compound.
Summary for oxycodone hydrochloride
| US Patents: | 26 |
| Tradenames: | 5 |
| Applicants: | 29 |
| NDAs: | 46 |
| Drug Master File Entries: | 19 |
| Suppliers / Packagers: | 56 |
| Bulk Api Vendors: | 38 |
| Clinical Trials: | 356 |
| Patent Applications: | 6,441 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for oxycodone hydrochloride |
| DailyMed Link: | oxycodone hydrochloride at DailyMed |
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 |
| (1S,5R,13R,17S)-17-HYDROXY-10-METHOXY-4-METHYL-12-OXA-4-AZAPENTACYCLO[9.6.1.0(1),(1)(3).0?,(1)?.0?,(1)?]OCTADECA-7,9,11(18)-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- |
| Combunox (TN) |
| D00847 |
| D03SKD |
| D05312 |
| D0J0TD |
| D0P6KE |
| DB00497 |
| DEA No. 9143 |
| Dihydro-14-hydroxycodeinone |
| Dihydrohydroxycodeinone |
| Dihydrohydroxycondeinone |
| Dihydrone |
| Dihydrone hydrochloride |
| Dihydrooxycodeinone hydrochloride |
| Dihydroxycodeinone |
| Dihydroxycodeinone hydrochloride |
| Dinarkon |
| Diphydrone |
| DR001354 |
| DTXSID5023407 |
| EINECS 200-960-2 |
| Endine (Australia) |
| Endocet (TN) |
| Endodan (TN) |
| 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, 4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, hydrochloride, (5?)- |
| 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, 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 hydrate |
| 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 |
| Oxycodone/ naloxone controlled release |
| Oxycodonum |
| Oxycodonum [INN-Latin] |
| Oxycon |
| Oxycone |
| Oxycontin |
| Oxycontin (TN) |
| Oxyfast |
| OxyIR |
| oxymorphone 3-methyl ether |
| Oxyneo |
| Oxynorm |
| Pancodine |
| Pancodone Retard |
| Pancodone retard (United Kingdom) |
| Percobarb |
| Percocet (TN) |
| Percodan |
| Percodan (TN) |
| Percolone |
| PF-00345439 |
| PF06 |
| PL069317 |
| PTI-821 |
| Remoxy |
| Roxicet (TN) |
| Roxicodone |
| Roxicodone (TN) |
| Roxiprin (TN) |
| SCHEMBL2737 |
| SCHEMBL30095 |
| Supendol |
| Supendol [Canada] |
| Supeudol |
| Tecodin |
| Tekodin |
| Tekodin (free base) |
| Thecodine |
| Thekodin |
| Theocodin |
| Tylox (TN) |
| UNII-CD35PMG570 |
| WLN: T B6566 B6/CO 4ABBC R BX FV HO PN GHT&&TTJ CQ JO1 P1 |
| Xtampza |
| Xtampza ER |
| ZINC403533 |
Tentative approvals for OXYCODONE HYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 80MG | TABLET, EXTENDED RELEASE; ORAL |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 80MG | TABLET, EXTENDED RELEASE; ORAL |
| ➤ Try a Free Trial | ➤ Try a Free Trial | 40MG | TABLET, EXTENDED RELEASE; ORAL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-002 | Apr 5, 2010 | RX | Yes | No | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Wes Pharma Inc | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 209897-001 | Sep 6, 2017 | AA | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Novel Labs Inc | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | CAPSULE;ORAL | 204752-001 | Aug 24, 2015 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free 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 | 022272-002 | Apr 5, 2010 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-003 | Apr 5, 2010 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-007 | Apr 5, 2010 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for oxycodone hydrochloride
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2016222698 | ➤ Try a Free Trial |
| Hong Kong | 1154788 | ➤ Try a Free Trial |
| Australia | 2009200335 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for oxycodone hydrochloride
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 292 | Luxembourg | ➤ Try a Free 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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