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Oxycodone - Generic Drug Details
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What are the generic drug sources for oxycodone and what is the scope of patent protection?
Oxycodone
is the generic ingredient in six branded drugs marketed by Collegium Pharm Inc, Ani Pharms Inc, Avanthi Inc, Genus Lifesciences, Lannett Co Inc, Mayne Pharma Inc, Novel Labs Inc, Abhai Llc, Alkem Labs Ltd, Ascent Pharms Inc, Eywa, Hi Tech, Hikma, Pharm Assoc, Specgx Llc, Vistapharm, 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 Inspirion Delivery, and is included in fifty NDAs. There are forty-five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Oxycodone has twenty-four patent family members in thirteen countries.
There are nineteen drug master file entries for oxycodone. One supplier is listed for this compound. There are four tentative approvals for this compound.
Summary for oxycodone
| International Patents: | 24 |
| US Patents: | 45 |
| Tradenames: | 6 |
| Applicants: | 31 |
| NDAs: | 50 |
| Drug Master File Entries: | 19 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 19 |
| Clinical Trials: | 451 |
| Patent Applications: | 6,884 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for oxycodone |
| Drug Sales Revenues: | Drug sales revenues for oxycodone |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for oxycodone |
| DailyMed Link: | oxycodone at DailyMed |
Recent Clinical Trials for oxycodone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chen Wannan | Phase 4 |
| Camille Ladanyi MD | N/A |
| Northwestern University | Phase 4 |
Recent Litigation for oxycodone
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA, Inc. | 2018-02-22 |
| Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc. | 2016-11-30 |
| Cornerstone Biopharma Inc. v. Exela Pharma Sciences LLC | 2013-07-24 |
Generic filers with tentative approvals for OXYCODONE
| 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
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for oxycodone
Synonyms for oxycodone
| (-)-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 |
| (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-Hydroxydihydrocodeinone |
| 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 |
| 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 |
| AN-22961 |
| Apo-oxycodone CR |
| Avridi |
| BDBM50370595 |
| BRN 0043446 |
| BRUQQQPBMZOVGD-XFKAJCMBSA-N |
| C08018 |
| CD35PMG570 |
| CHEBI:7852 |
| CHEMBL656 |
| Codeinone, 7,8-dihydro-14-hydroxy- |
| Codeinone, dihydro-14-hydroxy- |
| Codeinone, dihydrohydroxy- |
| Codeinone,8-dihydro-14-hydroxy- |
| D05312 |
| DB00497 |
| DEA No. 9143 |
| Dihydro-14-hydroxycodeinone |
| Dihydrohydroxycodeinone |
| Dihydrohydroxycondeinone |
| Dihydrone |
| Dihydroxycodeinone |
| Diphydrone |
| DTXSID5023407 |
| EINECS 200-960-2 |
| Endine (Australia) |
| Endone |
| Eubine |
| Eubine [France] |
| Eucodal |
| Eucodalum |
| Eukodal |
| Eutagen |
| 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- |
| NSC 19043 |
| NSC-19043 |
| NSC19043 |
| Ossicodone |
| Ossicodone [DCIT] |
| Oxanest |
| Oxicodona |
| Oxicodona [INN-Spanish] |
| Oxicon |
| Oxicone |
| Oxiconum |
| Oxikon |
| Oxycodeinon |
| Oxycodeinone |
| Oxycodon |
| Oxycodone (USAN/INN) |
| Oxycodone [USAN:INN:BAN] |
| Oxycodone 0.1 mg/ml in Methanol |
| Oxycodone 1.0 mg/ml in Methanol |
| Oxycodone Concentrate |
| Oxycodone hydrochloride |
| Oxycodone solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material |
| Oxycodonum |
| Oxycodonum [INN-Latin] |
| Oxycon |
| Oxycone |
| Oxycontin |
| Oxyfast |
| OxyIR |
| Oxyneo |
| Pancodine |
| Pancodone Retard |
| Pancodone retard (United Kingdom) |
| Percobarb |
| Percodan |
| Percolone |
| PF-00345439 |
| PF06 |
| PTI-821 |
| Roxicodone |
| SCHEMBL2737 |
| 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 |
Paragraph IV (Patent) Challenges for OXYCODONE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| XTAMPZA ER | CAPSULE, EXTENDED RELEASE;ORAL | oxycodone | 208090 | 2017-11-15 |
US Patents and Regulatory Information for oxycodone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specgx Llc | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | SOLUTION;ORAL | 210758-002 | Apr 30, 2018 | AA | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-006 | Apr 5, 2010 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-001 | Apr 5, 2010 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Aurolife Pharma Llc | OXYCODONE HYDROCHLORIDE | oxycodone hydrochloride | TABLET;ORAL | 202160-003 | Nov 19, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Collegium Pharm Inc | XTAMPZA ER | oxycodone | CAPSULE, EXTENDED RELEASE;ORAL | 208090-002 | Apr 26, 2016 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-002 | 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 |
International Patents for oxycodone
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2013216707 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2005123039 | Start Trial |
| European Patent Office | 1765292 | Start Trial |
| Japan | 4694207 | Start Trial |
| Denmark | 1765292 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2017222575 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for oxycodone
| 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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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2020, www.DrugPatentWatch.com.