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Last Updated: November 16, 2019

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Oxycodone - Generic Drug Details

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

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, Pharm Assoc, Specgx Llc, Vistapharm, 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 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.

Drug Prices for oxycodone

See drug prices for oxycodone

Drug Sales Revenue Trends for oxycodone

See drug sales revenues for oxycodone

Recent Clinical Trials for oxycodone

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Camille Ladanyi MDN/A
Northwestern UniversityPhase 4
The Methodist Hospital SystemPhase 1

See all oxycodone clinical trials

Recent Litigation for oxycodone

Identify potential future generic entrants

District Court Litigation
Case NameDate
Collegium Pharmaceutical, Inc. v. Teva Pharmaceuticals USA, Inc.2018-02-22
Cornerstone Biopharma Inc. v. Exela Pharma Sciences LLC2013-07-24

See all oxycodone litigation

Generic filers with tentative approvals for OXYCODONE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial80MGTABLET, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial80MGTABLET, EXTENDED RELEASE; ORAL
  Start Trial  Start Trial40MGTABLET, 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 ClassOpioid Agonist
Mechanism of ActionFull 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
Epic Pharma Llc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 202662-003 Sep 22, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Ascent Pharms Inc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 207418-001 Aug 7, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Specgx Llc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 076758-003 Mar 19, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Zyla OXAYDO oxycodone hydrochloride TABLET;ORAL 202080-001 Jun 17, 2011 RX No No   Start Trial   Start Trial Y   Start Trial
Mayne Pharma Inc OXYCODONE HYDROCHLORIDE oxycodone hydrochloride TABLET;ORAL 091313-004 Apr 29, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-003 Apr 26, 2016 RX Yes 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

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.