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Last Updated: October 22, 2019

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Oxycodone hydrochloride - Generic Drug Details

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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.

Recent Clinical Trials for oxycodone hydrochloride

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

SponsorPhase
Northwestern UniversityPhase 4
Yale UniversityN/A
Dean EltermanPhase 4

See all oxycodone hydrochloride clinical trials

Recent Litigation for oxycodone hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
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
PetitionerDate
Kashiv Pharma, LLC2018-02-28
Kashiv Pharma, LLC2018-02-27
Amneal Pharmaceuticals, LLC2016-05-11

See all oxycodone hydrochloride litigation

Generic filers with tentative approvals for OXYCODONE HYDROCHLORIDE
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 hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull 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

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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Serving leading biopharmaceutical companies globally:

Moodys
Mallinckrodt
Boehringer Ingelheim
Express Scripts
Colorcon
Harvard Business School

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.