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Last Updated: December 7, 2019

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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, 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.

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:	447
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

See drug prices for oxycodone

See drug sales revenues for oxycodone

Recent Clinical Trials for oxycodone

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

Sponsor	Phase
Camille Ladanyi MD	N/A
Northwestern University	Phase 4
Yale University	N/A

See all oxycodone clinical trials

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
Cornerstone Biopharma Inc. v. Exela Pharma Sciences LLC	2013-07-24

See all oxycodone litigation

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

Analgesics, Opioid
Narcotics

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

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Glossary

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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	022272-006	Apr 5, 2010		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-001	Jun 17, 2011		RX	No	No	Start Trial	Start Trial	Y			Start Trial
Ascent Pharms Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	209021-002	Nov 9, 2017	AA	RX	No	No	Start Trial	Start Trial				Start Trial
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016		RX	Yes	Yes	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
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016		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

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004004693	Start Trial
Japan	2015166402	Start Trial
European Patent Office	1765292	Start Trial
Denmark	1765292	Start Trial
European Patent Office	1594467	Start Trial
Canada	2916869	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for oxycodone

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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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