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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 oxycodone 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, Hi Tech, Pharm Assoc, Specgx Llc, Vistapharm, Wes Pharma Inc, West-ward Pharms Int, Wockhardt Bio Ag, Purdue Pharma Lp, Roxane, Egalet, Actavis Elizabeth, Alvogen Malta, 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 fifty NDAs. There are forty-three 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. Two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for oxycodone

International Patents:	24
US Patents:	43
Tradenames:	6
Applicants:	31
NDAs:	50
Drug Master File Entries:	19
Suppliers / Packagers:	2
Bulk Api Vendors:	19
Clinical Trials:	440
Patent Applications:	6,856
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

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

Generic filers with tentative approvals for OXYCODONE

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET, EXTENDED RELEASE; ORAL
		80MG	TABLET, EXTENDED RELEASE; ORAL
		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.

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
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016		RX	Yes	No			Y
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010		RX	Yes	No			Y	Y
Vintage Pharms	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	077712-003	Mar 2, 2009		DISCN	No	No
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-001	Apr 26, 2016		RX	Yes	No			Y
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016		RX	Yes	No
Abhai Llc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	208593-002	Jul 21, 2017	AA	RX	No	No

International Patents for oxycodone

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005123039
Japan	2006500426
Canada	2916869
Slovenia	1765292
Hungary	E037643
European Patent Office	3326617

Supplementary Protection Certificates for oxycodone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg		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