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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 oxycodone hydrochloride 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, Ascent Pharms Inc, Hi-tech Pharmacal, Pharm Assoc, Specgx Llc, Vistapharm, Wes Pharma Inc, West-ward Pharms Int, Wockhardt Bio Ag, Purdue Pharma Lp, Roxane, Egalet Us Inc, Actavis Elizabeth, Alvogen Malta, Amneal Pharms, Aurolife Pharma Llc, Epic Pharma Llc, Ken Lifescience, Nesher Pharms, Rhodes Pharms, Sun Pharm Inds Inc, Vintage Pharms, and Daiichi Sankyo Inc, and is included in forty-six NDAs. There are twenty-six 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 fifty-three patent family members in forty-seven countries.

There are nineteen drug master file entries for oxycodone hydrochloride. Fifty-eight suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for oxycodone hydrochloride

International Patents:	553
US Patents:	26
Tradenames:	5
Applicants:	29
NDAs:	46
Drug Master File Entries:	19
Suppliers / Packagers:	58
Bulk Api Vendors:	20
Clinical Trials:	356
Patent Applications:	2,564
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for oxycodone hydrochloride
DailyMed Link:	oxycodone hydrochloride at DailyMed

Pharmacology for oxycodone hydrochloride

Drug Class	Opioid Agonist
Mechanism of Action	Full 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

(1S,5R,13R,17S)-17-HYDROXY-10-METHOXY-4-METHYL-12-OXA-4-AZAPENTACYCLO[9.6.1.0(1),(1)(3).0?,(1)?.0?,(1)?]OCTADECA-7,9,11(18)-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-

Combunox (TN)

D00847

D03SKD

D05312

D0J0TD

D0P6KE

DB00497

DEA No. 9143

Dihydro-14-hydroxycodeinone

Dihydrohydroxycodeinone

Dihydrohydroxycondeinone

Dihydrone

Dihydrone hydrochloride

Dihydrooxycodeinone hydrochloride

Dihydroxycodeinone

Dihydroxycodeinone hydrochloride

Dinarkon

Diphydrone

DR001354

DTXSID5023407

EINECS 200-960-2

Endine (Australia)

Endocet (TN)

Endodan (TN)

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, 4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, hydrochloride, (5?)-

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, 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 hydrate

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

Oxycodone/ naloxone controlled release

Oxycodonum

Oxycodonum [INN-Latin]

Oxycon

Oxycone

Oxycontin

Oxycontin (TN)

Oxyfast

OxyIR

oxymorphone 3-methyl ether

Oxyneo

Oxynorm

Pancodine

Pancodone Retard

Pancodone retard (United Kingdom)

Percobarb

Percocet (TN)

Percodan

Percodan (TN)

Percolone

PF-00345439

PF06

PL069317

PTI-821

Remoxy

Roxicet (TN)

Roxicodone

Roxicodone (TN)

Roxiprin (TN)

SCHEMBL2737

SCHEMBL30095

Supendol

Supendol [Canada]

Supeudol

Tecodin

Tekodin

Tekodin (free base)

Thecodine

Thekodin

Theocodin

Tylox (TN)

UNII-CD35PMG570

WLN: T B6566 B6/CO 4ABBC R BX FV HO PN GHT&&TTJ CQ JO1 P1

Xtampza

Xtampza ER

ZINC403533

Tentative approvals for OXYCODONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET, EXTENDED RELEASE; ORAL
		80MG	TABLET, EXTENDED RELEASE; ORAL
		40MG	TABLET, EXTENDED RELEASE; ORAL

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
Vintage Pharms	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	077712-005	Apr 13, 2015	AB	RX	No	No
Sun Pharm Inds Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	090659-001	Apr 10, 2009	AB	RX	No	No
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-006	Apr 5, 2010		RX	Yes	No			Y
Novel Labs Inc	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	TABLET;ORAL	204021-002	Jun 12, 2017	AB	RX	No	No

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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	022272-004	Apr 5, 2010
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-006	Apr 5, 2010
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-001	Apr 5, 2010
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-007	Apr 5, 2010

Non-Orange Book US Patents for oxycodone hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,075,872	Abuse-proofed dosage form
8,114,383	Abuse-proofed dosage form
8,114,384	Process for the production of an abuse-proofed solid dosage form
8,192,722	Abuse-proof dosage form

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International Patents for oxycodone hydrochloride

Country	Document Number	Estimated Expiration
Israel	173558
Ukraine	96306
Norway	339522
European Patent Office	2331080

Supplementary Protection Certificates for oxycodone hydrochloride

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
292	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