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Naloxegol oxalate - Generic Drug Details

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

Naloxegol oxalate is the generic ingredient in one branded drug marketed by Astrazeneca Pharms and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Naloxegol oxalate has one hundred and two patent family members in thirty-seven countries.

There are three drug master file entries for naloxegol oxalate. Two suppliers are listed for this compound.

Summary for naloxegol oxalate

International Patents:	102
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Suppliers / Packagers:	2
Bulk Api Vendors:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naloxegol oxalate
DailyMed Link:	naloxegol oxalate at DailyMed

Pharmacology for naloxegol oxalate

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Synonyms for naloxegol oxalate

(4R,4aS,7S,7aR,12bS)-7-[2-[2-[2-[2-[2-[2-(2-methoxyethoxy)ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]ethoxy]-3-prop-2-enyl-1,2,4,5,6,7,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinoline-4a,9-diol

(5alpha,6alpha)-17-Allyl-6-[(20-hydroxy-3,6,9,12,15,18-hexaoxaicos-1-yl)oxy]-4,5-epoxymorphinan-3,14-diol

1354744-91-4

4,5alpha-epoxy-6alpha-((3,6,7,12,15,18,21-Heptaoxadocosyl)oxy)-17-(prop-2-enyl)morphinan-3,14-diol hydrogen ethanedioate

44T7335BKE

65I14TNM33

854601-70-0

AKOS030526444

AKOS030526932

AZ-13337019

AZ-13337019 oxalate

AZ13337019

AZ13337019 oxalate

CHEBI:82975

CHEMBL2219416

CHEMBL2219418

CS-4987

CS-5349

D07LCF

D10375

D10479

DB09049

DTXSID50159395

DTXSID80234684

GTPL7539

HSDB 8338

HY-A0118

HY-A0118A

MolPort-046-033-545

Morphinan-3,14-diol, 4,5-epoxy-6-(3,6,9,12,15,18,21-heptaoxadocos-1-yloxy)- 17-(2-propenyl)-, (5alpha,6alpha)-

Morphinan-3,14-diol, 4,5-epoxy-6-(3,6,9,12,15,18,21-heptaoxadocos-1-yloxy)-17-(2-propen-1-yl)-, (5alpha,6alpha)-, ethanedioate (1:1)

Movantik

moventig

Moventig (TN)

Naloxegol

Naloxegol (oxalate)

Naloxegol (USAN/INN)

Naloxegol [USAN:INN]

Naloxegol oxalate (USAN)

Naloxegol oxalate [USAN]

Naloxegol Oxalate(NKTR-118)

NKTR 118

NKTR-118

NKTR-118 oxalate

NKTR-118-oxalate

NKTR118

SCHEMBL19433066

UNII-44T7335BKE

UNII-65I14TNM33

ZINC95564694

US Patents and Regulatory Information for naloxegol oxalate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Pharms	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes
Astrazeneca Pharms	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No			Y
Astrazeneca Pharms	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No			Y	Y
Astrazeneca Pharms	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No
Astrazeneca Pharms	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes
Astrazeneca Pharms	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No

International Patents for naloxegol oxalate

Country	Document Number	Estimated Expiration
Eurasian Patent Organization	018427
South Korea	20050037423
Slovenia	2939696
Guatemala	201300084
Spain	2569262
New Zealand	583573

Supplementary Protection Certificates for naloxegol oxalate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
15/024	Ireland		PRODUCT NAME: NALOXEGOL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE OXALATE SALT OF THE ALPHA-EPIMER OF NALOXEGOL; REGISTRATION NO/DATE: EU/1/14/962 20141208
2015019	Lithuania		PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: EU/1/14/962 20141208
00737	Netherlands		PRODUCT NAME: NALOXEGOL ALSMEDE DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/14/962 20141208
/2015	Austria		PRODUCT NAME: NALOXEGOL, GEGEBENENFALLS IN FORM EINES THERAPEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE ALS OXALAT; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363/01	Switzerland		PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: SWISSMEDIC 65205 08.07.2015
90027-7	Sweden		PRODUCT NAME: NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210