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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. 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 two 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:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	21
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			Y	Y
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
Astrazeneca Pharms	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes			Y	Y

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Non-Orange Book US Patents for naloxegol oxalate

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
8,349,307	Polymer conjugates of opioid antagonists
2,015,197,470
8,034,825	Chemically modified small molecules
9,388,104	Chemically modified small molecules

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International Patents for naloxegol oxalate

Country	Document Number	Estimated Expiration
Israel	176317
South Korea	101791724
Australia	2014280956
Japan	2005506351

Supplementary Protection Certificates for naloxegol oxalate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
4 5008-2015	Slovakia		PRODUCT NAME: OXALAT NALOXEGOLU; REGISTRATION NO/DATE: EU/1/14/962 20141210
2015 00028	Denmark		PRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210
702	Luxembourg		PRODUCT NAME: NALOXEGOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (MOVENTIG); FIRST REGISTRATION: 20141210
2015019,C1694363	Lithuania		PRODUCT NAME: NALOKSEGOLAS, KONKRECIAI NALOKSEGOLO OKSALATO DRUSKA; REGISTRATION NO/DATE: EU/1/14/962 20141208