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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 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 nine patent family members in forty countries.

There are three drug master file entries for naloxegol oxalate. One supplier is listed for this compound.

Summary for naloxegol oxalate

International Patents:	109
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	15
Patent Applications:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for naloxegol oxalate
DailyMed Link:	naloxegol oxalate at DailyMed

Recent Litigation for naloxegol oxalate

Identify potential future generic entrants

PTAB Litigation

Petitioner	Date
Neptune Generics, LLC	2015-10-15

See all naloxegol oxalate litigation

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;oxalic acid

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

65I14TNM33

ACN-053343

AKOS030526444

AZ-13337019 oxalate

AZ13337019 oxalate

CHEMBL2219416

CS-5349

D10375

DTXSID50159395

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-propen-1-yl)-, (5alpha,6alpha)-, ethanedioate (1:1)

Moventig (TN)

Naloxegol (oxalate)

Naloxegol oxalate (USAN)

Naloxegol oxalate [USAN]

Naloxegol Oxalate(NKTR-118)

NKTR-118 oxalate

NKTR-118-oxalate

UNII-65I14TNM33

Paragraph IV (Patent) Challenges for NALOXEGOL OXALATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
MOVANTIK	TABLET;ORAL	naloxegol oxalate	204760	2018-09-17

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	204760-002	Sep 16, 2014		RX	Yes	Yes			Y	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	204760-002	Sep 16, 2014		RX	Yes	Yes			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	204760-001	Sep 16, 2014		RX	Yes	No			Y	Y

International Patents for naloxegol oxalate

Country	Patent Number	Estimated Expiration
New Zealand	609874
Hong Kong	1187248
Uruguay	33643
New Zealand	594834
Eurasian Patent Organization	201000994
Hungary	S1500026
Japan	6034789

Supplementary Protection Certificates for naloxegol oxalate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1694363	2015/024	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
1694363	300737	Netherlands		PRODUCT NAME: NALOXEGOL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER NALOGEXOLOXALAAT; REGISTRATION NO/DATE: EU/1/14/962 20141210
1694363	CA 2015 00028	Denmark		PRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141208
1694363	234 5008-2015	Slovakia		PRODUCT NAME: OXALAT NALOXEGOLU; REGISTRATION NO/DATE: EU/1/14/962 20141210
1694363	C01694363/01	Switzerland		PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: SWISSMEDIC 65205 08.07.2015
1694363	92702	Luxembourg		PRODUCT NAME: NALOXEGOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (MOVENTIG); FIRST REGISTRATION: 20141210
1694363	C300737	Netherlands		PRODUCT NAME: NALOXEGOL ALSMEDE DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/14/962 20141208