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Naloxegol oxalate - Generic Drug Details

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 eight patent family members in thirty-nine countries.

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

Summary for naloxegol oxalate

International Patents:	108
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	3
Suppliers / Packagers:	2
Bulk Api Vendors:	15
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;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

US Patents and Regulatory Information for naloxegol oxalate

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Glossary

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

International Patents for naloxegol oxalate

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Country	Patent Number	Estimated Expiration
Denmark	1436012	➤ Sign Up
Argentina	083268	➤ Sign Up
Lithuania	C1694363	➤ Sign Up
Country	Patent Number	Estimated Expiration

Supplementary Protection Certificates for naloxegol oxalate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1694363	92702	Luxembourg	➤ Sign Up	PRODUCT NAME: NALOXEGOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (MOVENTIG); FIRST REGISTRATION: 20141210
1694363	C01694363/01	Switzerland	➤ Sign Up	PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: SWISSMEDIC 65205 08.07.2015
1694363	27/2015	Austria	➤ Sign Up	PRODUCT NAME: NALOXEGOL, GEGEBENENFALLS IN FORM EINES THERAPEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE ALS OXALAT; REGISTRATION NO/DATE: EU/1/14/962 20141208
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description