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MOVANTIK Drug Profile

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When do Movantik patents expire, and when can generic versions of Movantik launch?

Movantik is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and six patent family members in thirty-seven countries.

The generic ingredient in MOVANTIK is naloxegol oxalate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the naloxegol oxalate profile page.

Summary for MOVANTIK

International Patents:	106
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	9
Clinical Trials:	12
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MOVANTIK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOVANTIK
DailyMed Link:	MOVANTIK at DailyMed

Generic Entry Opportunity Date for MOVANTIK

NDA:

204760

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for MOVANTIK

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Synonyms for MOVANTIK

(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

44T7335BKE

854601-70-0

AKOS030526932

AZ-13337019

AZ13337019

CHEBI:82975

CHEMBL2219418

CS-4987

D10479

DB09049

DTXSID80234684

GTPL7539

HSDB 8338

HY-A0118

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

moventig

Naloxegol

Naloxegol (USAN/INN)

Naloxegol [USAN:INN]

NKTR 118

NKTR-118

NKTR118

SCHEMBL19433066

UNII-44T7335BKE

ZINC95564694

US Patents and Regulatory Information for MOVANTIK

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			Y	Y
Astrazeneca Pharms	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No
Astrazeneca Pharms	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014		RX	Yes	No			Y
Astrazeneca Pharms	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014		RX	Yes	Yes

Paragraph IV (Patent) Challenges for MOVANTIK

Drugname	Dosage	Strength	RLD	Date
	Tablets	12.5 mg and 25 mg

International Patents for MOVANTIK

Country	Patent Number	Estimated Expiration
Hong Kong	1146645
Slovenia	1694363
Israel	176317
Ecuador	SP13012531

Supplementary Protection Certificates for MOVANTIK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1694363	15C0037	France		PRODUCT NAME: NALOXEGOL OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES,EN PARTICULIER L'OXALATE DE NALOXEGOL; REGISTRATION NO/DATE: EU/1/14/962 20141210
1694363	CR 2015 00028	Denmark		PRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210
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	234 5008-2015	Slovakia		PRODUCT NAME: OXALAT NALOXEGOLU; REGISTRATION NO/DATE: EU/1/14/962 20141210