MOVANTIK Drug Patent Profile

Which patents cover Movantik, and when can generic versions of Movantik launch?

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

This drug has one hundred and fifteen patent family members in forty-two 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.

DrugPatentWatch^® Generic Entry Outlook for Movantik

Movantik was eligible for patent challenges on September 16, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 2, 2032. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for MOVANTIK

International Patents:	115
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	14
Patent Applications:	145
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MOVANTIK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOVANTIK
What excipients (inactive ingredients) are in MOVANTIK?	MOVANTIK excipients list
DailyMed Link:	MOVANTIK at DailyMed

See drug prices for MOVANTIK

DrugPatentWatch^® Estimated 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.

Recent Clinical Trials for MOVANTIK

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Missouri-Columbia	Phase 4
University of Tennessee, Chattanooga	N/A
Camille Ladanyi MD	N/A

See all MOVANTIK clinical trials

Pharmacology for MOVANTIK

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for MOVANTIK

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for MOVANTIK

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOVANTIK	Tablets	naloxegol oxalate	12.5 mg and 25 mg	204760	2	2018-09-17

US Patents and Regulatory Information for MOVANTIK

MOVANTIK is protected by six US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting MOVANTIK

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

Expired US Patents for MOVANTIK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Redhill	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014
Redhill	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014
Redhill	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-001	Sep 16, 2014
Redhill	MOVANTIK	naloxegol oxalate	TABLET;ORAL	204760-002	Sep 16, 2014

International Patents for MOVANTIK

When does loss-of-exclusivity occur for MOVANTIK?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Malaysia

Mexico

Montenegro

New Zealand

Nicaragua

Peru

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MOVANTIK around the world.

Country	Patent Number	Title	Estimated Expiration
Peru	20140636	CONJUGADO DE NALOXOL-PEG CRISTALINO
South Korea	100974842
Hungary	S1500026
Spain	2817799
Japan	2007514761
Spain	2819305

Supplementary Protection Certificates for MOVANTIK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1694363	C 2015 022	Romania		PRODUCT NAME: NALOXEGOL SI SARURILE SALE ACCEPTABILE FARMACEUTIC, IN SPECIAL SAREA OXALAT A NALOXEGOLULUI; NATIONAL AUTHORISATION NUMBER: EU/1/14/962; DATE OF NATIONAL AUTHORISATION: 20141208; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/962; DATE OF FIRST AUTHORISATION IN EEA: 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	122015000037	Germany		PRODUCT NAME: NALOXEGOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/962 20141208
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	CR 2015 00028	Denmark		PRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210
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