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Last Updated: May 19, 2024

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MOVANTIK Drug Patent Profile


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

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

This drug has one hundred and sixteen patent family members in forty-four countries.

The generic ingredient in MOVANTIK is naloxegol oxalate. There are three drug master file entries for this compound. Three 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

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Drug patent expirations by year for MOVANTIK
Drug Prices for MOVANTIK

See drug prices for MOVANTIK

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MOVANTIK
Generic Entry Date for MOVANTIK*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
University of Missouri-ColumbiaPhase 4
Camille Ladanyi MDN/A
University of Tennessee, ChattanoogaN/A

See all MOVANTIK clinical trials

Pharmacology for MOVANTIK
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
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 four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MOVANTIK is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Polymer conjugates of opioid antagonists
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION

Chemically modified small molecules
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Chemically modified small molecules
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION

Crystalline naloxol-peg conjugate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Expired US Patents for MOVANTIK

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 ⤷  Try a Trial ⤷  Try a Trial
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-001 Sep 16, 2014 ⤷  Try a Trial ⤷  Try a Trial
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 ⤷  Try a Trial ⤷  Try a Trial
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-001 Sep 16, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Patent: 3268
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 11307608
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2013007113
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 12649
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 13000866
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3237547
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 00851
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 130146
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0151420
Estimated Expiration: ⤷  Try a Trial

Cuba

Patent: 317
Estimated Expiration: ⤷  Try a Trial

Patent: 130047
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 17376
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 21496
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 13012531
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 3929
Estimated Expiration: ⤷  Try a Trial

Patent: 1300423
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 21496
Estimated Expiration: ⤷  Try a Trial

Patent: 92903
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 1300084
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 87248
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 26726
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 34789
Estimated Expiration: ⤷  Try a Trial

Patent: 13538849
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 3890
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 13003587
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 313
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 9874
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 1300034
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 140636
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 21496
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 21496
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 01600004
Estimated Expiration: ⤷  Try a Trial

Saudi Arabia

Patent: 1320808
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 488
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 8474
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 21496
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1791724
Estimated Expiration: ⤷  Try a Trial

Patent: 130135844
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 62643
Estimated Expiration: ⤷  Try a Trial

Patent: 19305
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 18088
Estimated Expiration: ⤷  Try a Trial

Patent: 1307356
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 2847
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 643
Estimated Expiration: ⤷  Try a Trial

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
Denmark 1436012 ⤷  Try a Trial
Japan 2007514761 ⤷  Try a Trial
Hong Kong 1210418 單分散性聚乙二醇化納洛醇組合物 (MONODISPERSE PEGYLATED NALOXOL COMPOSITIONS) ⤷  Try a Trial
France 15C0037 ⤷  Try a Trial
Poland 1694363 ⤷  Try a Trial
Spain 2569262 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MOVANTIK

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1694363 92702 Luxembourg ⤷  Try a Trial PRODUCT NAME: NALOXEGOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (MOVENTIG); FIRST REGISTRATION: 20141210
1694363 C01694363/01 Switzerland ⤷  Try a Trial PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: SWISSMEDIC 65205 08.07.2015
1694363 27/2015 Austria ⤷  Try a Trial PRODUCT NAME: NALOXEGOL, GEGEBENENFALLS IN FORM EINES THERAPEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE ALS OXALAT; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363 15C0037 France ⤷  Try a Trial 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 592 Finland ⤷  Try a Trial
1694363 PA2015019,C1694363 Lithuania ⤷  Try a Trial PRODUCT NAME: NALOKSEGOLAS, KONKRECIAI NALOKSEGOLO OKSALATO DRUSKA; REGISTRATION NO/DATE: EU/1/14/962 20141208
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.