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Last Updated: January 25, 2021

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MOVANTIK Drug Profile

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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 twelve patent family members in forty-one 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.

US ANDA Litigation and 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 is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for MOVANTIK
Drug Prices for MOVANTIK

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Generic Entry Opportunity 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
Camille Ladanyi MDN/A
University of Missouri-ColumbiaPhase 4
Angela FellnerPhase 2/Phase 3

See all MOVANTIK clinical trials

Pharmacology for MOVANTIK
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Paragraph IV (Patent) Challenges for MOVANTIK
Tradename Dosage Ingredient NDA Submissiondate
MOVANTIK TABLET;ORAL naloxegol oxalate 204760 2018-09-17

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

Supplementary Protection Certificates for MOVANTIK

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1694363 1590027-7 Sweden   Start Trial PRODUCT NAME: NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210
1694363 234 5008-2015 Slovakia   Start Trial PRODUCT NAME: OXALAT NALOXEGOLU; REGISTRATION NO/DATE: EU/1/14/962 20141210
1694363 122015000037 Germany   Start Trial PRODUCT NAME: NALOXEGOL ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363 300737 Netherlands   Start Trial 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 592 Finland   Start Trial
1694363 C01694363/01 Switzerland   Start Trial PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: SWISSMEDIC 65205 08.07.2015
1694363 PA2015019,C1694363 Lithuania   Start 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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