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Last Updated: January 23, 2020

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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 ten patent family members in forty countries.

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

See drug prices for MOVANTIK

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

Recent Litigation for MOVANTIK

Identify potential future generic entrants

PTAB Litigation
PetitionerDate
Neptune Generics, LLC2015-10-15

See all MOVANTIK litigation

Pharmacology for MOVANTIK
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid 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
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
Astrazeneca Pharms MOVANTIK naloxegol oxalate TABLET;ORAL 204760-001 Sep 16, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms MOVANTIK naloxegol oxalate TABLET;ORAL 204760-001 Sep 16, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms 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 PA2015019 Lithuania   Start Trial PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363 C300737 Netherlands   Start Trial PRODUCT NAME: NALOXEGOL ALSMEDE DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363 27/2015 Austria   Start Trial 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
McKinsey
Moodys
Boehringer Ingelheim
McKesson

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