naloxegol Oral Tablet

Brand(s)
Movantik
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2015-01-06)
Oldest Current Product
2015-03-06
License(s)
NDA
RxNORM
ORAL TABLET\NALOXEGOL
FDAOB
ORAL\TABLET\NALOXEGOL OXALATE
SPL Active
ORAL\TABLET, FILM COATED\NALOXEGOL OXALATE
SPL Moiety
ORAL\TABLET, FILM COATED\NALOXEGOL

product(s) by strength(s)

naloxegol 12.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003101969MovantikNDAAstrazeneca Pharmaceuticals Lp2015-03-06NALOXEGOL OXALATEORALTABLET, FILM COATEDNDA204760f49c6978-ca7b-4a66-919b-757f8f92ef64

naloxegol 25 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003101970MovantikNDAAstrazeneca Pharmaceuticals Lp2015-03-06NALOXEGOL OXALATEORALTABLET, FILM COATEDNDA204760f49c6978-ca7b-4a66-919b-757f8f92ef64

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204760MOVANTIKASTRAZENECA PHARMACEUTICALS LP2014-09-16p7056500, TREATMENT OF OPIOID-INDUCED CONSTIPATION, SUBSTANCE
p8067431, TREATMENT OF OPIOID-INDUCED CONSTIPATION
p9012469, SUBSTANCE
p7786133, SUBSTANCE
p8617530, TREATMENT OF OPIOID-INDUCED CONSTIPATION
p7662365, SUBSTANCE
NEW CHEMICAL ENTITY [2019-09-16]NDA204760_001, NDA204760_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204760_001RXNALOXEGOL OXALATE (EQ 12.5MG BASE)ORALTABLETFalse2014-09-16MOVANTIK
2NDA204760_002RXNALOXEGOL OXALATE (EQ 25MG BASE)ORALTABLETTrue2014-09-16MOVANTIK

patent(s)

#idexpiration dateapplication(s)
1p7056500 (view patent)2024-06-29NDA204760
2p7662365 (view patent)2022-10-18NDA204760
3p7786133 (view patent)2027-12-19NDA204760
4p8067431 (view patent)2024-12-16NDA204760
5p8617530 (view patent)2022-10-18NDA204760
6p9012469 (view patent)2032-04-02NDA204760

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1f49c6978-ca7b-4a66-919b-757f8f92ef64 (view SPL)These highlights do not include all the information needed to use MOVANTIK safely and effectively. See full prescribing information for MOVANTIK.MOVANTIK (naloxegol) tablets, for oral useInitial U.S. Approval: 2014prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2015-01-065003101969, 003101970

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII