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Last Updated: November 16, 2019

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Naloxegol oxalate - Generic Drug Details

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What are the generic sources for naloxegol oxalate and what is the scope of freedom to operate?

Naloxegol oxalate is the generic ingredient in one branded drug marketed by Astrazeneca Pharms and is included in one NDA. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Naloxegol oxalate has one hundred and nine patent family members in forty countries.

There are three drug master file entries for naloxegol oxalate. One supplier is listed for this compound.

Recent Litigation for naloxegol oxalate

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PTAB Litigation
PetitionerDate
Neptune Generics, LLC2015-10-15

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Pharmacology for naloxegol oxalate
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Synonyms for naloxegol oxalate
(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;oxalic acid
1354744-91-4
4,5alpha-epoxy-6alpha-((3,6,7,12,15,18,21-Heptaoxadocosyl)oxy)-17-(prop-2-enyl)morphinan-3,14-diol hydrogen ethanedioate
65I14TNM33
ACN-053343
AKOS030526444
AZ-13337019 oxalate
AZ13337019 oxalate
CHEMBL2219416
CS-5349
D10375
DTXSID50159395
HY-A0118A
MolPort-046-033-545
Morphinan-3,14-diol, 4,5-epoxy-6-(3,6,9,12,15,18,21-heptaoxadocos-1-yloxy)-17-(2-propen-1-yl)-, (5alpha,6alpha)-, ethanedioate (1:1)
Moventig (TN)
Naloxegol (oxalate)
Naloxegol oxalate (USAN)
Naloxegol oxalate [USAN]
Naloxegol Oxalate(NKTR-118)
NKTR-118 oxalate
NKTR-118-oxalate
UNII-65I14TNM33
Paragraph IV (Patent) Challenges for NALOXEGOL OXALATE
Tradename Dosage Ingredient NDA Submissiondate
MOVANTIK TABLET;ORAL naloxegol oxalate 204760 2018-09-17

US Patents and Regulatory Information for naloxegol oxalate

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 204760-002 Sep 16, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 RX Yes Yes   Start Trial   Start Trial Y Y   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
Astrazeneca Pharms MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Pharms MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 RX Yes Yes   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 naloxegol oxalate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1694363 2015/024 Ireland   Start Trial 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 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 CA 2015 00028 Denmark   Start Trial PRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141208
1694363 234 5008-2015 Slovakia   Start Trial PRODUCT NAME: OXALAT NALOXEGOLU; REGISTRATION NO/DATE: EU/1/14/962 20141210
1694363 C01694363/01 Switzerland   Start Trial PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: SWISSMEDIC 65205 08.07.2015
1694363 92702 Luxembourg   Start Trial PRODUCT NAME: NALOXEGOL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (MOVENTIG); FIRST REGISTRATION: 20141210
1694363 C300737 Netherlands   Start Trial PRODUCT NAME: NALOXEGOL ALSMEDE DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/14/962 20141208
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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