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Last Updated: March 4, 2021

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Naloxegol oxalate - Generic Drug Details

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What are the generic drug sources for naloxegol oxalate and what is the scope of patent protection?

Naloxegol oxalate is the generic ingredient in one branded drug marketed by Redhill 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 twelve patent family members in forty-one countries.

There are three drug master file entries for naloxegol oxalate. Three suppliers are listed for this compound.

Summary for naloxegol oxalate
Recent Clinical Trials for naloxegol oxalate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Institut Paoli-CalmettesPhase 2

See all naloxegol oxalate clinical trials

Pharmacology for naloxegol oxalate
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
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
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 204760-002 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   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 204760-002 Sep 16, 2014 RX Yes Yes   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 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
1694363 PA2015019,C1694363 Lithuania   Start Trial PRODUCT NAME: NALOKSEGOLAS, KONKRECIAI NALOKSEGOLO OKSALATO DRUSKA; 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 592 Finland   Start Trial
1694363 15C0037 France   Start 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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