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Last Updated: March 28, 2024

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 Valinor and is included in one NDA. There are four 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 sixteen patent family members in forty-four countries.

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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for naloxegol oxalate
Generic Entry Date for naloxegol oxalate*:
Constraining patent/regulatory exclusivity:
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 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 Strength NDA ANDAs Submitted Submissiondate
MOVANTIK Tablets naloxegol oxalate 12.5 mg and 25 mg 204760 2 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
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-001 Sep 16, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-001 Sep 16, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for naloxegol oxalate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-001 Sep 16, 2014 ⤷  Try a Trial ⤷  Try a Trial
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 ⤷  Try a Trial ⤷  Try a Trial
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 ⤷  Try a Trial ⤷  Try a Trial
Valinor MOVANTIK naloxegol oxalate TABLET;ORAL 204760-001 Sep 16, 2014 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for naloxegol oxalate

Country Patent Number Title Estimated Expiration
Slovenia 2939696 ⤷  Try a Trial
New Zealand 583573 Pegylated naloxol ⤷  Try a Trial
Slovenia 2621496 ⤷  Try a Trial
Mexico PA04003597 CONJUGADOS POLIMERICOS DE ANTAGONISTAS OPIACEOS. (POLYMER CONJUGATES OF OPIOID ANTAGONISTS.) ⤷  Try a Trial
Lithuania C1694363 ⤷  Try a Trial
Eurasian Patent Organization 015333 КОМПОЗИЦИИ, СОДЕРЖАЩИЕ КОНЪЮГАТЫ, СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЕ (COMPOSITIONS COMPRISING CONJUGATES, METHODS FOR PRODUCING THEREOF AND USE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for naloxegol oxalate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1694363 27/2015 Austria ⤷  Try a Trial PRODUCT NAME: NALOXEGOL, GEGEBENENFALLS IN FORM EINES THERAPEUTISCH VERTRAEGLICHEN SALZES, INSBESONDERE ALS OXALAT; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363 CA 2015 00028 Denmark ⤷  Try a Trial PRODUCT NAME: OXYLATSALT AF NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141208
1694363 C300737 Netherlands ⤷  Try a Trial PRODUCT NAME: NALOXEGOL ALSMEDE DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363 1590027-7 Sweden ⤷  Try a Trial PRODUCT NAME: NALOXEGOL; REG. NO/DATE: EU/1/14/962 20141210
1694363 SPC/GB15/026 United Kingdom ⤷  Try a Trial PRODUCT NAME: NALOXEGOL OXALATE; REGISTERED: UK EU/1/14/962/001-011 20141210
1694363 300737 Netherlands ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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