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Last Updated: December 2, 2022

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 fifteen patent family members in forty-two countries.

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

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 Action Opioid 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
Redhill MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Redhill MOVANTIK naloxegol oxalate TABLET;ORAL 204760-001 Sep 16, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Redhill MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Redhill MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 See Plans and Pricing See Plans and Pricing
Redhill MOVANTIK naloxegol oxalate TABLET;ORAL 204760-001 Sep 16, 2014 See Plans and Pricing See Plans and Pricing
Redhill MOVANTIK naloxegol oxalate TABLET;ORAL 204760-002 Sep 16, 2014 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for naloxegol oxalate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1694363 PA2015019,C1694363 Lithuania See Plans and Pricing PRODUCT NAME: NALOKSEGOLAS, KONKRECIAI NALOKSEGOLO OKSALATO DRUSKA; REGISTRATION NO/DATE: EU/1/14/962 20141208
1694363 592 Finland See Plans and Pricing
1694363 C01694363/01 Switzerland See Plans and Pricing PRODUCT NAME: NALOXEGOLUM; REGISTRATION NO/DATE: SWISSMEDIC 65205 08.07.2015
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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