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Last Updated: June 14, 2024

Details for New Drug Application (NDA): 204760


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NDA 204760 describes MOVANTIK, which is a drug marketed by Valinor and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MOVANTIK profile page.

The generic ingredient in MOVANTIK is naloxegol oxalate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxegol oxalate profile page.
Summary for 204760
Tradename:MOVANTIK
Applicant:Valinor
Ingredient:naloxegol oxalate
Patents:4
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 204760
Generic Entry Date for 204760*:
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.

Pharmacology for NDA: 204760
Mechanism of ActionOpioid Antagonists
Suppliers and Packaging for NDA: 204760
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOVANTIK naloxegol oxalate TABLET;ORAL 204760 NDA Quality Care Products, LLC 55700-988 55700-988-30 30 TABLET, FILM COATED in 1 BOTTLE (55700-988-30)
MOVANTIK naloxegol oxalate TABLET;ORAL 204760 NDA RedHill Biopharma Ltd 57841-1300 57841-1300-1 30 TABLET, FILM COATED in 1 BOTTLE (57841-1300-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12.5MG BASE
Approval Date:Sep 16, 2014TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jun 29, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:⤷  Sign UpPatent Expiration:Sep 16, 2028Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Dec 16, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION

Expired US Patents for NDA 204760

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

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