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Last Updated: May 24, 2022

Details for New Drug Application (NDA): 204760


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NDA 204760 describes MOVANTIK, which is a drug marketed by Redhill and is included in one NDA. It is available from three suppliers. There are six 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:Redhill
Ingredient:naloxegol oxalate
Patents:6
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity 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 Action Opioid 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 AstraZeneca Pharmaceuticals LP 0310-1969 0310-1969-30 30 TABLET, FILM COATED in 1 BOTTLE (0310-1969-30)
MOVANTIK naloxegol oxalate TABLET;ORAL 204760 NDA AstraZeneca Pharmaceuticals LP 0310-1970 0310-1970-30 30 TABLET, FILM COATED in 1 BOTTLE (0310-1970-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12.5MG BASE
Approval Date:Sep 16, 2014TE:RLD:Yes
Patent:See Plans and PricingPatent Expiration:Jun 29, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:See Plans and PricingPatent Expiration:Oct 18, 2022Product Flag?YSubstance Flag?YDelist Request?
Patent:See Plans and PricingPatent Expiration:Sep 16, 2028Product Flag?YSubstance Flag?YDelist Request?

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