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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204760

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NDA 204760 describes MOVANTIK, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the naloxegol oxalate profile page.
Summary for 204760
Tradename:MOVANTIK
Applicant:Astrazeneca Pharms
Ingredient:naloxegol oxalate
Patents:6
Formulation / Manufacturing:see details
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 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 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 0310-1969 0310-1969-39 10 BLISTER PACK in 1 CARTON (0310-1969-39) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 204760
Tradename Dosage Ingredient NDA Submissiondate
MOVANTIK TABLET;ORAL naloxegol oxalate 204760 2018-09-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 12.5MG BASE
Approval Date:Sep 16, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 16, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Jun 29, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:  Start TrialPatent Expiration:Oct 18, 2022Product Flag?YSubstance Flag?YDelist Request?

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