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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 204760

Generic Entry Date for 204760^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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	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:	RX	Dosage:	TABLET;ORAL			Strength	EQ 12.5MG BASE
Approval Date:	Sep 16, 2014	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jun 29, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:	⤷ Sign Up	Patent Expiration:	Sep 16, 2028	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Dec 16, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF OPIOID-INDUCED CONSTIPATION

Expired US Patents for NDA 204760

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	204760-001	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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