Details for New Drug Application (NDA): 022341

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NDA 022341 describes VICTOZA, which is a drug marketed by Novo Nordisk Inc 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 VICTOZA profile page.

The generic ingredient in VICTOZA is liraglutide. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the liraglutide profile page.

Summary for 022341

Tradename:	VICTOZA
Applicant:	Novo Nordisk Inc
Ingredient:	liraglutide
Patents:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022341

Generic Entry Date for 022341^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 8,114,833PED Dosage:* SOLUTION;SUBCUTANEOUS

^*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: 022341

Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

Suppliers and Packaging for NDA: 022341

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341	NDA	Novo Nordisk	0169-4060	0169-4060-12	2 SYRINGE, PLASTIC in 1 CARTON (0169-4060-12) / 3 mL in 1 SYRINGE, PLASTIC
VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341	NDA	Novo Nordisk	0169-4060	0169-4060-13	3 SYRINGE, PLASTIC in 1 CARTON (0169-4060-13) / 3 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	18MG/3ML (6MG/ML)
Approval Date:	Jan 25, 2010	TE:		RLD:	Yes
Patent:	7,762,994*PED	Patent Expiration:	Nov 23, 2024	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	8,114,833*PED	Patent Expiration:	Feb 13, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	9,265,893*PED	Patent Expiration:	Mar 23, 2033	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 022341

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	RE41956*PED	⤷ Subscribe
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	6,004,297	⤷ Subscribe
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	RE43834	⤷ Subscribe
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	7,235,627	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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