Details for New Drug Application (NDA): 206321

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NDA 206321 describes SAXENDA, which is a drug marketed by Novo and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the SAXENDA profile page.

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

Summary for 206321

Tradename:	SAXENDA
Applicant:	Novo
Ingredient:	liraglutide
Patents:	2

Pharmacology for NDA: 206321

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

Suppliers and Packaging for NDA: 206321

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321	NDA	Novo Nordisk	0169-2800	0169-2800-15	5 SYRINGE, PLASTIC in 1 CARTON (0169-2800-15) / 3 mL in 1 SYRINGE, PLASTIC
SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321	NDA	Novo Nordisk	0169-2800	0169-2800-90	1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-90) / 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:	Dec 23, 2014	TE:	AP2	RLD:	Yes
Patent:	8,114,833*PED	Patent Expiration:	Feb 13, 2026	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	9,968,659*PED	Patent Expiration:	Jul 9, 2037	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 206321

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	10,357,616	⤷ Get Started Free
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	6,458,924	⤷ Get Started Free
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	7,235,627	⤷ Get Started Free
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	11,446,443	⤷ Get Started Free
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	10,376,652	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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