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 nineteen 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. Three 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:	19

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 206321

Generic Entry Date for 206321^: ⤷ 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: 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:		RLD:	Yes
Patent:	10,220,155*PED	Patent Expiration:	Jan 17, 2027	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	10,357,616	Patent Expiration:	Jan 20, 2026	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	10,376,652	Patent Expiration:	Jan 20, 2026	Product Flag?	Y	Substance Flag?		Delist Request?

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	6,458,924	⤷ Subscribe
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	7,235,627	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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