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 one supplier. There are twenty-five patents protecting this drug. Additional details are available on the SAXENDA profile page.

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

Summary for 206321

Tradename:	SAXENDA
Applicant:	Novo
Ingredient:	liraglutide recombinant
Patents:	25
Formulation / Manufacturing:	see details

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for 206321

Generic Entry Date for 206321^: See Plans and Pricing* Constraining patent/regulatory exclusivity: See Plans and Pricing 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

Medical Subject Heading (MeSH) Categories for 206321

Hypoglycemic Agents
Incretins

Suppliers and Packaging for NDA: 206321

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SAXENDA	liraglutide recombinant	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 recombinant	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
Regulatory Exclusivity Expiration:	Dec 4, 2023
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Patent:	See Plans and Pricing	Patent Expiration:	Jan 17, 2027	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	See Plans and Pricing	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 recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	See Plans and Pricing	See Plans and Pricing
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.