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SAXENDA Drug Patent Profile

When do Saxenda patents expire, and what generic alternatives are available?

Saxenda is a drug marketed by Novo and is included in one NDA. There are nineteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-eight patent family members in twenty-nine countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Saxenda

Saxenda was eligible for patent challenges on January 25, 2014.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 13, 2026. This may change due to patent challenges or generic licensing.

Annual sales in 2021 were $439mm indicating the motivation for generic entry.

There have been twenty patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SAXENDA

International Patents:	188
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	32
Patent Applications:	3,742
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SAXENDA
Drug Sales Revenues:	Drug sales revenues for SAXENDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SAXENDA
What excipients (inactive ingredients) are in SAXENDA?	SAXENDA excipients list
DailyMed Link:	SAXENDA at DailyMed

See drug prices for SAXENDA

See drug sales revenues for SAXENDA

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

NDA:

206321

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.

Recent Clinical Trials for SAXENDA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hangzhou Sciwind Biosciences Co., Ltd.	Phase 2
Sciwind Biosciences APAC CO Pty. Ltd.	Phase 2
National Institute on Drug Abuse (NIDA)	Phase 1/Phase 2

See all SAXENDA clinical trials

Pharmacology for SAXENDA

Drug Class	GLP-1 Receptor Agonist
Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

Anatomical Therapeutic Chemical (ATC) Classes for SAXENDA

A10BJ	Glucagon-like peptide-1 (GLP-1) analogues
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for SAXENDA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SAXENDA	Injection	liraglutide recombinant	18 mg/3 mL prefilled syringe	206321	1	2021-08-16

US Patents and Regulatory Information for SAXENDA

SAXENDA is protected by nineteen US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SAXENDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes			Y
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes					Y
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes					Y
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes			Y
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes					Y
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes					Y
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes					Y

Expired US Patents for SAXENDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014

International Patents for SAXENDA

See the table below for patents covering SAXENDA around the world.

Country	Patent Number	Title	Estimated Expiration
China	1271086
European Patent Office	1826216
World Intellectual Property Organization (WIPO)	2006045528
European Patent Office	1877119	DISPOSITIF D'INJECTION AVEC UN SIGNAL DE RETOUR D'UNE DOSE TERMINÉE (AN INJECTION DEVICE WITH AN END OF DOSE FEEDBACK MECHANISM)
Germany	602005016952
Australia	2002316811
World Intellectual Property Organization (WIPO)	9943341

Supplementary Protection Certificates for SAXENDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2597103	2017/015	Ireland		PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; NAT REGISTRATION NO/DATE: EU/1/14/947 20140918; FIRST REGISTRATION NO/DATE: 65041 20140912
0944648	SPC/GB09/058	United Kingdom		PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630
0944648	CA 2009 00041	Denmark
2209800	1490067-4	Sweden		PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2209800	14C0085	France		PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2209800	C300698	Netherlands		PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
2209800	SPC/GB14/079	United Kingdom		PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF, AND LIRAGLUTIDE, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF; REGISTERED: CH 65041 20140912; UK EU/1/14/947 20140922