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SAXENDA Drug Patent Profile

Which patents cover Saxenda, 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. 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.

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-one 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.

There is one tentative approval for the generic drug (liraglutide), which indicates the potential for near-term generic launch.

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:	33
Patent Applications:	2,996
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
University of Chicago	Early Phase 1
Hangzhou Sciwind Biosciences Co., Ltd.	Phase 2
Sciwind Biosciences APAC CO Pty. Ltd.	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

Paragraph IV (Patent) Challenges for SAXENDA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SAXENDA	Injection	liraglutide	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	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes			Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes					Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes					Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes			Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes					Y
Novo	SAXENDA	liraglutide	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	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014
Novo	SAXENDA	liraglutide	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
European Patent Office	3423082	LIRAGLUTIDE UTILISÉ DANS LE TRAITEMENT DE MALADIES CARDIOVASCULAIRES (LIRAGLUTIDE IN CARDIOVASCULAR CONDITIONS)
Japan	2002512175
Canada	2584762	DISPOSITIF D'INJECTION A RESSORT DE TORSION ET AFFICHAGE ROTATIF (INJECTION DEVICE WITH TORSION SPRING AND ROTATABLE DISPLAY)
Canada	2264243	DERIVES DE GLP-1 (GLP-1 DERIVATIVES)
Japan	2008528144
China	1509193

Supplementary Protection Certificates for SAXENDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2209800	1490067-4	Sweden		PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
0944648	CA 2009 00041	Denmark
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
2209800	132014902311502	Italy		PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918
0944648	C00944648/01	Switzerland		PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009
0944648	09C0054	France		PRODUCT NAME: LIRAGLUTIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/529/001 DU 20090630; REGISTRATION NO/DATE AT EEC: EU/1/09/529/001 DU 20090630