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Last Updated: May 19, 2024

Liraglutide - Generic Drug Details

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What are the generic drug sources for liraglutide and what is the scope of patent protection?

Liraglutide is the generic ingredient in two branded drugs marketed by Novo and Novo Nordisk Inc, and is included in two NDAs. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Liraglutide has two hundred and three patent family members in twenty-nine countries.

There are seven drug master file entries for liraglutide. Two suppliers are listed for this compound.

Summary for liraglutide

International Patents:	203
US Patents:	20
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	2
Clinical Trials:	422
What excipients (inactive ingredients) are in liraglutide?	liraglutide excipients list
DailyMed Link:	liraglutide at DailyMed

Recent Clinical Trials for liraglutide

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

Sponsor	Phase
Columbia University	Phase 4
Dr Adnan Agha	Phase 1/Phase 2
Carmot Therapeutics, Inc.	Phase 1

See all liraglutide clinical trials

Pharmacology for liraglutide

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

Anatomical Therapeutic Chemical (ATC) Classes for liraglutide

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 LIRAGLUTIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SAXENDA	Injection	liraglutide	18 mg/3 mL prefilled syringe	206321	1	2021-08-16
VICTOZA	Injection	liraglutide	18 mg/3 mL prefilled syringe	022341	1	2016-12-12

US Patents and Regulatory Information for liraglutide

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for liraglutide

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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	⤷ Try a Trial	⤷ Try a Trial
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	⤷ Try a Trial	⤷ Try a Trial
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	⤷ Try a Trial	⤷ Try a Trial
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for liraglutide

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Country	Patent Number	Title	Estimated Expiration
Canada	2616248	APPAREIL A SERINGUE AVEC MECANISME DE LIMITATION DOSE ET DE MECANISME SUPPLEMENTAIRE DE SECURITE (SYRINGE DEVICE WITH A DOSE LIMITING MECHANISM AND AN ADDITIONAL SAFETY MECHANISM)	⤷ Try a Trial
South Africa	200703707	Dial-Down Mechanism for Wind-up Pen	⤷ Try a Trial
Poland	1687019		⤷ Try a Trial
Denmark	1877119		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for liraglutide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2597103	2017/015	Ireland	⤷ Try a Trial	PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; NAT REGISTRATION NO/DATE: EU/1/14/947 20140918; FIRST REGISTRATION NO/DATE: 65041 20140912
2209800	122014000114	Germany	⤷ Try a Trial	PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
2209800	1490067-4	Sweden	⤷ Try a Trial	PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
0944648	09C0054	France	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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