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. Three suppliers are listed for this compound. There is one tentative approval 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:	3
Clinical Trials:	424
Patent Applications:	7,047
Drug Prices:	Drug price trends for liraglutide
What excipients (inactive ingredients) are in liraglutide?	liraglutide excipients list
DailyMed Link:	liraglutide at DailyMed

See drug prices for liraglutide

Recent Clinical Trials for liraglutide

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

Sponsor	Phase
University of Chicago	Early Phase 1
Mỹ Đức Hospital	Phase 3
Columbia University	Phase 4

See all liraglutide clinical trials

Generic filers with tentative approvals for LIRAGLUTIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	18MG/3ML(6MG/ML)	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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 Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	⤷ Sign Up	⤷ Sign Up
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	⤷ Sign Up	⤷ Sign Up
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	⤷ Sign Up	⤷ Sign Up
>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
Germany	602008002896		⤷ Sign Up
Denmark	1843809		⤷ Sign Up
Denmark	2373361		⤷ Sign Up
>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	⤷ Sign Up	PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; NAT REGISTRATION NO/DATE: EU/1/14/947 20140918; FIRST REGISTRATION NO/DATE: 65041 20140912
2209800	C300698	Netherlands	⤷ Sign Up	PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
2209800	132014902311502	Italy	⤷ Sign Up	PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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