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Last Updated: December 15, 2019

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Liraglutide recombinant - Generic Drug Details

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What are the generic sources for liraglutide recombinant and what is the scope of freedom to operate?

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

Liraglutide recombinant has three hundred and fifty-nine patent family members in thirty-one countries.

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

Summary for liraglutide recombinant

International Patents:	359
US Patents:	26
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	7
Suppliers / Packagers:	2
Bulk Api Vendors:	2
Clinical Trials:	359
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for liraglutide recombinant
DailyMed Link:	liraglutide recombinant at DailyMed

Recent Clinical Trials for liraglutide recombinant

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Sponsor	Phase
Steno Diabetes Center Copenhagen	Phase 4
Central Hospital, Nancy, France	Phase 4
RWTH Aachen University	Phase 3

See all liraglutide recombinant clinical trials

Recent Litigation for liraglutide recombinant

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District Court Litigation

Case Name	Date
Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.	2017-03-03
SMITH v. NOVO NORDISK INC.	2016-08-08
Novo Nordisk A/S v. Sanofi-Aventis	2005-09-02

See all liraglutide recombinant litigation

Pharmacology for liraglutide recombinant

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

Medical Subject Heading (MeSH) Categories for liraglutide recombinant

Hypoglycemic Agents
Incretins

Paragraph IV (Patent) Challenges for LIRAGLUTIDE RECOMBINANT

Tradename	Dosage	Ingredient	NDA	Submissiondate
VICTOZA	SOLUTION;SUBCUTANEOUS	liraglutide recombinant	022341	2016-12-12

US Patents and Regulatory Information for liraglutide recombinant

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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 recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010		RX	Yes	Yes	Start Trial	Start Trial			Y	Start 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 recombinant

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	Start Trial	Start Trial
Novo	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	Start Trial	Start Trial
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	Start Trial	Start Trial
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	Start Trial	Start Trial
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for liraglutide recombinant

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Country	Patent Number	Estimated Expiration
South Korea	101243648	Start Trial
Australia	748277	Start Trial
World Intellectual Property Organization (WIPO)	2006076921	Start Trial
Australia	2005298946	Start Trial
China	1740198	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for liraglutide recombinant

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2597103	2017/015	Ireland	Start 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	14C0085	France	Start Trial	PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
0944648	CA 2009 00041	Denmark	Start Trial
2209800	122014000114	Germany	Start Trial	PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
2209800	1490067-4	Sweden	Start Trial	PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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 verifification 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.

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