Liraglutide recombinant - Generic Drug Details

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What are the generic drug 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-four 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 thirty-five 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:	335
US Patents:	24
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	7
Suppliers / Packagers:	2
Bulk Api Vendors:	2
Clinical Trials:	382
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

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

Sponsor	Phase
University of Minnesota	Phase 3
Huashan Hospital	Phase 2/Phase 3
Xiaojun Chen	Phase 2/Phase 3

See all liraglutide recombinant clinical trials

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 Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010		RX	Yes	Yes	Start Trial	Start Trial				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	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	SAXENDA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		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 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
Denmark	1570876	Start Trial
Japan	5340603	Start Trial
Germany	20023819	Start Trial
European Patent Office	1877119	Start Trial
Poland	196742	Start Trial
Russian Federation	2388498	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	C300698	Netherlands	Start Trial	PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
0944648	C00944648/01	Switzerland	Start Trial	PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009
2209800	1490067-4	Sweden	Start Trial	PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2209800	132014902311502	Italy	Start Trial	PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918
2209800	14C0085	France	Start Trial	PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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