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Last Updated: March 8, 2021

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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.

Recent Clinical Trials for liraglutide recombinant

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

SponsorPhase
University of MinnesotaPhase 3
Huashan HospitalPhase 2/Phase 3
Xiaojun ChenPhase 2/Phase 3

See all liraglutide recombinant clinical trials

Pharmacology for liraglutide recombinant
Medical Subject Heading (MeSH) Categories for liraglutide recombinant
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

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

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

Supplementary Protection Certificates for liraglutide recombinant

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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Harvard Business School
McKinsey
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