Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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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.

Recent Clinical Trials for liraglutide recombinant

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

SponsorPhase
Steno Diabetes Center CopenhagenPhase 4
Central Hospital, Nancy, FrancePhase 4
RWTH Aachen UniversityPhase 3

See all liraglutide recombinant clinical trials

Recent Litigation for liraglutide recombinant

Identify potential future generic entrants

District Court Litigation
Case NameDate
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-Aventis2005-09-02

See all liraglutide recombinant litigation

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 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

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

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 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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Serving leading biopharmaceutical companies globally:

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Dow
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Express Scripts

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