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Last Updated: December 5, 2022

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-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 fourteen patent family members in thirty-two countries.

Two suppliers are listed for this compound.

Recent Clinical Trials for liraglutide recombinant

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

SponsorPhase
David Sanchez GarciaPhase 3
Instituto Mexicano del Seguro SocialPhase 3
The First Affiliated Hospital with Nanjing Medical UniversityN/A

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 Strength NDA ANDAs Submitted Submissiondate
SAXENDA Injection liraglutide recombinant 18 mg/3 mL prefilled syringe 206321 1 2021-08-16
VICTOZA Injection liraglutide recombinant 18 mg/3 mL prefilled syringe 022341 1 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 See Plans and Pricing See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 See Plans and Pricing See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 See Plans and Pricing See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 See Plans and Pricing See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 See Plans and Pricing See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for liraglutide recombinant

Country Patent Number Title Estimated Expiration
European Patent Office 1843809 DISPOSITIF D'INJECTION AUTOMATIQUE MUNI D'UN MECANISME DE LIBERATION SUPERIEUR (AN AUTOMATIC INJECTION DEVICE WITH A TOP RELEASE MECHANISM) See Plans and Pricing
Israel 261169 ליראגלוטיד במצבים של הלב וכלי הדם (Liraglutide in cardiovascular conditions) See Plans and Pricing
Austria 439883 See Plans and Pricing
Hungary 9903714 See Plans and Pricing
Austria 382057 See Plans and Pricing
Slovenia 1687019 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for liraglutide recombinant

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2597103 2017/015 Ireland See Plans and Pricing PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; NAT REGISTRATION NO/DATE: EU/1/14/947 20140918; FIRST REGISTRATION NO/DATE: 65041 20140912
2209800 SPC/GB14/079 United Kingdom See Plans and Pricing PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF, AND LIRAGLUTIDE, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF; REGISTERED: CH 65041 20140912; UK EU/1/14/947 20140922
2209800 C300698 Netherlands See Plans and Pricing PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
0944648 09C0054 France See Plans and Pricing PRODUCT NAME: LIRAGLUTIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/529/001 DU 20090630; REGISTRATION NO/DATE AT EEC: EU/1/09/529/001 DU 20090630
0944648 SPC034/2009 Ireland See Plans and Pricing SPC034/2009: 20101001, EXPIRES: 20220821
2209800 132014902311502 Italy See Plans and Pricing 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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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 verification 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.