You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Liraglutide recombinant - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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 patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Liraglutide recombinant has two hundred and three patent family members in twenty-nine countries.

Two suppliers are listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for liraglutide recombinant
Generic Entry Dates for liraglutide recombinant*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS
Generic Entry Dates for liraglutide recombinant*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for liraglutide recombinant

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

SponsorPhase
Columbia UniversityPhase 4
Dr Adnan AghaPhase 1/Phase 2
Carmot Therapeutics, Inc.Phase 1

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

International Patents for liraglutide recombinant

Country Patent Number Title Estimated Expiration
Philippines 12018501844 LIRAGLUTIDE IN CARDIOVASCULAR CONDITIONS ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006045526 ⤷  Try a Trial
Russian Federation 2401133 АВТОМАТИЧЕСКОЕ ИНЪЕКЦИОННОЕ УСТРОЙСТВО С ВЕРХНИМ РАЗБЛОКИРУЮЩИМ МЕХАНИЗМОМ (AUTOMATIC INJECTION DEVICE WITH UPPER UNLOCK MECHANISM) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for liraglutide recombinant

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2209800 132014902311502 Italy ⤷  Try a Trial PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918
2209800 SPC/GB14/079 United Kingdom ⤷  Try a Trial 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
0944648 09C0054 France ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.