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 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.
Summary for LIRAGLUTIDE RECOMBINANT
International Patents: | 203 |
US Patents: | 20 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 27 |
Clinical Trials: | 422 |
Patent Applications: | 7,246 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LIRAGLUTIDE RECOMBINANT |
DailyMed Link: | LIRAGLUTIDE RECOMBINANT at DailyMed |
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
Sponsor | Phase |
---|---|
Columbia University | Phase 4 |
Dr Adnan Agha | Phase 1/Phase 2 |
Carmot Therapeutics, Inc. | Phase 1 |
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
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 | 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 | 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 | |||
>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 |
Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | ⤷ 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 |
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 |
---|---|---|---|
Russian Federation | 2462275 | НАЖИМНАЯ КНОПКА ДЛЯ ИНЪЕКЦИОННОГО УСТРОЙСТВА (PUSHBUTTON FOR INJECTION DEVICE) | ⤷ Try a Trial |
Portugal | 1536854 | ⤷ Try a Trial | |
Mexico | PA06005581 | FORMULACIONES DE PEPTIDOS QUE CONTIENEN PROPILENGLICOL QUE SON OPTIMAS PARA LA PRODUCCION Y USO EN DISPOSITIVOS DE INYECCION. (PROPYLENE GLYCOL-CONTAINING PEPTIDE FORMULATIONS WHICH ARE OPTIMAL FOR PRODUCTION AND FOR USE IN INJECTION DEVICES.) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2006045528 | ⤷ Try a Trial | |
Russian Federation | 2506957 | МЕХАНИЗМ УМЕНЬШЕНИЯ УСТАНОВЛЕННОЙ ДОЗЫ ДЛЯ ВЗВОДИМОГО ШПРИЦА-РУЧКИ (MECHANISM OF REDUCING ESTABLISHED DOSE FOR COCKED PREFILLED SYRINGE) | ⤷ Try a Trial |
European Patent Office | 1877119 | DISPOSITIF D'INJECTION AVEC UN SIGNAL DE RETOUR D'UNE DOSE TERMINÉE (AN INJECTION DEVICE WITH AN END OF DOSE FEEDBACK 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 | C300698 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918 |
0944648 | SPC/GB09/058 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630 |
2597103 | 2017/015 | Ireland | ⤷ Try a 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 | 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 |
2209800 | 122014000114 | Germany | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918 |
2209800 | 132014902311502 | Italy | ⤷ Try a Trial | 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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