Liraglutide - Generic Drug Details
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What are the generic drug sources for liraglutide and what is the scope of patent protection?
Liraglutide
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 has two hundred and three patent family members in twenty-nine countries.
There are seven drug master file entries for liraglutide. Three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for liraglutide
International Patents: | 203 |
US Patents: | 20 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 3 |
Clinical Trials: | 424 |
Patent Applications: | 7,047 |
Drug Prices: | Drug price trends for liraglutide |
What excipients (inactive ingredients) are in liraglutide? | liraglutide excipients list |
DailyMed Link: | liraglutide at DailyMed |
Recent Clinical Trials for liraglutide
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Chicago | Early Phase 1 |
Mỹ Đức Hospital | Phase 3 |
Columbia University | Phase 4 |
Generic filers with tentative approvals for LIRAGLUTIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 18MG/3ML(6MG/ML) | INJECTABLE;INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for liraglutide
Drug Class | GLP-1 Receptor Agonist |
Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for liraglutide
Paragraph IV (Patent) Challenges for LIRAGLUTIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SAXENDA | Injection | liraglutide | 18 mg/3 mL prefilled syringe | 206321 | 1 | 2021-08-16 |
VICTOZA | Injection | liraglutide | 18 mg/3 mL prefilled syringe | 022341 | 1 | 2016-12-12 |
US Patents and Regulatory Information for liraglutide
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 | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novo Nordisk Inc | VICTOZA | liraglutide | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Novo Nordisk Inc | VICTOZA | liraglutide | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for liraglutide
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 200703706 | Injection device with torsion spring and rotatable display | ⤷ Sign Up |
Russian Federation | 2005102605 | СИСТЕМА ДЛЯ УСТАНОВКИ ИГЛЫ И СПОСОБ КРЕПЛЕНИЯ УЗЛА С ИГЛОЙ | ⤷ Sign Up |
Australia | 2008213084 | Injection button | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for liraglutide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2209800 | 132014902311502 | Italy | ⤷ Sign Up | PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918 |
2209800 | 122014000114 | Germany | ⤷ Sign Up | PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918 |
2209800 | SPC/GB14/079 | United Kingdom | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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