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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.
Summary for liraglutide recombinant
International Patents: | 359 |
US Patents: | 26 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 7 |
Suppliers / Packagers: | 2 |
Bulk Api Vendors: | 2 |
Clinical Trials: | 359 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for liraglutide recombinant |
DailyMed Link: | liraglutide recombinant at DailyMed |
Recent Clinical Trials for liraglutide recombinant
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Steno Diabetes Center Copenhagen | Phase 4 |
Central Hospital, Nancy, France | Phase 4 |
RWTH Aachen University | Phase 3 |
Recent Litigation for liraglutide recombinant
Identify potential future generic entrants
District Court Litigation
Case Name | Date |
---|---|
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-Aventis | 2005-09-02 |
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 | 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 |
International Patents for liraglutide recombinant
Country | Patent Number | Estimated Expiration |
---|---|---|
South Korea | 101243648 | Start Trial |
Australia | 748277 | Start Trial |
World Intellectual Property Organization (WIPO) | 2006076921 | Start Trial |
Australia | 2005298946 | Start Trial |
China | 1740198 | Start Trial |
>Country | >Patent Number | >Estimated 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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