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.
Summary for liraglutide recombinant
| International Patents: | 314 |
| US Patents: | 26 |
| Tradenames: | 2 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 413 |
| 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 |
|---|---|
| David Sanchez Garcia | Phase 3 |
| Instituto Mexicano del Seguro Social | Phase 3 |
| The First Affiliated Hospital with Nanjing Medical University | N/A |
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
Expired US Patents for liraglutide recombinant
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.
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