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 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 | |||
| 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 | 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 | SAXENDA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | ⤷ 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 |
|---|---|---|---|
| European Patent Office | 1819382 | DISPOSITIF D'INJECTION A RESSORT DE TORSION ET AFFICHAGE ROTATIF (INJECTION DEVICE WITH TORSION SPRING AND ROTATABLE DISPLAY) | ⤷ Try a Trial |
| European Patent Office | 3300721 | FORMULATIONS DE PEPTIDES CONTENANT DU PROPYLÈNE GLYCOL QUI SONT OPTIMALES POUR LA PRODUCTION ET DESTINÉES À ÊTRE UTILISÉES DANS DES DISPOSITIFS D'INJECTION (PROPYLENE GLYCOL-CONTAINING PEPTIDE FORMULATIONS WHICH ARE OPTIMAL FOR PRODUCTION AND FOR USE IN INJECTION DEVICES) | ⤷ Try a Trial |
| Germany | 602006010396 | ⤷ 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 | 14C0085 | France | ⤷ Try a Trial | PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918 |
| 0944648 | SPC/GB09/058 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630 |
| 2209800 | C300698 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918 |
| >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.
ISSN: 2162-2639
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