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 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 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 | 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
International Patents for liraglutide recombinant
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | E483487 | ⤷ Try a Trial | |
| Australia | 2006207744 | An automatic injection device with a top release mechanism | ⤷ Try a Trial |
| Portugal | 3300721 | ⤷ Try a Trial | |
| Germany | 602005016952 | ⤷ Try a Trial | |
| European Patent Office | 1804865 | MECANISME A DISQUE SE DEPLACANT VERS LE BAS POUR DES SERINGUES AUTOMATIQUES (DIAL-DOWN MECHANISM FOR WIND-UP PEN) | ⤷ Try a Trial |
| Mexico | 2018010097 | LIRAGLUTIDA EN AFECCIONES CARDIOVASCULARES. (LIRAGLUTIDE IN CARDIOVASCULAR CONDITIONS.) | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2005049061 | ⤷ 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 |
| 2209800 | 1490067-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918 |
| 2209800 | 122014000114 | Germany | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918 |
| 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 |
| 0944648 | 09C0054 | France | ⤷ Try a Trial | 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 |
| 2209800 | C300698 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918 |
| 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 |
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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