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Generated: October 19, 2017
What are the generic sources for liraglutide recombinant and what is the scope of liraglutide recombinant freedom to operate?
Liraglutide recombinant is the generic ingredient in two branded drugs marketed by Novo Nordisk Inc and is included in two NDAs. There are nineteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| US Patents: | 19 |
| Tradenames: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: see list | 6 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 1 |
| Clinical Trials: see list | 1,806 |
| Patent Applications: see list | 1 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | liraglutide recombinant at DailyMed |
| Ingredient-type | Glucagon-Like Peptide 1 |
| Drug Class | GLP-1 Receptor Agonist |
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novo Nordisk Inc | SAXENDA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | ► Subscribe | ► Subscribe | ||||||||
Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | ► Subscribe | ► Subscribe | ||||||||
Novo Nordisk Inc | VICTOZA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 022341-001 | Jan 25, 2010 | ► Subscribe | ► Subscribe | ||||||||
Novo Nordisk Inc | SAXENDA | liraglutide recombinant | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | ► Subscribe | ► Subscribe | ||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,616,180 | Automatic injection device with a top release mechanism | ► Subscribe | |||||||||||||
| 6,384,016 | Stabilized aqueous peptide solutions | ► Subscribe | |||||||||||||
| 7,686,786 | Dial-down mechanism for wind-up pen | ► Subscribe | |||||||||||||
| 6,582,404 | Dose setting limiter | ► Subscribe | |||||||||||||
| 8,097,698 | Derivatives of GLP-1 analogs | ► Subscribe | |||||||||||||
| 8,096,978 | Automatic injection device with a top release mechanism | ► Subscribe | |||||||||||||
| 7,226,990 | Extendin derivatives | ► Subscribe | |||||||||||||
| 6,235,004 | Injection syringe | ► Subscribe | |||||||||||||
| 8,357,120 | Injection device with torsion spring and rotatable display | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2008528144 | ► Subscribe | |||||||||||||
| Australia | 2006208606 | ► Subscribe | |||||||||||||
| Hungary | 222513 | ► Subscribe | |||||||||||||
| Russian Federation | 2214286 | ► Subscribe | |||||||||||||
| China | 102196835 | ► Subscribe | |||||||||||||
| Hungary | 0003920 | ► Subscribe | |||||||||||||
| Japan | 5562510 | ► Subscribe | |||||||||||||
| Denmark | 1351732 | ► Subscribe | |||||||||||||
| South Korea | 20060100428 | ► Subscribe | |||||||||||||
| China | 101084028 | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB09/058 | United Kingdom | ► Subscribe | PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630 | ||||||||||||
| 2209800/01 | Switzerland | ► Subscribe | PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014 | ||||||||||||
| 0944648/01 | Switzerland | ► Subscribe | PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009 | ||||||||||||
| C0054 | France | ► Subscribe | 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 | ||||||||||||
| C034/2009 | Ireland | ► Subscribe | SPC034/2009: 20101001, EXPIRES: 20220821 | ||||||||||||
| 2014000114 | Germany | ► Subscribe | PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918 | ||||||||||||
| 00698 | Netherlands | ► Subscribe | PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918 | ||||||||||||
| 90067-4 | Sweden | ► Subscribe | PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918 | ||||||||||||
| C0085 | France | ► Subscribe | PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918 | ||||||||||||
| 2009 00041 | Denmark | ► Subscribe | |||||||||||||
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