SAXENDA Drug Patent Profile
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Which patents cover Saxenda, and what generic alternatives are available?
Saxenda is a drug marketed by Novo and is included in one NDA. There are nineteen patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and eighty-eight patent family members in twenty-nine countries.
The generic ingredient in SAXENDA is liraglutide. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the liraglutide profile page.
DrugPatentWatch® Generic Entry Outlook for Saxenda
Saxenda was eligible for patent challenges on January 25, 2014.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 13, 2026. This may change due to patent challenges or generic licensing.
Annual sales in 2021 were $439mm indicating the motivation for generic entry.
There have been twenty-one patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (liraglutide), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for SAXENDA?
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Summary for SAXENDA
International Patents: | 188 |
US Patents: | 19 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 27 |
Clinical Trials: | 33 |
Patent Applications: | 2,996 |
Drug Prices: | Drug price information for SAXENDA |
Drug Sales Revenues: | Drug sales revenues for SAXENDA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SAXENDA |
What excipients (inactive ingredients) are in SAXENDA? | SAXENDA excipients list |
DailyMed Link: | SAXENDA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SAXENDA
Generic Entry Date for SAXENDA*:
Constraining patent/regulatory exclusivity:
NDA:
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 SAXENDA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Chicago | Early Phase 1 |
Sciwind Biosciences APAC CO Pty. Ltd. | Phase 2 |
Hangzhou Sciwind Biosciences Co., Ltd. | Phase 2 |
Pharmacology for SAXENDA
Drug Class | GLP-1 Receptor Agonist |
Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Paragraph IV (Patent) Challenges for SAXENDA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SAXENDA | Injection | liraglutide | 18 mg/3 mL prefilled syringe | 206321 | 1 | 2021-08-16 |
US Patents and Regulatory Information for SAXENDA
SAXENDA is protected by nineteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of SAXENDA is ⤷ Subscribe.
This potential generic entry date is based on patent 8,114,833.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting SAXENDA
Syringe device with a dose limiting mechanism and an additional safety mechanism
Patent Number: 10,220,155*PED
Patent Expiration: ⤷ Subscribe
Injection device with an end of dose feedback mechanism
Patent Number: 10,357,616
Patent Expiration: ⤷ Subscribe
Automatic injection device with a top release mechanism
Patent Number: 10,376,652
Patent Expiration: ⤷ Subscribe
Syringe device with a dose limiting mechanism and an additional safety mechanism
Patent Number: 11,097,063
Patent Expiration: ⤷ Subscribe
Automatic injection device with a top release mechanism
Patent Number: 11,311,679
Patent Expiration: ⤷ Subscribe
Patent Number: 11,446,443
Patent Expiration: ⤷ Subscribe
Needle mounting system and a method for mounting a needle assembly
Patent Number: 7,762,994*PED
Patent Expiration: ⤷ Subscribe
Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Patent Number: 8,114,833*PED
Patent Expiration: ⤷ Subscribe
Injection device with torsion spring and rotatable display
Patent Number: 8,684,969*PED
Patent Expiration: ⤷ Subscribe
Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: 8,920,383*PED
Patent Expiration: ⤷ Subscribe
Automatic injection device with a top release mechanism
Patent Number: 9,108,002*PED
Patent Expiration: ⤷ Subscribe
Dial-down mechanism for wind-up pen
Patent Number: 9,132,239*PED
Patent Expiration: ⤷ Subscribe
Injection device with an end of dose feedback mechanism
Patent Number: 9,457,154*PED
Patent Expiration: ⤷ Subscribe
Automatic injection device with a top release mechanism
Patent Number: 9,616,180*PED
Patent Expiration: ⤷ Subscribe
Injection device with torsion spring and rotatable display
Patent Number: 9,687,611*PED
Patent Expiration: ⤷ Subscribe
Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: 9,775,953*PED
Patent Expiration: ⤷ Subscribe
Injection device with an end of dose feedback mechanism
Patent Number: 9,861,757*PED
Patent Expiration: ⤷ Subscribe
Liraglutide in cardiovascular conditions
Patent Number: 9,968,659*PED
Patent Expiration: ⤷ Subscribe
Dial-down mechanism for wind-up pen
Patent Number: RE46363*PED
Patent Expiration: ⤷ Subscribe
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 | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | 11,097,063 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | 7,762,994*PED | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | RE46363*PED | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | 10,376,652 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
>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 SAXENDA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | 6,458,924 | ⤷ Subscribe |
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | 7,235,627 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SAXENDA
See the table below for patents covering SAXENDA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1909870 | MECANISME DE DOSAGE POUR UN DISPOSITIF D'INJECTION PERMETTANT DE LIMITER UN DOSAGE CORRESPONDANT A LA QUANTITE DE MEDICAMENT RESTANTE (DOSE MECHANISM FOR AN INJECTION DEVICE FOR LIMITING A DOSE SETTING CORRESPONDING TO THE AMOUNT OF MEDICAMENT LEFT) | ⤷ Subscribe |
Russian Federation | 2401133 | АВТОМАТИЧЕСКОЕ ИНЪЕКЦИОННОЕ УСТРОЙСТВО С ВЕРХНИМ РАЗБЛОКИРУЮЩИМ МЕХАНИЗМОМ (AUTOMATIC INJECTION DEVICE WITH UPPER UNLOCK MECHANISM) | ⤷ Subscribe |
Japan | 4970282 | ⤷ Subscribe | |
South Korea | 20070084393 | DIAL-DOWN MECHANISM FOR WIND-UP PEN | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SAXENDA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2209800 | SPC/GB14/079 | United Kingdom | ⤷ Subscribe | 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 | 14C0085 | France | ⤷ Subscribe | PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918 |
0944648 | CA 2009 00041 | Denmark | ⤷ Subscribe | |
2597103 | 2017/015 | Ireland | ⤷ Subscribe | PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; NAT REGISTRATION NO/DATE: EU/1/14/947 20140918; FIRST REGISTRATION NO/DATE: 65041 20140912 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |