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
*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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Injection device with an end of dose feedback mechanism
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Automatic injection device with a top release mechanism
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Syringe device with a dose limiting mechanism and an additional safety mechanism
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Automatic injection device with a top release mechanism
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Needle mounting system and a method for mounting a needle assembly
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Injection device with torsion spring and rotatable display
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Automatic injection device with a top release mechanism
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dial-down mechanism for wind-up pen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Injection device with an end of dose feedback mechanism
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Automatic injection device with a top release mechanism
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Injection device with torsion spring and rotatable display
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Injection device with an end of dose feedback mechanism
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Liraglutide in cardiovascular conditions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dial-down mechanism for wind-up pen
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| Canada | 2584760 | MECANISME A DISQUE SE DEPLACANT VERS LE BAS POUR DES SERINGUES AUTOMATIQUES (DIAL-DOWN MECHANISM FOR WIND-UP PEN) | ⤷ Sign Up |
| Denmark | 1804865 | ⤷ Sign Up | |
| China | 113304250 | 对于生产和用于注射装置中是最佳的含有丙二醇的肽制剂 (Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SAXENDA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2209800 | 132014902311502 | Italy | ⤷ Sign Up | PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918 |
| 0944648 | CA 2009 00041 | Denmark | ⤷ Sign Up | |
| 2209800 | SPC/GB14/079 | United Kingdom | ⤷ Sign Up | 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 |
| >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.
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