SAXENDA Drug Patent Profile
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When do Saxenda patents expire, 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. Two 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 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.
Indicators of Generic Entry
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: | 32 |
Patent Applications: | 3,742 |
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 |
---|---|
Sciwind Biosciences APAC CO Pty. Ltd. | Phase 2 |
Hangzhou Sciwind Biosciences Co., Ltd. | Phase 2 |
National Institutes of Health (NIH) | Phase 1/Phase 2 |
Pharmacology for SAXENDA
Drug Class | GLP-1 Receptor Agonist |
Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for SAXENDA
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Injection device with an end of dose feedback mechanism
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Automatic injection device with a top release mechanism
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Syringe device with a dose limiting mechanism and an additional safety mechanism
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Automatic injection device with a top release mechanism
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Needle mounting system and a method for mounting a needle assembly
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Injection device with torsion spring and rotatable display
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Automatic injection device with a top release mechanism
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dial-down mechanism for wind-up pen
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Injection device with an end of dose feedback mechanism
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Automatic injection device with a top release mechanism
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Injection device with torsion spring and rotatable display
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Injection device with an end of dose feedback mechanism
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Liraglutide in cardiovascular conditions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dial-down mechanism for wind-up pen
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novo | SAXENDA | liraglutide | 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 SAXENDA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novo | SAXENDA | liraglutide | SOLUTION;SUBCUTANEOUS | 206321-001 | Dec 23, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Novo | SAXENDA | liraglutide | 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 SAXENDA
See the table below for patents covering SAXENDA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2616248 | APPAREIL A SERINGUE AVEC MECANISME DE LIMITATION DOSE ET DE MECANISME SUPPLEMENTAIRE DE SECURITE (SYRINGE DEVICE WITH A DOSE LIMITING MECHANISM AND AN ADDITIONAL SAFETY MECHANISM) | ⤷ Try a Trial |
Canada | 2584760 | MECANISME A DISQUE SE DEPLACANT VERS LE BAS POUR DES SERINGUES AUTOMATIQUES (DIAL-DOWN MECHANISM FOR WIND-UP PEN) | ⤷ Try a Trial |
European Patent Office | 1840134 | Dérivés du GLP-1 (GLP-1 derivatives) | ⤷ Try a Trial |
Denmark | 1877119 | ⤷ Try a Trial | |
Japan | 2002504527 | ⤷ Try a Trial | |
Portugal | 944648 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2006079481 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SAXENDA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2209800 | 1490067-4 | Sweden | ⤷ Try a Trial | PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918 |
2209800 | C300698 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918 |
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 |
2209800 | 132014902311502 | Italy | ⤷ Try a Trial | PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918 |
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 |
0944648 | SPC034/2009 | Ireland | ⤷ Try a Trial | SPC034/2009: 20101001, EXPIRES: 20220821 |
0944648 | C00944648/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |