Saxenda is a drug owned by Novo Nordisk Inc. It is protected by 48 US drug patents filed from 2015 to 2022. Out of these, 32 drug patents are active and 16 have expired. Saxenda's patents have been open to challenges since 25 January, 2014. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 09, 2037. Details of Saxenda's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US6268343 | Derivatives of GLP-1 analogs |
Aug, 2022
(2 years ago) |
Expired
|
| US6458924 | Derivatives of GLP-1 analogs |
Aug, 2017
(7 years ago) |
Expired
|
| US7235627 | Derivatives of GLP-1 analogs |
Aug, 2017
(7 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9968659 (Pediatric) | Liraglutide in cardiovascular conditions |
Jul, 2037
(12 years from now) | Active |
| US9968659 | Liraglutide in cardiovascular conditions |
Jan, 2037
(11 years from now) | Active |
|
US9132239 (Pediatric) | Dial-down mechanism for wind-up pen |
Aug, 2032
(7 years from now) | Active |
| US9132239 | Dial-down mechanism for wind-up pen |
Feb, 2032
(6 years from now) | Active |
|
US9457154 (Pediatric) | Injection device with an end of dose feedback mechanism |
Mar, 2028
(2 years from now) | Active |
| US9457154 | Injection device with an end of dose feedback mechanism |
Sep, 2027
(2 years from now) | Active |
|
US9687611 (Pediatric) | Injection device with torsion spring and rotatable display |
Aug, 2027
(2 years from now) | Active |
| US9687611 | Injection device with torsion spring and rotatable display |
Feb, 2027
(1 year, 9 months from now) | Active |
|
USRE46363 (Pediatric) | Dial-down mechanism for wind-up pen |
Feb, 2027
(1 year, 8 months from now) | Active |
|
US8920383 (Pediatric) | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jan, 2027
(1 year, 8 months from now) | Active |
|
US9775953 (Pediatric) | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jan, 2027
(1 year, 8 months from now) | Active |
|
US10220155 (Pediatric) | Syringe device with a dose limiting mechanism and an additional safety mechanism |
Jan, 2027
(1 year, 8 months from now) | Active |
| US7686786 | Dial-down mechanism for wind-up pen |
Aug, 2026
(1 year, 2 months from now) | Active |
| USRE46363 | Dial-down mechanism for wind-up pen |
Aug, 2026
(1 year, 2 months from now) | Active |
|
US9108002 (Pediatric) | Automatic injection device with a top release mechanism |
Jul, 2026
(1 year, 2 months from now) | Active |
|
US9616180 (Pediatric) | Automatic injection device with a top release mechanism |
Jul, 2026
(1 year, 2 months from now) | Active |
|
US9861757 (Pediatric) | Injection device with an end of dose feedback mechanism |
Jul, 2026
(1 year, 2 months from now) | Active |
| US9775953 | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jul, 2026
(1 year, 2 months from now) | Active |
| US8920383 | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jul, 2026
(1 year, 2 months from now) | Active |
| US10220155 | Syringe device with a dose limiting mechanism and an additional safety mechanism |
Jul, 2026
(1 year, 2 months from now) | Active |
| US11097063 | Syringe device with a dose limiting mechanism and an additional safety mechanism |
Jul, 2026
(1 year, 2 months from now) | Active |
|
US8684969 (Pediatric) | Injection device with torsion spring and rotatable display |
Apr, 2026
(11 months from now) | Active |
|
US8114833 (Pediatric) | Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices |
Feb, 2026
(9 months from now) | Active |
| US9108002 | Automatic injection device with a top release mechanism |
Jan, 2026
(8 months from now) | Active |
| US10376652 | Automatic injection device with a top release mechanism |
Jan, 2026
(8 months from now) | Active |
| US9861757 | Injection device with an end of dose feedback mechanism |
Jan, 2026
(8 months from now) | Active |
| US9616180 | Automatic injection device with a top release mechanism |
Jan, 2026
(8 months from now) | Active |
| US11311679 | Automatic injection device with a top release mechanism |
Jan, 2026
(8 months from now) | Active |
| US10357616 | Injection device with an end of dose feedback mechanism |
Jan, 2026
(8 months from now) | Active |
| US8684969 | Injection device with torsion spring and rotatable display |
Oct, 2025
(5 months from now) | Active |
| US11446443 | Injection device with torsion spring and rotatable display |
Oct, 2025
(5 months from now) | Active |
| US8114833 | Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices |
Aug, 2025
(3 months from now) | Active |
|
US7762994 (Pediatric) | Needle mounting system and a method for mounting a needle assembly |
Nov, 2024
(5 months ago) |
Expired
|
| US7762994 | Needle mounting system and a method for mounting a needle assembly |
May, 2024
(11 months ago) |
Expired
|
|
US8579869 (Pediatric) | Needle mounting system and a method for mounting a needle assembly |
Dec, 2023
(1 year, 4 months ago) |
Expired
|
| US8579869 | Needle mounting system and a method for mounting a needle assembly |
Jun, 2023
(1 year, 10 months ago) |
Expired
|
|
US6268343 (Pediatric) | Derivatives of GLP-1 analogs |
Feb, 2023
(2 years ago) |
Expired
|
|
US8846618 (Pediatric) | Stable formulation of modified GLP-1 |
Dec, 2022
(2 years ago) |
Expired
|
|
US8672898 (Pediatric) | Automatic injection device with reset feature |
Jul, 2022
(2 years ago) |
Expired
|
|
US9486588 (Pediatric) | Automatic injection device with reset feature |
Jul, 2022
(2 years ago) |
Expired
|
|
US6899699 (Pediatric) | Automatic injection device with reset feature |
Jul, 2022
(2 years ago) |
Expired
|
| US8846618 | Stable formulation of modified GLP-1 |
Jun, 2022
(2 years ago) |
Expired
|
| US9486588 | Automatic injection device with reset feature |
Jan, 2022
(3 years ago) |
Expired
|
| US8672898 | Automatic injection device with reset feature |
Jan, 2022
(3 years ago) |
Expired
|
| US6899699 | Automatic injection device with reset feature |
Jan, 2022
(3 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Saxenda's patents.
Latest Legal Activities on Saxenda's Patents
Given below is the list of recent legal activities going on the following patents of Saxenda.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Feb, 2022 | US8846618 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Oct, 2021 | US9968659 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Oct, 2018 | US7235627 |
| Patent Issue Date Used in PTA Calculation Critical | 15 May, 2018 | US9968659 |
| Recordation of Patent Grant Mailed Critical | 15 May, 2018 | US9968659 |
| Email Notification Critical | 26 Apr, 2018 | US9968659 |
| Issue Notification Mailed Critical | 25 Apr, 2018 | US9968659 |
| Filing Receipt - Updated | 13 Apr, 2018 | US9968659 |
| Dispatch to FDC | 13 Apr, 2018 | US9968659 |
| Email Notification Critical | 13 Apr, 2018 | US9968659 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Saxenda and ongoing litigations to help you estimate the early arrival of Saxenda generic.
Saxenda's Litigations
Saxenda been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jul 22, 2020, against patent number US8114833. The petitioner Pfizer Inc., challenged the validity of this patent, with Novo Nordisk A/S as the respondent. Click below to track the latest information on how companies are challenging Saxenda's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8114833 | March, 2022 |
Terminated-Settled
(08 Sep, 2022) | Novo Nordisk A/S | Fresenius Kabi USA, LLC |
| US8114833 | December, 2019 |
Terminated-Settled
(21 Jun, 2021) | Novo Nordisk A/S et al. | Pfizer Inc. et al. |
| US8114833 | July, 2020 |
Terminated-Settled
(21 Jun, 2021) | Novo Nordisk A/S | Pfizer Inc. |
FDA has granted some exclusivities to Saxenda. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Saxenda, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Saxenda.
Exclusivity Information
Saxenda holds 3 exclusivities. All of its exclusivities have expired in 2023. Details of Saxenda's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 25, 2015 |
| New Product(NP) | Jan 25, 2017 |
| New Patient Population(NPP) | Dec 04, 2023 |
Several oppositions have been filed on Saxenda's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Saxenda's generic, the next section provides detailed information on ongoing and past EP oppositions related to Saxenda patents.
Saxenda's Oppositions Filed in EPO
Saxenda has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 23, 2006, by Owen Mumford Limited. This opposition was filed on patent number EP02726984A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP02726984A | NA | Genentech, Inc. | Patent maintained as amended |
| EP17710160A | May, 2022 | Dr. Schön, Neymeyr & Partner Patentanwälte mbB | Granted and Under Opposition |
| EP17710160A | May, 2022 | STADA Arzneimittel AG | Granted and Under Opposition |
| EP17710160A | May, 2022 | SANDOZ AG | Granted and Under Opposition |
| EP17710160A | May, 2022 | Adalvo Ltd. | Granted and Under Opposition |
| EP17710160A | Apr, 2022 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Hoffmann Eitle | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Dr. Reddy's Laboratories Limited | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Galenicum Health S.L.U. | Granted and Under Opposition |
| EP17196501A | Dec, 2019 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP04797453A | Aug, 2018 | Uexküll & Stolberg Partnerschaft von Patent- und Rechtsanwälten mbB | Opposition rejected |
| EP04797453A | Aug, 2018 | Generics (U.K.) Limited | Opposition rejected |
| EP04797453A | Aug, 2018 | Wittkopp, Alexander | Opposition rejected |
| EP04797453A | Aug, 2018 | Teva Pharmaceutical Industries Ltd | Opposition rejected |
| EP04797453A | Aug, 2018 | Sandoz AG | Opposition rejected |
| EP04797453A | Aug, 2018 | Fresenius Kabi Deutschland GmbH | Opposition rejected |
| EP06701034A | Jan, 2018 | Schwöbel, Thilo | Opposition rejected |
| EP06754730A | Dec, 2011 | Ypsomed AG | Patent maintained as amended |
| EP06754730A | Nov, 2011 | WMC Matthes Consulting | Patent maintained as amended |
| EP06762643A | Jul, 2010 | Sanofi-Aventis Deutschland GmbH | Patent maintained as amended |
| EP05796880A | Jul, 2010 | Ypsomed AG | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Stöckeler, Ferdinand | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | OWEN MUMFORD LIMITED | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Ferring International Center S.A. | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | COPERNICUS sp. zo.o. | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Genentech, Inc. | Granted and Under Opposition |
| EP06121820A | May, 2010 | SANOFI-AVENTIS DEUTSCHLAND GMBH | Opposition rejected |
| EP02745182A | Sep, 2008 | AMYLIN PHARMACEUTICALS, INC. | Opposition rejected |
| EP02726984A | Mar, 2006 | TecPharma Licensing AG | Patent maintained as amended |
| EP02726984A | Feb, 2006 | OWEN MUMFORD LIMITED | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Saxenda is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Saxenda's family patents as well as insights into ongoing legal events on those patents.
Saxenda's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Saxenda's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 09, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Saxenda Generic API suppliers:
Liraglutide is the generic name for the brand Saxenda. 2 different companies have already filed for the generic of Saxenda, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Saxenda's generic
How can I launch a generic of Saxenda before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Saxenda's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Saxenda's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Saxenda -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 18 mg/3 mL prefilled syringe | 16 Aug, 2021 | 1 | 09 Jan, 2037 |
Alternative Brands for Saxenda
Saxenda which is used for managing type 2 diabetes, cardiovascular disease, and chronic weight management in obese individuals., has several other brand drugs in the same treatment category and using the same active ingredient (Liraglutide). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Liraglutide. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Novo |
| |
| Novo Nordisk Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Liraglutide, Saxenda's active ingredient. Check the complete list of approved generic manufacturers for Saxenda
About Saxenda
Saxenda is a drug owned by Novo Nordisk Inc. It is used for managing type 2 diabetes, cardiovascular disease, and chronic weight management in obese individuals. Saxenda uses Liraglutide as an active ingredient. Saxenda was launched by Novo in 2014.
Approval Date:
Saxenda was approved by FDA for market use on 23 December, 2014.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Saxenda is 23 December, 2014, its NCE-1 date is estimated to be 25 January, 2014.
Active Ingredient:
Saxenda uses Liraglutide as the active ingredient. Check out other Drugs and Companies using Liraglutide ingredient
Treatment:
Saxenda is used for managing type 2 diabetes, cardiovascular disease, and chronic weight management in obese individuals.
Dosage:
Saxenda is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 18MG/3ML (6MG/ML) | SOLUTION | Prescription | SUBCUTANEOUS |