Tresiba is a drug owned by Novo Nordisk Inc. It is protected by 20 US drug patents filed from 2015 to 2019. Out of these, 15 drug patents are active and 5 have expired. Tresiba's patents have been open to challenges since 26 September, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 01, 2032. Details of Tresiba'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. | |||
| US7615532 | Insulin derivatives |
Jun, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9132239 | Dial-down mechanism for wind-up pen |
Feb, 2032
(7 years from now) | Active |
| US9457154 | Injection device with an end of dose feedback mechanism |
Sep, 2027
(2 years from now) | Active |
| US9687611 | Injection device with torsion spring and rotatable display |
Feb, 2027
(2 years from now) | Active |
| US7686786 | Dial-down mechanism for wind-up pen |
Aug, 2026
(1 year, 8 months from now) | Active |
| USRE46363 | Dial-down mechanism for wind-up pen |
Aug, 2026
(1 year, 8 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, 7 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, 7 months from now) | Active |
| US10220155 | Syringe device with a dose limiting mechanism and an additional safety mechanism |
Jul, 2026
(1 year, 7 months from now) | Active |
| US10357616 | Injection device with an end of dose feedback mechanism |
Jan, 2026
(1 year, 2 months from now) | Active |
| US9616180 | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 2 months from now) | Active |
| US9108002 | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 2 months from now) | Active |
| US9861757 | Injection device with an end of dose feedback mechanism |
Jan, 2026
(1 year, 2 months from now) | Active |
| US10376652 | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 2 months from now) | Active |
| US8684969 | Injection device with torsion spring and rotatable display |
Oct, 2025
(11 months from now) | Active |
| US7762994 | Needle mounting system and a method for mounting a needle assembly |
May, 2024
(5 months ago) |
Expired
|
| US8579869 | Needle mounting system and a method for mounting a needle assembly |
Jun, 2023
(1 year, 4 months ago) |
Expired
|
| US9486588 | Automatic injection device with reset feature |
Jan, 2022
(2 years ago) |
Expired
|
| US6899699 | Automatic injection device with reset feature |
Jan, 2022
(2 years ago) |
Expired
|
| US8672898 | Automatic injection device with reset feature |
Jan, 2022
(2 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 Tresiba's patents.
Latest Legal Activities on Tresiba's Patents
Given below is the list of recent legal activities going on the following patents of Tresiba.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Apr, 2021 | US7615532 |
| Patent Term Extension Certificate Critical | 11 Sep, 2018 | US7615532 |
| Notice of Final Determination -Eligible | 14 Mar, 2018 | US7615532 |
| FDA Final Eligibility Letter Critical | 20 Sep, 2017 | US7615532 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 18 Apr, 2017 | US7615532 |
| Terminal Disclaimer Filed Critical | 14 Apr, 2017 | US7615532 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 13 Apr, 2017 | US7615532 |
| Terminal Disclaimer Filed Critical | 10 Apr, 2017 | US7615532 |
| PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED Critical | 10 Apr, 2017 | US7615532 |
| transaction for FDA Determination of Regulatory Review Period | 07 Dec, 2016 | US7615532 |
FDA has granted several exclusivities to Tresiba. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tresiba, 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 Tresiba.
Exclusivity Information
Tresiba holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Tresiba's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Dec 16, 2019 |
| New Chemical Entity Exclusivity(NCE) | Sep 25, 2020 |
Several oppositions have been filed on Tresiba'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 Tresiba's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tresiba patents.
Tresiba's Oppositions Filed in EPO
Tresiba 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 |
| 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 | Stöckeler, Ferdinand | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Ypsomed AG | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Ferring International Center S.A. | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | OWEN MUMFORD LIMITED | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Genentech, Inc. | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | COPERNICUS sp. zo.o. | Granted and Under Opposition |
| EP06121820A | May, 2010 | SANOFI-AVENTIS DEUTSCHLAND GMBH | 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 Tresiba 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 Tresiba's family patents as well as insights into ongoing legal events on those patents.
Tresiba's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tresiba's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 01, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tresiba Generics:
There are no approved generic versions for Tresiba as of now.
Alternative Brands for Tresiba
Tresiba which is used for lowering blood pressure and treating heart failure and kidney problems., has several other brand drugs using the same active ingredient (Insulin Degludec). 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.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Novo |
|
About Tresiba
Tresiba is a drug owned by Novo Nordisk Inc. It is used for lowering blood pressure and treating heart failure and kidney problems. Tresiba uses Insulin Degludec as an active ingredient. Tresiba was launched by Novo in 2018.
Approval Date:
Tresiba was approved by FDA for market use on 21 November, 2018.
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 Tresiba is 21 November, 2018, its NCE-1 date is estimated to be 26 September, 2019.
Active Ingredient:
Tresiba uses Insulin Degludec as the active ingredient. Check out other Drugs and Companies using Insulin Degludec ingredient
Treatment:
Tresiba is used for lowering blood pressure and treating heart failure and kidney problems.
Dosage:
Tresiba is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 600 UNITS/3ML (200 UNITS/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 300 UNITS/3ML (100 UNITS/ML) | SOLUTION | Prescription | SUBCUTANEOUS |
| 1000 UNITS/10ML (100 UNITS/ML) | SOLUTION | Prescription | SUBCUTANEOUS |