Tresiba Patent Expiration

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, 7 months from now)

Active
USRE46363 Dial-down mechanism for wind-up pen
Aug, 2026

(1 year, 7 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, 1 month from now)

Active
US9616180 Automatic injection device with a top release mechanism
Jan, 2026

(1 year, 1 month from now)

Active
US9108002 Automatic injection device with a top release mechanism
Jan, 2026

(1 year, 1 month from now)

Active
US9861757 Injection device with an end of dose feedback mechanism
Jan, 2026

(1 year, 1 month from now)

Active
US10376652 Automatic injection device with a top release mechanism
Jan, 2026

(1 year, 1 month from now)

Active
US8684969 Injection device with torsion spring and rotatable display
Oct, 2025

(10 months from now)

Active
US7762994 Needle mounting system and a method for mounting a needle assembly
May, 2024

(6 months ago)

Expired
US8579869 Needle mounting system and a method for mounting a needle assembly
Jun, 2023

(1 year, 5 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.

Given below is the list of recent legal activities going on the following patents of Tresiba.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 21 Apr, 2021 US7615532
Patent Term Extension Certificate 11 Sep, 2018 US7615532
Notice of Final Determination -Eligible 14 Mar, 2018 US7615532
FDA Final Eligibility Letter 20 Sep, 2017 US7615532
PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED 18 Apr, 2017 US7615532
Terminal Disclaimer Filed 14 Apr, 2017 US7615532
Resp. to req. for info. sent under 37 CFR 1.750 13 Apr, 2017 US7615532
Terminal Disclaimer Filed 10 Apr, 2017 US7615532
PARALEGAL OR ELECTRONIC TERMINAL DISCLAIMER APPROVED 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

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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
Patent litigations
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

Tresiba has patent protection in a total of 16 countries. It's US patent count contributes only to 28.9% of its total global patent coverage. Click below to unlock the full patent family tree for Tresiba.

Family Patents

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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
Ryzodeg 70/30
Xultophy 100/3.6






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