TRESIBA Drug Profile

Summary for Tradename: TRESIBA

High Confidence Patents:	53
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for TRESIBA
Recent Clinical Trials:	See clinical trials for TRESIBA

See drug prices for TRESIBA

Recent Clinical Trials for TRESIBA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Profil Institut fr Stoffwechselforschung GmbH	PHASE1
Gan and Lee Pharmaceuticals, USA	PHASE1
Novo Nordisk A/S	PHASE1

See all TRESIBA clinical trials

Pharmacology for TRESIBA

Established Pharmacologic Class	Insulin Analog
Chemical Structure	Insulin

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for TRESIBA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for TRESIBA Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2035-04-30	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2035-08-27	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2036-03-08	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2026-07-17	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2037-11-15	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2037-11-17	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for TRESIBA Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2034-04-30	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2038-06-27	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2037-05-24	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2036-12-05	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2037-10-13	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2038-11-02	Patent claims search

International Patents for TRESIBA

Country	Patent Number	Estimated Expiration
Canada	3104670
Russian Federation	2506957
China	101227942
Russian Federation	2388498
New Zealand	512244
Spain	2856187

Supplementary Protection Certificates for TRESIBA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1390036-0	Sweden		PRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
472	Finland
471	Finland
35/2013	Austria		PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC AND INSULIN ASPART UND BELIEBIGE ZN2+-KOMPLEXE DAVON; REGISTRATION NO/DATE: EU/1/12/806/001, EU/1/12/806/004, EU/1/12/806/005, EU/1/12/806/007, EU/1/12/806/008 (MITTEILUNG) 20180123
2013C/038	Belgium		PRODUCT NAME: INSULINE DEGLUDEC/INSULINE ASPARTE; AUTHORISATION NUMBER AND DATE: EU/1/12/806/001 20130123
C02107069/02	Switzerland		PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013

Market Dynamics and Financial Trajectory for TRESIBA

Last updated: February 19, 2026

What is TRESIBA, and what is its current market position?

TRESIBA (insulin degludec) is a long-acting basal insulin developed by Novo Nordisk. Approved by the FDA in 2015, it targets diabetes management by providing a consistent 24-hour insulin profile. As of 2023, TRESIBA is a leading long-acting insulin, holding approximately 25% of the global basal insulin market, which was valued at $12 billion in 2022 according to IQVIA data.

How does TRESIBA compare to competitors?

TRESIBA competes primarily with insulin glargine (such as Lantus, Basaglar, Toujeo) and other biosimilar basal insulins. Key comparison points include:

• Duration of action: TRESIBA lasts over 42 hours, allowing flexible dosing.
• Hypoglycemia risk: Lower incidence compared to some analogs.
• Dosing flexibility: No need for strict timing, advantageous in patient adherence.

In markets like the US and Europe, TRESIBA maintains a premium pricing position, with average annual costs around $7,000-$8,000 per patient, comparable with branded basal insulins.

What are the market drivers influencing TRESIBA's growth?

Increasing diabetes prevalence: The International Diabetes Federation estimates 537 million adults with diabetes in 2021, projected to reach 643 million by 2030. This growth expands the market for long-acting insulins.

Shift towards basal-bolus therapy: Increasing adoption of insulin analogs over human insulins boosts demand for TRESIBA.

Patient preference for dosing flexibility: TRESIBA's dosing profile aligns with patient-centric treatment approaches, fostering adherence.

Regulatory approvals: Expanded indications, including use in pediatric populations and type 2 diabetes, have driven uptake.

Emergence of biosimilars: Biosimilars to insulin glargine challenge TRESIBA's market share, but brand loyalty and clinical advantages sustain its position.[1]

What are the financial projections for TRESIBA over the next five years?

Revenue estimates:

• In 2022, TRESIBA generated approximately $2.2 billion globally.
• Compound annual growth rate (CAGR) projected at 8% from 2023 to 2027, driven by rising prevalence, expanding indications, and geographic expansion.

Market penetration forecasts:

Year	Estimated Revenue (USD billion)	Market Share (%)
2023	2.4	21
2024	2.6	22
2025	2.8	23
2026	3.0	24
2027	3.3	25

Key factors influencing growth:

• Increased adoption in emerging markets.
• Continued patent protections until at least 2030, delaying biosimilar competition.
• Clinical trial results supporting novel dosing regimens.

What threats and opportunities shape TRESIBA’s future?

Threats:

• Biosimilar entry: Biosimilars to insulin degludec could weaken pricing power post-2030.
• Pricing pressures: Governments in Europe and the US seek to reduce prescription costs, impacting margins.
• Alternative therapies: Advances in non-insulin treatments for diabetes, such as GLP-1 receptor antagonists, could reduce insulin dependence.

Opportunities:

• Expanded indications: Use in type 1 diabetes and newly approved pediatric populations.
• Combination therapies: Development of co-formulations (e.g., insulin degludec with GLP-1 drugs) increases patient convenience.
• Digital health integrations: Remote monitoring and dosing adjustments can improve patient outcomes and loyalty.

How do regulatory policies affect TRESIBA’s market trajectory?

Regulatory environments influence both approval and pricing strategies:

• FDA and EMA approvals: Continuous updates bolster confidence; recent approval for pediatric use expands market.
• Pricing regulations: Countries adopting value-based pricing could impact revenue.
• Patent extensions: Protects exclusivity until at least 2030, delaying biosimilar entry.

What are the implications for investors and R&D?

Investors should monitor Novo Nordisk’s pipeline, especially combination products and biosimilars. R&D investments focus on:

• Long-acting insulin analogs with improved profiles.
• Novel delivery systems (e.g., patch pumps).
• Digital health tools for personalized management.

Patent expiry dates and biosimilar filings will determine long-term revenue stability.

Key Takeaways

• TRESIBA is a leading long-acting insulin with a stable market share around 25%.
• The global basal insulin market surpasses $12 billion; TRESIBA’s revenue is expected to grow at approximately 8% CAGR through 2027.
• Patent protections until 2030 provide a barrier against biosimilar competition.
• Market expansion into emerging economies and pediatric indications drives revenue growth.
• Biosimilar competition and pricing policies are significant risks; innovation in combination therapies and digital health presents growth opportunities.

FAQs

1. When will biosimilar insulin degludec enter the market? Biosimilar filings are underway; expected availability post-2030 following patent expirations.

2. How does TRESIBA's dosing flexibility compare with competitors? TRESIBA offers greater flexibility, with no insulin peak and dosing window extending beyond 24 hours.

3. What approval expansions have been granted for TRESIBA? Recently approved for pediatric use and in some markets for first-line therapy, broadening patient access.

4. What factors could accelerate TRESIBA’s revenue growth? Increased adoption in emerging markets, higher prevalence of diabetes, and new combination formulations.

5. How might digital health integrations impact TRESIBA’s market? They can improve adherence, enable remote management, and foster loyalty, supporting sustained revenue.

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References

[1] IQVIA. (2022). Global Insulin Market Report. IQVIA Institute for Human Data Science.