TRESIBA Drug Profile

Summary for Tradename: TRESIBA

High Confidence Patents:	6
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for TRESIBA
Recent Clinical Trials:	See clinical trials for TRESIBA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TRESIBA

See drug prices for TRESIBA

Recent Clinical Trials for TRESIBA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Phase 3
The Cleveland Clinic	Phase 4
Novo Nordisk A/S	Phase 1

See all TRESIBA clinical trials

Recent Litigation for TRESIBA

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
NOVO NORDISK INC. v. RIO BIOPHARMACEUTICALS, INC.	2024-02-05
Novo Nordisk, Inc. v. Mylan Pharmaceuticals, Inc.	2022-08-08
In Re: Ozempic (Semaglutide) Patent Litigation	2022-08-05

See all TRESIBA litigation

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. General brand-side disclosures

These patents were identified from searching 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 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		2026-07-17	Company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2037-11-17	Company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2037-02-24	Company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2039-01-17	Company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2037-11-28	Company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2025-01-21	Company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2021-01-05	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		2033-04-30	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2040-04-01	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2033-03-14	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2035-12-09	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2034-01-09	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2033-03-15	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2035-10-27	Patent claims search

International Patents for TRESIBA

Country	Patent Number	Estimated Expiration
China	101227943
China	100571805
Denmark	1819382
Israel	182613
Russian Federation	2401133
South Korea	20120026629
World Intellectual Property Organization (WIPO)	2007017052

Supplementary Protection Certificates for TRESIBA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
13C0035	France		PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
122013000061	Germany		PRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
2013/34	Ireland		PRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
2013/034	Ireland		PRODUCT NAME: INSULIN DEGLUDEC; NAT REGISTRATION NO/DATE: EU/1/12/807-001, 004, 005, 007-009, 012, 013 015 20130121
132013902172094	Italy		PRODUCT NAME: INSULINA DEGLUDEC/INSULINA ASPART(RYZODEG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/806/001-004-005-007-008, 20130121
132013902170499	Italy		PRODUCT NAME: INSULINA DEGLUDEC(TRESIBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/807/001-4-5-7-8-9-12-13-15, 20130121
138 5015-2013	Slovakia		PRODUCT NAME: INZULIN DEGLUDEK; REGISTRATION NO/DATE: EU/1/12/807/001 - EU/1/12/807/015 20130121

Market Dynamics and Financial Trajectory for the Biologic Drug: Tresiba

Introduction

Tresiba, developed by Novo Nordisk, is a long-acting basal insulin analog (insulin degludec) that has significantly impacted the diabetes care market. This article delves into the market dynamics and financial trajectory of Tresiba, highlighting its performance, market share, and the factors influencing its success.

Market Position and Share

Tresiba has established a strong presence in the global basal insulin market. As of 2018, Tresiba held a market share of 44% in Japan and contributed to Novo Nordisk's overall market share of 52% in the basal insulin segment in that country[1].

In the US, Tresiba's market share has been steadily increasing. Following the update of its label in March 2018, Tresiba achieved a market share of 14% in the US basal insulin market, with Novo Nordisk's total market share in this segment reaching 36%[1]. Additionally, Tresiba's new-to-brand prescription market share settled at 12%, with a total prescription share of 7.3% in the US basal insulin market[4].

Commercial Performance

Tresiba's commercial performance has been robust. In the first nine months of 2018, sales of Tresiba increased by 8% to DKK 5.9 billion (15% in local currencies)[1]. This growth was part of a broader trend where Novo Nordisk's diabetes care segment, which includes Tresiba, saw sales increase by 4% in local currencies[1].

In 2017, the inclusion of Tresiba in CVS's commercial formulary significantly boosted its sales, leading to a 174% increase in Tresiba sales to 1.5 billion Danish kroner ($220 million) for the first quarter[4]. This surge was driven by a massive increase in new-to-brand scripts following the CVS contract changes.

Financial Impact

The financial performance of Tresiba has been a key contributor to Novo Nordisk's overall financial health. The company's operating profit increased by 8% in Danish kroner and by 13% at constant exchange rates (CER) to DKK 58.6 billion in 2021, partly due to the strong sales of Tresiba and other diabetes care products[2].

In 2023, Novo Nordisk reported a significant increase in net sales, with a 31% growth to DKK 232.261 billion, driven by the continued success of its diabetes care products, including Tresiba. The operating profit for 2023 was DKK 102.574 billion, reflecting a 37% increase from the previous year[5].

Market Dynamics and Competitive Landscape

The basal insulin market is highly competitive, with major players like Novo Nordisk, Sanofi, and Eli Lilly. Tresiba's success can be attributed to several factors, including its favorable clinical profile, which reduces the risk of severe hypoglycemia, a significant concern for patients with diabetes[1].

The launch of Eli Lilly's Basaglar, a follow-on version of Sanofi's Lantus, posed a competitive challenge, but Tresiba maintained its market position through strong formulary coverage and direct-to-consumer advertising. As of 2017, Tresiba had around 70% access for patients in commercial channels and Medicare Part D combined[4].

Regulatory and Clinical Endorsements

Tresiba has received strong endorsements from regulatory and clinical bodies. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) updated their treatment guidelines in 2018 to recommend Tresiba as one of the preferred products within the basal insulin segment[1].

Marketing and Awareness Campaigns

Novo Nordisk has invested significantly in marketing and awareness campaigns for Tresiba. The 'Hypos Matter' campaign, which included a virtual reality experience at the EASD congress, aimed to raise awareness about the impact of hypoglycemic events and the benefits of Tresiba in reducing these risks[1].

Future Outlook

The future outlook for Tresiba remains positive. Novo Nordisk expects sales growth to be between 18-26% at CER and operating profit growth to be between 21-29% at CER for 2024[5]. This growth is driven by the increasing demand for effective diabetes treatments and the company's strategic alignment of R&D investments to address unmet medical needs.

Investment Trends in Pharmaceutical Research

The growing patient population with chronic diseases, including diabetes, has led to a surge in investment in new diabetes drugs. Pharmaceutical companies like Novo Nordisk are strategically investing in R&D to develop innovative products like Tresiba, shaping the future trajectory of healthcare innovation[3].

Key Takeaways

• Strong Market Position: Tresiba has a significant market share in the basal insulin segment globally, particularly in Japan and the US.
• Robust Sales Growth: Tresiba's sales have consistently increased, contributing to Novo Nordisk's overall financial performance.
• Competitive Advantage: Tresiba's clinical profile, reducing the risk of severe hypoglycemia, and strong formulary coverage have been key to its success.
• Regulatory Endorsements: Recommendations from EASD and ADA have further solidified Tresiba's position in treatment guidelines.
• Future Growth: Positive outlook with expected sales and operating profit growth in the coming years.

FAQs

What is Tresiba and how does it differ from other basal insulins?

Tresiba is a long-acting basal insulin analog (insulin degludec) developed by Novo Nordisk. It differs from other basal insulins by its unique mechanism of action, which reduces the risk of severe hypoglycemia.

How has Tresiba performed in the US market?

In the US, Tresiba has achieved a market share of 14% in the basal insulin market and a new-to-brand prescription market share of 12%, with a total prescription share of 7.3% as of 2018[1][4].

What factors have contributed to Tresiba's success?

Tresiba's success can be attributed to its favorable clinical profile, strong formulary coverage, direct-to-consumer advertising, and regulatory endorsements from bodies like EASD and ADA.

How does Tresiba compare to other diabetes treatments in terms of market share?

Tresiba holds a significant market share in the basal insulin segment, particularly in Japan and the US. It competes with other major players like Sanofi's Lantus and Eli Lilly's Basaglar but has maintained its position through its clinical benefits and marketing efforts.

What is the future outlook for Tresiba?

The future outlook for Tresiba is positive, with expected sales growth between 18-26% at CER and operating profit growth between 21-29% at CER for 2024, driven by increasing demand for effective diabetes treatments and strategic R&D investments[5].

Sources

1. Novo Nordisk - SHARE UK Q3 2018 Quarterly Investor Update Magazine[1].
2. Novo Nordisk - Financial report for the period 1 January 2021 to 31 December 2021[2].
3. DrugBank Blog - Investment Trends in Pharmaceutical Research[3].
4. BioPharma Dive - CVS inclusion helps Novo gain market share[4].
5. GlobeNewswire - Financial report for the period 1 January 2023 to 31 December 2023[5].