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ZEGALOGUE (AUTOINJECTOR) Drug Patent Profile

When do Zegalogue (autoinjector) patents expire, and what generic alternatives are available?

Zegalogue (autoinjector) is a drug marketed by Zealand Pharma and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-three patent family members in twenty-four countries.

The generic ingredient in ZEGALOGUE (AUTOINJECTOR) is dasiglucagon hydrochloride. Two suppliers are listed for this compound. Additional details are available on the dasiglucagon hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Zegalogue (autoinjector)

Zegalogue (autoinjector) will be eligible for patent challenges on March 22, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

Indicators of Generic Entry

Summary for ZEGALOGUE (AUTOINJECTOR)

International Patents:	33
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
DailyMed Link:	ZEGALOGUE (AUTOINJECTOR) at DailyMed

Pharmacology for ZEGALOGUE (AUTOINJECTOR)

Drug Class	Antihypoglycemic Agent
Mechanism of Action	Glucagon Receptor Agonists
Physiological Effect	Increased Glycogenolysis

US Patents and Regulatory Information for ZEGALOGUE (AUTOINJECTOR)

ZEGALOGUE (AUTOINJECTOR) is protected by two US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes	11,795,204
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes	10,442,847		Y	Y
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes

International Patents for ZEGALOGUE (AUTOINJECTOR)

See the table below for patents covering ZEGALOGUE (AUTOINJECTOR) around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2875043	ANALOGUES DU GLUCAGON (GLUCAGON ANALOGUES)
Brazil	112015001451	análogos de glucagon
Japan	2019187419	グルカゴン類似体 (GLUCAGON ANALOGS)

ZEGALOGUE (AUTOINJECTOR) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZEGALOGUE (Dasiglucagon) Autoinjector

Introduction to ZEGALOGUE

ZEGALOGUE, also known as dasiglucagon, is a peptide-based medicine developed by Zealand Pharma A/S for the treatment of severe hypoglycemia in patients with diabetes. It has been approved by the U.S. Food and Drug Administration (FDA) for use in pediatric and adult patients aged 6 and above[1].

Market Context: Glucagon and Autoinjectors

The global glucagon market is experiencing significant growth, driven by the increasing prevalence of diabetes and the need for convenient and effective treatment options for severe hypoglycemia. The market size was valued at $278.5 million in 2022 and is projected to reach $470.8 million by 2030, growing at a CAGR of 6.8% during the forecast period[4].

Autoinjector Market Trends

The autoinjector market, which includes products like ZEGALOGUE, is also on the rise. This market is expected to reach $33 billion by 2036, with a CAGR of 17% from 2024 to 2036. The convenience and user-friendliness of autoinjectors are key factors driving their adoption among patients and healthcare providers[3].

Licensing and Development Agreement

Zealand Pharma A/S has entered into a global license and development agreement with Novo Nordisk A/S to commercialize ZEGALOGUE. This agreement includes an upfront payment, as well as development, regulatory, manufacturing, and sales-based milestones of up to DKK 290 million. Additionally, Zealand will receive high-single to low-double digit royalties on worldwide net sales of ZEGALOGUE[1].

Role of Novo Nordisk

Novo Nordisk, a major player in the glucagon market, is expanding its portfolio through strategic alliances. The partnership with Zealand Pharma is part of Novo Nordisk's strategy to enhance its presence in the treatment of severe hypoglycemia. This collaboration is expected to leverage Novo Nordisk's extensive distribution and marketing capabilities to increase the global reach of ZEGALOGUE[4].

Financial Trajectory of Zealand Pharma

Recent Financial Performance

Zealand Pharma has reported strong financial results for the first half of 2024. The company saw a significant increase in revenue, from DKK 24.0 million in H1 2023 to DKK 49.2 million in H1 2024. Despite net operating expenses increasing to DKK -558.7 million, the company's cash position has been substantially strengthened following a successful capital raise in June 2024, which raised gross proceeds of DKK 7 billion[2][5].

Investment in R&D and Obesity Portfolio

The capital raise has enabled Zealand Pharma to invest significantly in its research and development (R&D) activities, particularly in its obesity portfolio. The company has reported positive data from its amylin analog, petrelintide, which is seen as a potential alternative to GLP-1RA-based therapies for weight management. This investment is expected to accelerate the development of Zealand's differentiated obesity candidates and explore partnership opportunities[5].

Market Growth Drivers

Increasing Prevalence of Diabetes

The rising prevalence of diabetes globally is a major driver for the glucagon market. As the diabetic population grows, so does the demand for effective treatments for severe hypoglycemia. ZEGALOGUE, with its FDA approval and user-friendly autoinjector format, is well-positioned to meet this growing demand[4].

Novel Formulations and Delivery Systems

Market players are focusing on introducing novel drugs and delivery systems, such as liquid-stable formulations delivered via autoinjectors. For example, Tetris Pharma Ltd launched Ogluo, a glucagon prefilled autoinjector pen, in Denmark and Norway. Such innovations are expected to increase patient accessibility and drive market growth[4].

Reimbursement and Accessibility

European countries offer reimbursement for glucagon products, reducing the economic burden on diabetic patients and increasing affordability and accessibility. This favorable reimbursement environment is anticipated to bolster market growth in the region[4].

Competitive Landscape

Key Players

The global glucagon market is dominated by companies like Novo Nordisk A/S and Xeris Biopharma Holdings, Inc. These companies are focused on expanding their portfolios through strategic alliances and innovative product launches. The partnership between Zealand Pharma and Novo Nordisk is a significant move in this competitive landscape, enhancing the market presence of ZEGALOGUE[4].

Regional Market Dynamics

North America and Europe

North America is currently the dominant region in the glucagon market, with a market size of $239.2 million in 2022. Europe, however, is also a significant market, driven by favorable reimbursement policies and the launch of new products like Ogluo in Denmark and Norway[4].

Future Outlook

Market Projections

The global glucagon market is projected to grow from $297.8 million in 2023 to $470.8 million by 2030. The autoinjector segment, which includes ZEGALOGUE, is expected to continue its strong growth due to its convenience and user-friendliness[4].

Strategic Partnerships and Innovations

The future success of ZEGALOGUE will depend on the execution of the licensing agreement with Novo Nordisk and the continued innovation in delivery systems. Strategic partnerships and the introduction of novel formulations will be crucial in maintaining market competitiveness and driving growth.

Key Takeaways

• Market Growth: The global glucagon market is expected to grow significantly, driven by the increasing prevalence of diabetes and the adoption of autoinjectors.
• Licensing Agreement: The partnership between Zealand Pharma and Novo Nordisk is pivotal for the global commercialization of ZEGALOGUE.
• Financial Strength: Zealand Pharma's strong financial position, following a substantial capital raise, will support further R&D investments and accelerate the development of its obesity portfolio.
• Competitive Landscape: The market is dominated by Novo Nordisk and Xeris Biopharma, with Zealand Pharma positioning itself through strategic partnerships.
• Regional Dynamics: North America and Europe are key regions, with favorable reimbursement policies in Europe driving market growth.

FAQs

What is ZEGALOGUE used for?

ZEGALOGUE (dasiglucagon) is used for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 and above.

Who are the key players in the glucagon market?

The key players in the glucagon market include Novo Nordisk A/S and Xeris Biopharma Holdings, Inc., with Zealand Pharma A/S also playing a significant role through its partnership with Novo Nordisk.

What is the projected market size of the glucagon market by 2030?

The global glucagon market is projected to reach $470.8 million by 2030, growing at a CAGR of 6.8% from 2023 to 2030.

How does the autoinjector market impact ZEGALOGUE?

The autoinjector market, which is expected to reach $33 billion by 2036, significantly benefits ZEGALOGUE due to its user-friendly and convenient delivery format.

What is the significance of the licensing agreement between Zealand Pharma and Novo Nordisk?

The licensing agreement allows for the global commercialization of ZEGALOGUE, leveraging Novo Nordisk's extensive distribution and marketing capabilities, and includes significant financial milestones and royalties for Zealand Pharma.

Sources

1. Zealand Pharma Announces Global License and Development Agreement with Novo Nordisk for ZEGALOGUE®. Biospace.
2. Zealand Pharma Announces Financial Results for the First Half of 2024. GlobeNewswire.
3. Auto-injectors Global Trends Market Forecast. Drug Delivery Leader.
4. Glucagon Market Size, Share, Growth & Trends Analysis [2030]. Fortune Business Insights.
5. Zealand Pharma Announces Financial Results for the First Half of 2024. Zealand Pharma.