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ZEGALOGUE Drug Patent Profile

When do Zegalogue patents expire, and when can generic versions of Zegalogue launch?

Zegalogue 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 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

Zegalogue 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 3, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ZEGALOGUE

International Patents:	33
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Drug Prices:	Drug price information for ZEGALOGUE
What excipients (inactive ingredients) are in ZEGALOGUE?	ZEGALOGUE excipients list
DailyMed Link:	ZEGALOGUE at DailyMed

See drug prices for ZEGALOGUE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZEGALOGUE

NDA:

214231

Dosage:

SOLUTION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ZEGALOGUE

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

US Patents and Regulatory Information for ZEGALOGUE

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

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-001	Mar 22, 2021		RX	Yes	Yes
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-001	Mar 22, 2021		RX	Yes	Yes			Y	Y
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-001	Mar 22, 2021		RX	Yes	Yes
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes			Y	Y

International Patents for ZEGALOGUE

When does loss-of-exclusivity occur for ZEGALOGUE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

India

Israel

Japan

Malaysia

Mexico

New Zealand

Philippines

Poland

Singapore

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZEGALOGUE 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)
Eurasian Patent Organization	201590058	АНАЛОГИ ГЛЮКАГОНА
South Korea	20200080331	글루카곤 유사체 (GLUCAGON ANALOGUES)
Israel	236554	אנלוגים של גלוקגונים (Glucagon analogues)
Philippines	12015500115	GLUCAGON ANALOGUES

ZEGALOGUE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZEGALOGUE (Dasiglucagon)

Introduction

ZEGALOGUE, also known as dasiglucagon, is a glucagon analog developed by Zealand Pharma for the treatment of severe hypoglycemia in patients with diabetes. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its launch, partnerships, financial performance, and market impact.

Market Need and Demand

The global glucagon market is driven by the rising prevalence of diabetes and the associated risk of severe hypoglycemia episodes. Studies indicate that a significant portion of insulin-treated patients experience hypoglycemic episodes, making the demand for effective rescue therapies like ZEGALOGUE increasingly important[4].

Launch and Initial Challenges

ZEGALOGUE received FDA approval in March 2022 for the treatment of severe hypoglycemia in patients with diabetes. However, the initial launch faced significant challenges, with sales failing to meet expectations. This led Zealand Pharma to restructure its commercial operations, including a substantial reduction in its U.S. workforce and a scaling back of operating expenses[1].

Partnership with Novo Nordisk

To revitalize the launch, Zealand Pharma entered into a global license and development agreement with Novo Nordisk. This partnership allowed Novo Nordisk to take over the marketing and commercialization of ZEGALOGUE, while Zealand retained control over certain regulatory, development, and manufacturing activities outside the U.S. The deal included an upfront payment of 25 million Danish kroner ($3.3 million) and potential milestones of up to 45 million kroner ($6 million)[1].

Financial Impact of the Partnership

The partnership with Novo Nordisk provided Zealand Pharma with immediate financial relief but did not alter the company's earnings forecast for 2022. Despite this, the agreement includes long-term potential sales-based milestones and tiered royalties, which could amount to up to 220 million kroner ($29.25 million) for Zealand Pharma[1].

Budget Impact and Cost Savings

A budget impact analysis conducted by Boston Healthcare Associates revealed that ZEGALOGUE could significantly reduce healthcare costs associated with severe hypoglycemia. The analysis suggested that ZEGALOGUE could lower total annual treatment costs by $3.3 million to $7.3 million per 1 million people, depending on the comparison with other glucagon treatments. It also highlighted potential savings in emergency department visits and hospitalizations[3].

Market Competition and Growth

The global glucagon market, dominated by the hypoglycemia segment, is projected to grow from $297.8 million in 2023 to $470.8 million by 2030, with a CAGR of 6.8%. Key players like Novo Nordisk and Xeris Biopharma Holdings are driving this growth through strategic alliances and the introduction of novel drugs. The North American market, in particular, is expected to remain a significant contributor due to its large diabetic population and growing awareness of severe hypoglycemia[4].

Distribution and Accessibility

The market is segmented by distribution channels, with drug stores and retail pharmacies currently dominating. However, online pharmacies are expected to grow at the highest CAGR during the forecast period due to improved accessibility and quality of services. This shift is likely to enhance the reach and accessibility of ZEGALOGUE and other glucagon products[4].

Zealand Pharma's Financial Performance

In the first half of 2024, Zealand Pharma reported strong progress in its R&D pipeline, particularly in obesity treatments. The company's financial results showed revenue of 49.2 million DKK (approximately $6.5 million USD) and a cash position of 9,747.7 million DKK (approximately $1.3 billion USD) as of June 30, 2024. Despite significant net operating expenses, the company's financial position is bolstered by a substantial capital raise in June 2024[2][5].

Future Outlook

Zealand Pharma is poised to continue investing in its R&D pipeline, including its obesity candidates, backed by a solid financial position. The partnership with Novo Nordisk is expected to enhance the commercial performance of ZEGALOGUE, although the full impact will be observed over the long term. With the global glucagon market on a growth trajectory, ZEGALOGUE is well-positioned to capture a significant share, especially given its potential to reduce healthcare costs and improve patient outcomes[2][3].

Key Takeaways

• Market Need: The rising prevalence of diabetes and severe hypoglycemia episodes drive the demand for effective rescue therapies like ZEGALOGUE.
• Partnership: The agreement with Novo Nordisk is crucial for the commercial success of ZEGALOGUE.
• Financial Impact: The partnership provides immediate and potential long-term financial benefits for Zealand Pharma.
• Cost Savings: ZEGALOGUE can significantly reduce healthcare costs associated with severe hypoglycemia.
• Market Growth: The global glucagon market is expected to grow, with North America being a key region.
• Distribution: Online pharmacies are expected to play a larger role in the distribution of glucagon products.

FAQs

Q: What is ZEGALOGUE, and what is it used for?

A: ZEGALOGUE, or dasiglucagon, is a glucagon analog used for the treatment of severe hypoglycemia in patients with diabetes.

Q: Why did Zealand Pharma partner with Novo Nordisk for ZEGALOGUE?

A: Zealand Pharma partnered with Novo Nordisk to revitalize the launch of ZEGALOGUE, which had initially failed to meet sales expectations. Novo Nordisk took over the marketing and commercialization efforts.

Q: What are the potential financial benefits of the partnership for Zealand Pharma?

A: The partnership includes an upfront payment and potential milestones and royalties that could amount to up to 220 million Danish kroner ($29.25 million).

Q: How does ZEGALOGUE impact healthcare costs?

A: According to a budget impact analysis, ZEGALOGUE can reduce total annual treatment costs and lower the costs of emergency department visits and hospitalizations compared to other glucagon treatments.

Q: What is the projected growth of the global glucagon market?

A: The global glucagon market is projected to grow from $297.8 million in 2023 to $470.8 million by 2030, with a CAGR of 6.8%.

Sources

1. FiercePharma: "Zealand summons Novo Nordisk to help salvage diabetes launch"
2. Zealand Pharma: "Zealand Pharma Announces Financial Results for the First Half of 2024"
3. Managed Healthcare Executive: "Budget Impact Analysis Shows Zegalogue Could Cut Costs for Severe Hypoglycemia"
4. Fortune Business Insights: "Glucagon Market Size, Share, Growth & Trends Analysis [2030]"
5. GlobeNewswire: "Zealand Pharma Announces Financial Results for the First Half of 2024"