Dasiglucagon hydrochloride - Generic Drug Details

What are the generic sources for dasiglucagon hydrochloride and what is the scope of patent protection?

Dasiglucagon hydrochloride is the generic ingredient in two branded drugs marketed by Zealand Pharma and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dasiglucagon hydrochloride has thirty-six patent family members in twenty-seven countries.

Two suppliers are listed for this compound.

Summary for dasiglucagon hydrochloride

International Patents:	36
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	20
DailyMed Link:	dasiglucagon hydrochloride at DailyMed

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

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.

Recent Clinical Trials for dasiglucagon hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Inreda Diabetic B.V.	Phase 2
Filip Krag Knop	Phase 2
Steno Diabetes Center Copenhagen	Phase 2

See all dasiglucagon hydrochloride clinical trials

Pharmacology for dasiglucagon hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for dasiglucagon hydrochloride

H04AA	Glycogenolytic hormones
H04A	GLYCOGENOLYTIC HORMONES
H04	PANCREATIC HORMONES
H	Systemic hormonal preparations, excluding sex hormones and insulins

H04AA	Glycogenolytic hormones
H04A	GLYCOGENOLYTIC HORMONES
H04	PANCREATIC HORMONES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for dasiglucagon hydrochloride

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

International Patents for dasiglucagon hydrochloride

Country	Patent Number	Title	Estimated Expiration
Denmark	2875043
Taiwan	201404785	Glucagon analogues
Mexico	356957	ANALOGOS DEL GLUCAGON. (GLUCAGON ANALOGUES.)
Japan	2019187419	グルカゴン類似体 (GLUCAGON ANALOGS)
Malaysia	170671	GLUCAGON ANALOGUES
Japan	2015524419	グルカゴン類似体

Supplementary Protection Certificates for dasiglucagon hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2875043	301294	Netherlands		PRODUCT NAME: DASIGLUCAGON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, ZOALS DASIGLUCAGON HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/24/1829 20240725
2875043	122024000057	Germany		PRODUCT NAME: DASIGLUCAGON IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1829 20240724
2875043	CR 2024 00043	Denmark		PRODUCT NAME: DASIGLUCAGON ELLER ET FARMACEUTISK SALT ELLER SOLVAT DERAF, SASOM DASIGLUCAGONHYDROCHLORID; REG. NO/DATE: EU/1/24/1829 20240725

Market Dynamics and Financial Trajectory for Dasiglucagon Hydrochloride

Introduction to Dasiglucagon Hydrochloride

Dasiglucagon hydrochloride, marketed under the brand name Zegalogue, is a glucagon receptor agonist developed by Zealand Pharma for the treatment of severe hypoglycemia in patients with diabetes and other conditions such as congenital hyperinsulinism (CHI).

Regulatory Approvals and Market Access

Dasiglucagon has received significant regulatory approvals that have paved the way for its market entry. In the U.S., the FDA approved dasiglucagon for the treatment of severe hypoglycemia in patients with diabetes aged six years and above, with a ready-to-use product presentation that includes a prefilled syringe and an autoinjector[1].

In Europe, the European Commission granted marketing authorization for dasiglucagon under the brand name Zegalogue for the same indication, with commercialization responsibilities held by Novo Nordisk[2].

Clinical Efficacy and Market Need

Dasiglucagon has demonstrated robust clinical efficacy in raising blood glucose levels significantly faster than placebo. In clinical studies, dasiglucagon showed a median time to glucose recovery of 10 minutes, compared to 30-40 minutes with placebo, highlighting its potential to prevent serious complications of severe hypoglycemia[1].

This rapid recovery is crucial for patients, especially those with diabetes, and addresses a significant market need for a reliable and easy-to-administer treatment for severe hypoglycemia.

Product Differentiation

Dasiglucagon stands out from traditional glucagon products due to its ready-to-use formulation, which eliminates the need for reconstitution. This feature reduces the likelihood of medication errors and provides a more portable and convenient treatment option that can be stored at room temperature for up to 12 consecutive months[1].

Financial Performance and Projections

Zealand Pharma's financial position has been bolstered by several key developments related to dasiglucagon. The company completed a significant equity offering in June 2024, raising gross proceeds of USD 1 billion, which will support the advancement of its proprietary obesity programs, including those related to dasiglucagon[2].

Revenue and Expenses

In the first half of 2024, Zealand Pharma reported revenue of DKK 49.2 million, up from DKK 24.0 million in the same period of 2023. Net operating expenses increased to DKK 558.7 million, reflecting the company's investments in research and development, sales and marketing, and general administrative activities[2].

Cash Position and Funding

As of June 30, 2024, Zealand Pharma's cash position, including cash, cash equivalents, and marketable securities, stood at DKK 9.7 billion. This solid financial position is expected to support the continued development and commercialization of dasiglucagon, as well as other pipeline assets[2].

Economic Impact and Cost Considerations

Studies have shown that dasiglucagon can reduce costs associated with the treatment of severe hypoglycemia compared to available glucagon treatments. The ready-to-use formulation and reduced need for emergency medical services contribute to these cost savings[3].

Future Milestones and Expansion

Dasiglucagon is also under review for the prevention and treatment of hypoglycemia in pediatric patients with congenital hyperinsulinism (CHI), with a PDUFA date set for December 30, 2023. If approved, this will expand the drug's market reach and further solidify its position in the treatment of hypoglycemia-related conditions[5].

Partnerships and Commercialization

Zealand Pharma is engaged in partnership discussions for the commercialization of dasiglucagon, particularly for its use in CHI. The company's collaboration with Novo Nordisk for the commercialization of Zegalogue in Europe is a significant step in ensuring broad market access[2].

Challenges and Uncertainties

While dasiglucagon has shown a favorable benefit-risk profile, there are some uncertainties and challenges. The long-term immunogenicity risk of repeated dosing is unknown and will be monitored through postmarket surveillance. However, the available data suggest a low incidence of antibody formation, and the safety profile is generally well-tolerated, with mild to moderate tolerability issues being the most common adverse reactions[1].

Key Takeaways

• Regulatory Approvals: Dasiglucagon has received FDA and European Commission approvals for treating severe hypoglycemia.
• Clinical Efficacy: Demonstrated rapid recovery of blood glucose levels, outperforming placebo.
• Product Differentiation: Ready-to-use formulation reduces medication errors and enhances portability.
• Financial Performance: Strong financial position supported by recent equity offerings.
• Economic Impact: Potential to reduce treatment costs for severe hypoglycemia.
• Future Milestones: Under review for CHI treatment, with ongoing partnership discussions.

FAQs

Q: What is dasiglucagon hydrochloride used for?

A: Dasiglucagon hydrochloride, marketed as Zegalogue, is used for the treatment of severe hypoglycemia in patients with diabetes aged six years and above.

Q: How does dasiglucagon differ from traditional glucagon products?

A: Dasiglucagon is a ready-to-use product that does not require reconstitution, reducing the risk of medication errors and providing a more convenient treatment option.

Q: What are the common adverse reactions associated with dasiglucagon?

A: The most common adverse reactions include headache, nausea, vomiting, and diarrhea, which are generally mild to moderate.

Q: Is dasiglucagon approved for use in congenital hyperinsulinism (CHI)?

A: Dasiglucagon is under review for the prevention and treatment of hypoglycemia in pediatric patients with CHI, with a PDUFA date set for December 30, 2023.

Q: How does dasiglucagon impact the economic costs of treating severe hypoglycemia?

A: Studies indicate that dasiglucagon can reduce costs associated with the treatment of severe hypoglycemia by minimizing the need for emergency medical services and other interventions.

Cited Sources

1. FDA Summary Review: "Dasiglucagon NDA 214231 Summary Basis for Regulatory Action" - FDA.
2. Zealand Pharma Interim Report: "Zealand Pharma Announces Financial Results for the First Half of 2024" - Zealand Pharma.
3. Economic Impact Study: "Dasiglucagon demonstrates reduced costs in the treatment of severe hypoglycemia" - PubMed.
4. Pharmacology and Clinical Pharmacology: "Dasiglucagon NDA 214231" - FDA.
5. Zealand Pharma Q3 Interim Report: "Zealand Pharma Announces Financial Results for the First Nine Months of 2023" - Zealand Pharma.