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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

Anatomical Therapeutic Chemical (ATC) Classes for ZEGALOGUE

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 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.

Patents protecting ZEGALOGUE

FDA Regulatory Exclusivity protecting ZEGALOGUE

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
Singapore	11201500375P	GLUCAGON ANALOGUES
South Africa	201702364	GLUCAGON ANALOGUES
Japan	2019187419	グルカゴン類似体 (GLUCAGON ANALOGS)
South Korea	20150032912	GLUCAGON ANALOGUES
World Intellectual Property Organization (WIPO)	2014016300
New Zealand	704043	Glucagon analogues