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ZEGALOGUE Drug Patent Profile

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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

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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

Drug patent expirations by year for ZEGALOGUE

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

Generic Entry Date for ZEGALOGUE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZEGALOGUE is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Glucagon analogues
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING DIABETIC HYPOGLYCEMIA

FDA Regulatory Exclusivity protecting ZEGALOGUE

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zealand Pharma	ZEGALOGUE (AUTOINJECTOR)	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-002	Mar 22, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-001	Mar 22, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Zealand Pharma	ZEGALOGUE	dasiglucagon hydrochloride	SOLUTION;SUBCUTANEOUS	214231-001	Mar 22, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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

Patent: 1866
Patent: ANALOGOS DEL GLUCAGON
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 13295035
Patent: Glucagon analogues
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2015001451
Patent: análogos de glucagon
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 78991
Patent: ANALOGUES DU GLUCAGON (GLUCAGON ANALOGUES)
Estimated Expiration: ⤷ Sign Up

China

Patent: 4662038
Patent: Glucagon analogues
Estimated Expiration: ⤷ Sign Up

Patent: 9456400
Patent: 胰高血糖素类似物 (GLUCAGON ANALOGUES)
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 75043
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 3399
Patent: АНАЛОГИ ГЛЮКАГОНА С ПОВЫШЕННОЙ РАСТВОРИМОСТЬЮ И/ИЛИ СТАБИЛЬНОСТЬЮ И ИХ ПРИМЕНЕНИЕ (GLUCAGON ANALOGUES WITH INCREASED SOLUBILITY AND/OR STABILITY AND USE THEREOF)
Estimated Expiration: ⤷ Sign Up

Patent: 1590058
Patent: АНАЛОГИ ГЛЮКАГОНА
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 75043
Patent: ANALOGUES DU GLUCAGON (GLUCAGON ANALOGUES)
Estimated Expiration: ⤷ Sign Up

Hong Kong

Patent: 10787
Patent: 胰高血糖素類似物 (GLUCAGON ANALOGUES)
Estimated Expiration: ⤷ Sign Up

India

Patent: 4DEN2015
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 6554
Patent: אנלוגים של גלוקגונים (Glucagon analogues)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 34927
Estimated Expiration: ⤷ Sign Up

Patent: 15524419
Patent: グルカゴン類似体
Estimated Expiration: ⤷ Sign Up

Patent: 19187419
Patent: グルカゴン類似体 (GLUCAGON ANALOGS)
Estimated Expiration: ⤷ Sign Up

Patent: 22023029
Patent: グルカゴン類似体
Estimated Expiration: ⤷ Sign Up

Malaysia

Patent: 0671
Patent: GLUCAGON ANALOGUES
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 6957
Patent: ANALOGOS DEL GLUCAGON. (GLUCAGON ANALOGUES.)
Estimated Expiration: ⤷ Sign Up

Patent: 15000990
Patent: ANALOGOS DEL GLUCAGON. (GLUCAGON ANALOGUES.)
Estimated Expiration: ⤷ Sign Up

New Zealand

Patent: 4043
Patent: Glucagon analogues
Estimated Expiration: ⤷ Sign Up

Philippines

Patent: 015500115
Patent: GLUCAGON ANALOGUES
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 75043
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 201500375P
Patent: GLUCAGON ANALOGUES
Estimated Expiration: ⤷ Sign Up

South Africa

Patent: 1702364
Patent: GLUCAGON ANALOGUES
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 2129235
Estimated Expiration: ⤷ Sign Up

Patent: 150032912
Patent: GLUCAGON ANALOGUES
Estimated Expiration: ⤷ Sign Up

Patent: 200080331
Patent: 글루카곤 유사체 (GLUCAGON ANALOGUES)
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 20111
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 42682
Estimated Expiration: ⤷ Sign Up

Patent: 1404785
Patent: Glucagon analogues
Estimated Expiration: ⤷ Sign Up

Ukraine

Patent: 7103
Patent: СПОЛУКА, ЯКА МАЄ АКТИВНІСТЬ АГОНІСТА ГЛЮКАГОНУ (GLUCAGON ANALOGUES)
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
South Korea	102129235		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2014016300		⤷ Sign Up
Denmark	2875043		⤷ Sign Up
China	104662038	Glucagon analogues	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration