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Last Updated: May 25, 2024

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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
Drug Prices for ZEGALOGUE

See drug prices for ZEGALOGUE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZEGALOGUE
Generic Entry Date for ZEGALOGUE*:
Constraining patent/regulatory exclusivity:
NDA:
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 ClassAntihypoglycemic Agent
Mechanism of ActionGlucagon Receptor Agonists
Physiological EffectIncreased 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

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
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 (AUTOINJECTOR) dasiglucagon hydrochloride SOLUTION;SUBCUTANEOUS 214231-002 Mar 22, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  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
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 13295035
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2015001451
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 78991
Estimated Expiration: ⤷  Sign Up

China

Patent: 4662038
Estimated Expiration: ⤷  Sign Up

Patent: 9456400
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 75043
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 3399
Estimated Expiration: ⤷  Sign Up

Patent: 1590058
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 75043
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 10787
Estimated Expiration: ⤷  Sign Up

India

Patent: 4DEN2015
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6554
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 34927
Estimated Expiration: ⤷  Sign Up

Patent: 15524419
Estimated Expiration: ⤷  Sign Up

Patent: 19187419
Estimated Expiration: ⤷  Sign Up

Patent: 22023029
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 0671
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 6957
Estimated Expiration: ⤷  Sign Up

Patent: 15000990
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 4043
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 015500115
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 75043
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201500375P
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1702364
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2129235
Estimated Expiration: ⤷  Sign Up

Patent: 150032912
Estimated Expiration: ⤷  Sign Up

Patent: 200080331
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 20111
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 42682
Estimated Expiration: ⤷  Sign Up

Patent: 1404785
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 7103
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.

Country Patent Number Title Estimated Expiration
Mexico 2015000990 ANALOGOS DEL GLUCAGON. (GLUCAGON ANALOGUES.) ⤷  Sign Up
Israel 236554 אנלוגים של גלוקגונים (Glucagon analogues) ⤷  Sign Up
South Korea 20200080331 글루카곤 유사체 (GLUCAGON ANALOGUES) ⤷  Sign Up
Brazil 112015001451 análogos de glucagon ⤷  Sign Up
Japan 2019187419 グルカゴン類似体 (GLUCAGON ANALOGS) ⤷  Sign Up
Hong Kong 1210787 胰高血糖素類似物 (GLUCAGON ANALOGUES) ⤷  Sign Up
Spain 2620111 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.