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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZEGALOGUE
*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
| 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
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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 109456400 | 胰高血糖素类似物 (GLUCAGON ANALOGUES) | ⤷ Sign Up |
| Canada | 2878991 | ANALOGUES DU GLUCAGON (GLUCAGON ANALOGUES) | ⤷ Sign Up |
| China | 104662038 | Glucagon analogues | ⤷ Sign Up |
| Australia | 2013295035 | Glucagon analogues | ⤷ Sign Up |
| India | 544DEN2015 | ⤷ Sign Up | |
| Japan | 2022023029 | グルカゴン類似体 | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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