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
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
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 Class | Antihypoglycemic Agent |
Mechanism of Action | Glucagon Receptor Agonists |
Physiological Effect | Increased Glycogenolysis |
Anatomical Therapeutic Chemical (ATC) Classes for ZEGALOGUE
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF TREATING DIABETIC HYPOGLYCEMIA
FDA Regulatory Exclusivity protecting ZEGALOGUE
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Zealand Pharma | ZEGALOGUE (AUTOINJECTOR) | dasiglucagon hydrochloride | SOLUTION;SUBCUTANEOUS | 214231-002 | Mar 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Zealand Pharma | ZEGALOGUE | dasiglucagon hydrochloride | SOLUTION;SUBCUTANEOUS | 214231-001 | Mar 22, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>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: ⤷ Try a Trial
Australia
Patent: 13295035
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2015001451
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 78991
Estimated Expiration: ⤷ Try a Trial
China
Patent: 4662038
Estimated Expiration: ⤷ Try a Trial
Patent: 9456400
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 75043
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 3399
Estimated Expiration: ⤷ Try a Trial
Patent: 1590058
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 75043
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 10787
Estimated Expiration: ⤷ Try a Trial
India
Patent: 4DEN2015
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 6554
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 34927
Estimated Expiration: ⤷ Try a Trial
Patent: 15524419
Estimated Expiration: ⤷ Try a Trial
Patent: 19187419
Estimated Expiration: ⤷ Try a Trial
Patent: 22023029
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 0671
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 6957
Estimated Expiration: ⤷ Try a Trial
Patent: 15000990
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 4043
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 015500115
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 75043
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201500375P
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1702364
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2129235
Estimated Expiration: ⤷ Try a Trial
Patent: 150032912
Estimated Expiration: ⤷ Try a Trial
Patent: 200080331
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 20111
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 42682
Estimated Expiration: ⤷ Try a Trial
Patent: 1404785
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 7103
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2014016300 | ⤷ Try a Trial | |
Denmark | 2875043 | ⤷ Try a Trial | |
Malaysia | 170671 | GLUCAGON ANALOGUES | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |