Zegalogue is a drug owned by Zealand Pharma Us Inc. It is protected by 2 US drug patents filed from 2021 to 2023 out of which none have expired yet. Zegalogue's patents will be open to challenges from 22 March, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 03, 2035. Details of Zegalogue's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US10442847 | Glucagon analogues |
Feb, 2035
(10 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11795204 | Glucagon analogues |
Jan, 2034
(9 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Zegalogue's patents.
Latest Legal Activities on Zegalogue's Patents
Given below is the list of recent legal activities going on the following patents of Zegalogue.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Patent eCofC Notification | 25 Jun, 2024 | US11795204 |
| Email Notification Critical | 25 Jun, 2024 | US11795204 |
| Patent eCofC Notification | 25 Jun, 2024 | US11795204 |
| Recordation of Patent eCertificate of Correction | 25 Jun, 2024 | US11795204 |
| Post Issue Communication - Certificate of Correction | 05 Jun, 2024 | US11795204 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US10442847 |
| Email Notification Critical | 24 Oct, 2023 | US11795204 |
| Patent Issue Date Used in PTA Calculation Critical | 24 Oct, 2023 | US11795204 |
| Mail Patent eGrant Notification | 24 Oct, 2023 | US11795204 |
| Recordation of Patent eGrant | 24 Oct, 2023 | US11795204 |
FDA has granted several exclusivities to Zegalogue. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zegalogue, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Zegalogue.
Exclusivity Information
Zegalogue holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Zegalogue's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 22, 2026 |
US patents provide insights into the exclusivity only within the United States, but Zegalogue is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Zegalogue's family patents as well as insights into ongoing legal events on those patents.
Zegalogue's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zegalogue's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 03, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zegalogue Generics:
There are no approved generic versions for Zegalogue as of now.
Alternative Brands for Zegalogue
Zegalogue which is used for managing low blood sugar levels in diabetic patients., has several other brand drugs in the same treatment category and using the same active ingredient (Dasiglucagon Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Zealand Pharma |
| |||
About Zegalogue
Zegalogue is a drug owned by Zealand Pharma Us Inc. It is used for managing low blood sugar levels in diabetic patients. Zegalogue uses Dasiglucagon Hydrochloride as an active ingredient. Zegalogue was launched by Zealand Pharma in 2021.
Approval Date:
Zegalogue was approved by FDA for market use on 22 March, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Zegalogue is 22 March, 2021, its NCE-1 date is estimated to be 22 March, 2025.
Active Ingredient:
Zegalogue uses Dasiglucagon Hydrochloride as the active ingredient. Check out other Drugs and Companies using Dasiglucagon Hydrochloride ingredient
Treatment:
Zegalogue is used for managing low blood sugar levels in diabetic patients.
Dosage:
Zegalogue is available in solution form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) | SOLUTION | Prescription | SUBCUTANEOUS |