Veozah is a drug owned by Astellas Pharma Us Inc. It is protected by 4 US drug patents filed in 2023 out of which none have expired yet. Veozah's patents will be open to challenges from 13 May, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 28, 2034. Details of Veozah'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. | |||
| US9422299 | Substituted [1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists |
Mar, 2034
(9 years from now) | Active |
| US8871761 | NK-3 receptor selective antagonist compounds, pharmaceutical composition and methods for use in NK-3 receptors mediated disorders |
Apr, 2031
(6 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). | |||
| US10836768 | N-acyl-(3-substituted)-(8-substituted)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists |
Mar, 2034
(9 years from now) | Active |
| US9987274 | N-acyl-(3-substituted)-(8-substituted)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazines as selective NK-3 receptor antagonists |
Mar, 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 Veozah's patents.
Latest Legal Activities on Veozah's Patents
Given below is the list of recent legal activities going on the following patents of Veozah.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 May, 2024 | US10836768 |
| Second letter to regulating agency to determine regulatory review period | 14 Mar, 2024 | US9987274 |
| Second letter to regulating agency to determine regulatory review period | 14 Mar, 2024 | US10836768 |
| Second letter to regulating agency to determine regulatory review period | 14 Mar, 2024 | US9422299 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Feb, 2024 | US9422299 |
| Letter from FDA or Dept of Agriculture re PTE application | 06 Feb, 2024 | US9422299 |
| Letter from FDA or Dept of Agriculture re PTE application | 06 Feb, 2024 | US10836768 |
| Letter from FDA or Dept of Agriculture re PTE application | 06 Feb, 2024 | US9987274 |
| Letter re PTE application to FDA or Dept of Agriculture | 29 Sep, 2023 | US10836768 |
| Letter re PTE application to FDA or Dept of Agriculture | 29 Sep, 2023 | US9422299 |
FDA has granted several exclusivities to Veozah. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Veozah, 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 Veozah.
Exclusivity Information
Veozah holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Veozah's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 12, 2028 |
US patents provide insights into the exclusivity only within the United States, but Veozah 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 Veozah's family patents as well as insights into ongoing legal events on those patents.
Veozah's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Veozah's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 28, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Veozah Generics:
There are no approved generic versions for Veozah as of now.
About Veozah
Veozah is a drug owned by Astellas Pharma Us Inc. It is used for managing moderate to severe vasomotor symptoms associated with menopause. Veozah uses Fezolinetant as an active ingredient. Veozah was launched by Astellas in 2023.
Approval Date:
Veozah was approved by FDA for market use on 12 May, 2023.
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 Veozah is 12 May, 2023, its NCE-1 date is estimated to be 13 May, 2027.
Active Ingredient:
Veozah uses Fezolinetant as the active ingredient. Check out other Drugs and Companies using Fezolinetant ingredient
Treatment:
Veozah is used for managing moderate to severe vasomotor symptoms associated with menopause.
Dosage:
Veozah is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 45MG | TABLET | Prescription | ORAL |