Barhemsys is a drug owned by Acacia Pharma Ltd. It is protected by 5 US drug patents filed from 2020 to 2022 out of which none have expired yet. Barhemsys's patents have been open to challenges since 27 February, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 09, 2038. Details of Barhemsys's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9545426 | Use of amisulpride as an anti-emetic |
Mar, 2031
(6 years from now) | Active |
| US9889118 | Use of amisulpride as an anti-emetic |
Mar, 2031
(6 years from now) | Active |
| US10525033 | Use of amisulpride as an anti-emetic |
Mar, 2031
(6 years from now) | Active |
| US9084765 | Use of amisulpride as an anti-emetic |
Feb, 2034
(9 years from now) | Active |
| US11357753 | Rescue treatment of post operative nausea and vomiting |
Feb, 2038
(13 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 Barhemsys's patents.
Latest Legal Activities on Barhemsys's Patents
Given below is the list of recent legal activities going on the following patents of Barhemsys.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) Critical | 12 Oct, 2023 | US11357753 |
| Email Notification Critical | 12 Oct, 2023 | US11357753 |
| Change in Power of Attorney (May Include Associate POA) Critical | 11 Oct, 2023 | US9889118 |
| Change in Power of Attorney (May Include Associate POA) Critical | 11 Oct, 2023 | US9545426 |
| Email Notification Critical | 11 Oct, 2023 | US10525033 |
| Email Notification Critical | 11 Oct, 2023 | US9084765 |
| Change in Power of Attorney (May Include Associate POA) Critical | 11 Oct, 2023 | US9084765 |
| Change in Power of Attorney (May Include Associate POA) Critical | 11 Oct, 2023 | US10525033 |
| Email Notification Critical | 11 Oct, 2023 | US9545426 |
| Email Notification Critical | 11 Oct, 2023 | US9889118 |
FDA has granted several exclusivities to Barhemsys. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Barhemsys, 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 Barhemsys.
Exclusivity Information
Barhemsys holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Barhemsys's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 26, 2025 |
US patents provide insights into the exclusivity only within the United States, but Barhemsys 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 Barhemsys's family patents as well as insights into ongoing legal events on those patents.
Barhemsys's Family Patents
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Generic Launch
Generic Release Date:
Barhemsys's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 09, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Barhemsys Generics:
There are no approved generic versions for Barhemsys as of now.
About Barhemsys
Barhemsys is a drug owned by Acacia Pharma Ltd. It is used for prevention and treatment of post-operative nausea and vomiting. Barhemsys uses Amisulpride as an active ingredient. Barhemsys was launched by Acacia in 2020.
Approval Date:
Barhemsys was approved by FDA for market use on 26 February, 2020.
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 Barhemsys is 26 February, 2020, its NCE-1 date is estimated to be 27 February, 2024.
Active Ingredient:
Barhemsys uses Amisulpride as the active ingredient. Check out other Drugs and Companies using Amisulpride ingredient
Treatment:
Barhemsys is used for prevention and treatment of post-operative nausea and vomiting.
Dosage:
Barhemsys is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG/2ML (2.5MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 10MG/4ML (2.5MG/ML) | SOLUTION | Prescription | INTRAVENOUS |