Byfavo is a drug owned by Acacia Pharma Ltd. It is protected by 11 US drug patents filed from 2021 to 2022 out of which none have expired yet. Byfavo's patents have been open to challenges since 06 October, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 13, 2034. Details of Byfavo'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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9827251 | Dosing regimen for sedation with CNS 7056 (remimazolam) |
Jan, 2034
(9 years from now) | Active |
| US9561236 | Dosing regimen for sedation with CNS 7056 (Remimazolam) |
Apr, 2033
(8 years from now) | Active |
| US10052334 | Dosing regimen for sedation with CNS 7056 (remimazolam) |
Nov, 2031
(6 years from now) | Active |
| US10195210 | Dosing regimen for sedation with CNS 7056 (Remimazolam) |
Nov, 2031
(6 years from now) | Active |
| US10342800 | Dosing regimen for sedation with CNS 7056 (Remimazolam) |
Nov, 2031
(6 years from now) | Active |
| US10722522 | Dosing regimen for sedation with CNS 7056 (remimazolam) |
Nov, 2031
(6 years from now) | Active |
| US9737547 | Dosing regimen for sedation with CNS 7056 (Remimazolam) |
Nov, 2031
(6 years from now) | Active |
| US9777007 | Short-acting benzodiazepine salts and their polymorphic forms |
Jul, 2027
(2 years from now) | Active |
| US9914738 | Short-acting benzodiazepine salts and their polymorphic forms |
Jul, 2027
(2 years from now) | Active |
| US10472365 | Short-acting benzodiazepine salts and their polymorphic forms |
Jul, 2027
(2 years from now) | Active |
| US10961250 | Short-acting benzodiazepine salts and their polymorphic forms |
Jul, 2027
(2 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 Byfavo's patents.
Latest Legal Activities on Byfavo's Patents
Given below is the list of recent legal activities going on the following patents of Byfavo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Term Extension Certificate Critical | 21 May, 2024 | US9827251 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 29 Jan, 2024 | US10722522 |
| Notice of Final Determination -Eligible | 20 Dec, 2023 | US9827251 |
| Change in Power of Attorney (May Include Associate POA) Critical | 19 Dec, 2023 | US9777007 |
| Email Notification Critical | 19 Dec, 2023 | US9777007 |
| Change in Power of Attorney (May Include Associate POA) Critical | 18 Dec, 2023 | US9561236 |
| Email Notification Critical | 18 Dec, 2023 | US10961250 |
| Email Notification Critical | 18 Dec, 2023 | US9561236 |
| Change in Power of Attorney (May Include Associate POA) Critical | 18 Dec, 2023 | US10472365 |
| Email Notification Critical | 18 Dec, 2023 | US10472365 |
FDA has granted several exclusivities to Byfavo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Byfavo, 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 Byfavo.
Exclusivity Information
Byfavo holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Byfavo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 06, 2025 |
US patents provide insights into the exclusivity only within the United States, but Byfavo 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 Byfavo's family patents as well as insights into ongoing legal events on those patents.
Byfavo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Byfavo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 13, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Byfavo Generics:
There are no approved generic versions for Byfavo as of now.
About Byfavo
Byfavo is a drug owned by Acacia Pharma Ltd. It is used for procedural sedation in adults undergoing short procedures. Byfavo uses Remimazolam Besylate as an active ingredient. Byfavo was launched by Acacia in 2020.
Approval Date:
Byfavo was approved by FDA for market use on 06 October, 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 Byfavo is 06 October, 2020, its NCE-1 date is estimated to be 06 October, 2024.
Active Ingredient:
Byfavo uses Remimazolam Besylate as the active ingredient. Check out other Drugs and Companies using Remimazolam Besylate ingredient
Treatment:
Byfavo is used for procedural sedation in adults undergoing short procedures.
Dosage:
Byfavo is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |