Brexafemme is a drug owned by Scynexis Inc. It is protected by 5 US drug patents filed from 2021 to 2023 out of which none have expired yet. Brexafemme's patents will be open to challenges from 01 June, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 10, 2039. Details of Brexafemme'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. | |||
| US10927142 | Salts and polymorphs of SCY-078 |
Jan, 2035
(9 years from now) | Active |
| US10174074 | Salts and polymorphs of SCY-078 |
Jan, 2035
(9 years from now) | Active |
| US8188085 | Antifungal agents |
Aug, 2030
(5 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). | |||
| US11534433 | Antifungal agents with enhanced activity in acidic pH |
Jun, 2039
(14 years from now) | Active |
| US10370406 | Salts and polymorphs of SCY-078 |
Jan, 2035
(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 Brexafemme's patents.
Latest Legal Activities on Brexafemme's Patents
Given below is the list of recent legal activities going on the following patents of Brexafemme.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 10 Jul, 2024 | US10927142 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US8188085 |
| transaction for FDA Determination of Regulatory Review Period | 28 Feb, 2024 | US8188085 |
| Second letter to regulating agency to determine regulatory review period | 21 Dec, 2023 | US8188085 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 Nov, 2023 | US8188085 |
| Letter from FDA or Dept of Agriculture re PTE application | 19 Oct, 2023 | US8188085 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Feb, 2023 | US10370406 |
| Recordation of Patent Grant Mailed Critical | 27 Dec, 2022 | US11534433 |
| Patent Issue Date Used in PTA Calculation Critical | 27 Dec, 2022 | US11534433 |
| Issue Notification Mailed Critical | 07 Dec, 2022 | US11534433 |
FDA has granted several exclusivities to Brexafemme. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Brexafemme, 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 Brexafemme.
Exclusivity Information
Brexafemme holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Brexafemme's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-903) | Nov 30, 2025 |
| New Chemical Entity Exclusivity(NCE) | Jun 01, 2026 |
| Generating Antibiotic Incentives Now(GAIN) | Jun 01, 2031 |
Several oppositions have been filed on Brexafemme's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Brexafemme's generic, the next section provides detailed information on ongoing and past EP oppositions related to Brexafemme patents.
Brexafemme's Oppositions Filed in EPO
Brexafemme has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 09, 2022, by Synthon Bv. This opposition was filed on patent number EP16703009A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP16703009A | Dec, 2022 | Synthon BV | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Brexafemme 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 Brexafemme's family patents as well as insights into ongoing legal events on those patents.
Brexafemme's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Brexafemme's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 10, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Brexafemme Generics:
There are no approved generic versions for Brexafemme as of now.
About Brexafemme
Brexafemme is a drug owned by Scynexis Inc. It is used for preventing and treating recurrent and acute vulvovaginal candidiasis in adult and post-menarchal pediatric females. Brexafemme uses Ibrexafungerp Citrate as an active ingredient. Brexafemme was launched by Scynexis in 2021.
Approval Date:
Brexafemme was approved by FDA for market use on 01 June, 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 Brexafemme is 01 June, 2021, its NCE-1 date is estimated to be 01 June, 2030.
Active Ingredient:
Brexafemme uses Ibrexafungerp Citrate as the active ingredient. Check out other Drugs and Companies using Ibrexafungerp Citrate ingredient
Treatment:
Brexafemme is used for preventing and treating recurrent and acute vulvovaginal candidiasis in adult and post-menarchal pediatric females.
Dosage:
Brexafemme is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 150MG BASE | TABLET | Prescription | ORAL |