BREXAFEMME Drug Patent Profile
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When do Brexafemme patents expire, and what generic alternatives are available?
Brexafemme is a drug marketed by Scynexis and is included in one NDA. There are five patents protecting this drug.
This drug has fifty patent family members in twenty-four countries.
The generic ingredient in BREXAFEMME is ibrexafungerp citrate. One supplier is listed for this compound. Additional details are available on the ibrexafungerp citrate profile page.
DrugPatentWatch® Generic Entry Outlook for Brexafemme
Brexafemme will be eligible for patent challenges on June 1, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 19, 2035. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for BREXAFEMME
| International Patents: | 50 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 11 |
| Drug Prices: | Drug price information for BREXAFEMME |
| What excipients (inactive ingredients) are in BREXAFEMME? | BREXAFEMME excipients list |
| DailyMed Link: | BREXAFEMME at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BREXAFEMME
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for BREXAFEMME
| Drug Class | Triterpenoid Antifungal |
| Mechanism of Action | Glucan Synthase Inhibitors |
US Patents and Regulatory Information for BREXAFEMME
BREXAFEMME is protected by six US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BREXAFEMME is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting BREXAFEMME
Salts and polymorphs of SCY-078
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Salts and polymorphs of SCY-078
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT AND POST-MENARCHAL PEDIATRIC FEMALES WITH VULVOVAGINAL CANDIDIASIS (VVC)
Salts and polymorphs of SCY-078
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT AND POST-MENARCHAL PEDIATRIC FEMALES WITH VULVOVAGINAL CANDIDIASIS (VVC)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: REDUCTION IN THE INCIDENCE OF RECURRENT VULVOVAGINAL CANDIDIASIS (RVVC) IN ADULT AND POST-MENARCHAL PEDIATRIC FEMALES
Antifungal agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT AND POST-MENARCHAL PEDIATRIC FEMALES WITH VULVOVAGINAL CANDIDIASIS (VVC)
FDA Regulatory Exclusivity protecting BREXAFEMME
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
REDUCTION IN THE INCIDENCE OF RECURRENT VULVOVAGINAL CANDIDIASIS (RVVC) IN ADULT AND POST-MENARCHAL PEDIATRIC FEMALES
Exclusivity Expiration: ⤷ Sign Up
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Scynexis | BREXAFEMME | ibrexafungerp citrate | TABLET;ORAL | 214900-001 | Jun 1, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Scynexis | BREXAFEMME | ibrexafungerp citrate | TABLET;ORAL | 214900-001 | Jun 1, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Scynexis | BREXAFEMME | ibrexafungerp citrate | TABLET;ORAL | 214900-001 | Jun 1, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Scynexis | BREXAFEMME | ibrexafungerp citrate | TABLET;ORAL | 214900-001 | Jun 1, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Scynexis | BREXAFEMME | ibrexafungerp citrate | TABLET;ORAL | 214900-001 | Jun 1, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Scynexis | BREXAFEMME | ibrexafungerp citrate | TABLET;ORAL | 214900-001 | Jun 1, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for BREXAFEMME
When does loss-of-exclusivity occur for BREXAFEMME?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Croatia
Patent: 0220544
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 47711
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 6874
Patent: НОВЫЕ СОЛИ И ПОЛИМОРФЫ SCY-078 (NOVEL SALTS AND POLYMORPHS OF SCY-078)
Estimated Expiration: ⤷ Sign Up
Patent: 1791645
Patent: НОВЫЕ СОЛИ И ПОЛИМОРФЫ SCY-078
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 47711
Patent: NOUVEAUX SELS ET POLYMORPHES DE SCY-078 (NOVEL SALTS AND POLYMORPHS OF SCY-078)
Estimated Expiration: ⤷ Sign Up
Patent: 39684
Patent: NOUVEAUX SELS ET POLYMORPHES DE SCY-078 (NOVEL SALTS AND POLYMORPHS OF SCY-078)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 47196
Patent: SCY-078的新型鹽及多晶型物 (NOVEL SALTS AND POLYMORPHS OF SCY-078)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 58721
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 47711
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 47711
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 47711
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 234
Patent: NOVE SOLI I POLIMORFI SCY-078 (NOVEL SALTS AND POLYMORPHS OF SCY-078)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 47711
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 13111
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering BREXAFEMME around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| China | 104877001 | Antifungal Agents | ⤷ Sign Up |
| Japan | 7214714 | ⤷ Sign Up | |
| Moldova, Republic of | 3661503 | ⤷ Sign Up | |
| Morocco | 49751 | AGENTS ANTIFONGIQUES À ACTIVITÉ AMÉLIORÉE EN PH ACIDE | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2016118396 | ⤷ Sign Up | |
| Canada | 2731941 | AGENTS ANTIFONGIQUES (ANTIFUNGAL AGENTS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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