BYFAVO Drug Patent Profile
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When do Byfavo patents expire, and when can generic versions of Byfavo launch?
Byfavo is a drug marketed by Acacia and is included in one NDA. There are eleven patents protecting this drug.
This drug has fifty-three patent family members in twenty-four countries.
The generic ingredient in BYFAVO is remimazolam besylate. One supplier is listed for this compound. Additional details are available on the remimazolam besylate profile page.
DrugPatentWatch® Generic Entry Outlook for Byfavo
Byfavo was eligible for patent challenges on October 6, 2024.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 10, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for BYFAVO
| International Patents: | 53 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 50 |
| Clinical Trials: | 8 |
| Patent Applications: | 32 |
| Drug Prices: | Drug price information for BYFAVO |
| What excipients (inactive ingredients) are in BYFAVO? | BYFAVO excipients list |
| DailyMed Link: | BYFAVO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BYFAVO
*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.
Recent Clinical Trials for BYFAVO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alabama at Birmingham | Phase 1 |
| University of California, Los Angeles | Phase 4 |
| Seoul National University Hospital | Phase 2 |
US Patents and Regulatory Information for BYFAVO
BYFAVO is protected by eleven US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BYFAVO 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 BYFAVO
Dosing regimen for sedation with CNS 7056 (remimazolam)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
Dosing regimen for sedation with CNS 7056 (Remimazolam)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
Short-acting benzodiazepine salts and their polymorphic forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
Dosing regimen for sedation with CNS 7056 (remimazolam)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
Short-acting benzodiazepine salts and their polymorphic forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
Dosing regimen for sedation with CNS 7056 (Remimazolam)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
Short-acting benzodiazepine salts and their polymorphic forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Dosing regimen for sedation with CNS 7056 (remimazolam)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
Short-acting benzodiazepine salts and their polymorphic forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting BYFAVO
NEW CHEMICAL ENTITY
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 BYFAVO
When does loss-of-exclusivity occur for BYFAVO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 07274054
Patent: Short-acting benzodiazepine salts and their polymorphic forms
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 80532
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0714886
Patent: sais de benzodiazepina de aÇço rÁpida e suas formas polimàrficas
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 57347
Patent: SELS DE BENZODIAZEPINE ET LEURS FORMES POLYMORPHES A ACTION BREVE (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1501019
Patent: Short-acting benzodiazepine salts and their polymorphic forms
Estimated Expiration: ⤷ Sign Up
Patent: 3288834
Patent: Short-acting benzodiazepine salts and their polymorphic forms
Estimated Expiration: ⤷ Sign Up
Patent: 4059071
Patent: Short-acting Benzodiazepine Salts And Their Polymorphic Forms
Estimated Expiration: ⤷ Sign Up
Patent: 4059072
Patent: Short-acting Benzodiazepine Salts And Their Polymorphic Forms
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 81921
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 81921
Patent: SELS DE BENZODIAZÉPINE ET LEURS FORMES POLYMORPHES À ACTION BRÈVE (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS)
Estimated Expiration: ⤷ Sign Up
Germany
Patent: 2007009128
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 37739
Patent: 短效苯並二氮雜噁鹽及其多晶型 (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS)
Estimated Expiration: ⤷ Sign Up
Patent: 89383
Patent: 短效苯並二氮雜䓬鹽及其多晶型 (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS)
Estimated Expiration: ⤷ Sign Up
Patent: 02113
Patent: 短效苯並二氮雜䓬鹽及其多晶型 (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS)
Estimated Expiration: ⤷ Sign Up
Patent: 02114
Patent: 短效苯並二氮雜䓬鹽及其多晶型 (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 33413
Estimated Expiration: ⤷ Sign Up
Patent: 85923
Estimated Expiration: ⤷ Sign Up
Patent: 09542785
Estimated Expiration: ⤷ Sign Up
Patent: 13049690
Patent: SALT OF SHORT-ACTING BENZODIAZEPINE AND POLYMORPHIC FORM THEREOF
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 09000404
Patent: SALES DE BENZODIAZEPINA DE ACCION CORTA Y SUS FORMAS POLIMORFICAS. (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS.)
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 81921
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 81921
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 70935
Patent: БЕНЗОДИАЗЕПИНОВЫЕ СОЛИ КРАТКОВРЕМЕННОГО ДЕЙСТВИЯ И ИХ ПОЛИМОРФНЫЕ ФОРМЫ (SHORT-TERM ACTION BENZODIAZEPINE SALTS AND POLYMORPHS THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 09104311
Patent: БЕНЗОДИАЗЕПИНОВЫЕ СОЛИ КРАТКОВРЕМЕННОГО ДЕЙСТВИЯ И ИХ ПОЛИМОРФНЫЕ ФОРМЫ
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 81921
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 090045233
Patent: SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS
Estimated Expiration: ⤷ Sign Up
Patent: 150081370
Patent: 속효형 벤조디아제핀 염 및 이의 중합체 형태 (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS)
Estimated Expiration: ⤷ Sign Up
Patent: 170091770
Patent: 속효형 벤조디아제핀 염 및 이의 중합체 형태 (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 52360
Estimated Expiration: ⤷ Sign Up
United Kingdom
Patent: 13692
Estimated Expiration: ⤷ Sign Up
Patent: 13694
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 BYFAVO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Spain | 2352360 | ⤷ Sign Up | |
| Japan | 6084571 | ⤷ Sign Up | |
| Poland | 2637662 | ⤷ Sign Up | |
| South Korea | 20170091770 | 속효형 벤조디아제핀 염 및 이의 중합체 형태 (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS) | ⤷ Sign Up |
| Japan | 2013541567 | ⤷ Sign Up | |
| European Patent Office | 2081921 | SELS DE BENZODIAZÉPINE ET LEURS FORMES POLYMORPHES À ACTION BRÈVE (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS) | ⤷ Sign Up |
| Hong Kong | 1137739 | 短效苯並二氮雜噁鹽及其多晶型 (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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