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Last Updated: December 4, 2024

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BYFAVO Drug Patent Profile


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Which patents cover Byfavo, and what generic alternatives are available?

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
Drug patent expirations by year for BYFAVO
Drug Prices for BYFAVO

See drug prices for BYFAVO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BYFAVO
Generic Entry Date for BYFAVO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS

*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

SponsorPhase
University of Alabama at BirminghamPhase 1
University of California, Los AngelesPhase 4
Seoul National University HospitalPhase 2

See all BYFAVO clinical trials

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
>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
Eurasian Patent Organization 201390672 СХЕМА ПРИЕМА CNS 7056 (РЕМИМАЗОЛАМА) ДЛЯ ИНДУЦИРОВАНИЯ СЕДАЦИИ ⤷  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
South Korea 20090045233 SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS ⤷  Sign Up
Poland 2081921 ⤷  Sign Up
European Patent Office 2450039 ⤷  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.