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Last Updated: August 15, 2022

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 ten patents protecting this drug.

This drug has fifty-three patent family members in twenty-four countries.

The generic ingredient in BYFAVO is remimazolam besylate. Additional details are available on the remimazolam besylate profile page.

DrugPatentWatch® Generic Entry Outlook for Byfavo

Byfavo will be eligible for patent challenges on October 6, 2024. 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 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:10
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 2
Patent Applications: 8
What excipients (inactive ingredients) are in BYFAVO?BYFAVO excipients list
DailyMed Link:BYFAVO at DailyMed
Drug patent expirations by year for BYFAVO
DrugPatentWatch® Estimated Generic Entry Opportunity 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
Konkuk University Medical CenterPhase 4
Ajou University School of MedicineN/A

See all BYFAVO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BYFAVO

US Patents and Regulatory Information for BYFAVO

BYFAVO is protected by ten US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BYFAVO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dosing regimen for sedation with CNS 7056 (remimazolam)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting BYFAVO

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Acacia BYFAVO remimazolam besylate POWDER;INTRAVENOUS 212295-001 Oct 6, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acacia BYFAVO remimazolam besylate POWDER;INTRAVENOUS 212295-001 Oct 6, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acacia BYFAVO remimazolam besylate POWDER;INTRAVENOUS 212295-001 Oct 6, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acacia BYFAVO remimazolam besylate POWDER;INTRAVENOUS 212295-001 Oct 6, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Acacia BYFAVO remimazolam besylate POWDER;INTRAVENOUS 212295-001 Oct 6, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Austria

Patent: 0532
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0714886
Estimated Expiration: See Plans and Pricing

Canada

Patent: 57347
Estimated Expiration: See Plans and Pricing

China

Patent: 1501019
Estimated Expiration: See Plans and Pricing

Patent: 3288834
Estimated Expiration: See Plans and Pricing

Patent: 4059071
Estimated Expiration: See Plans and Pricing

Patent: 4059072
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 81921
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 81921
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2007009128
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 37739
Estimated Expiration: See Plans and Pricing

Patent: 89383
Estimated Expiration: See Plans and Pricing

Patent: 02113
Estimated Expiration: See Plans and Pricing

Patent: 02114
Estimated Expiration: See Plans and Pricing

Japan

Patent: 33413
Estimated Expiration: See Plans and Pricing

Patent: 85923
Estimated Expiration: See Plans and Pricing

Patent: 09542785
Estimated Expiration: See Plans and Pricing

Patent: 13049690
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 09000404
Estimated Expiration: See Plans and Pricing

Poland

Patent: 81921
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 81921
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 70935
Estimated Expiration: See Plans and Pricing

Patent: 09104311
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 81921
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 090045233
Estimated Expiration: See Plans and Pricing

Patent: 150081370
Estimated Expiration: See Plans and Pricing

Patent: 170091770
Estimated Expiration: See Plans and Pricing

Spain

Patent: 52360
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 13692
Estimated Expiration: See Plans and Pricing

Patent: 13694
Estimated Expiration: See Plans and Pricing

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
Poland 2081921 See Plans and Pricing
South Korea 20170091770 속효형 벤조디아제핀 염 및 이의 중합체 형태 (SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS) See Plans and Pricing
Brazil PI0714886 sais de benzodiazepina de aÇço rÁpida e suas formas polimàrficas See Plans and Pricing
China 104059072 Short-acting Benzodiazepine Salts And Their Polymorphic Forms See Plans and Pricing
Poland 2637662 See Plans and Pricing
Denmark 2081921 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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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.