BYFAVO Drug Patent Profile
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When do Byfavo patents expire, 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 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
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: | 4 |
| Patent Applications: | 37 |
| 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
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
| Sponsor | Phase |
|---|---|
| Wonkwang University Hospital | N/A |
| Samsung Medical Center | N/A |
| Konkuk University Medical Center | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for BYFAVO
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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Dosing regimen for sedation with CNS 7056 (remimazolam)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting BYFAVO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Acacia | BYFAVO | remimazolam besylate | POWDER;INTRAVENOUS | 212295-001 | Oct 6, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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: ⤷ Try a Trial
Austria
Patent: 80532
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0714886
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 57347
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1501019
Estimated Expiration: ⤷ Try a Trial
Patent: 3288834
Estimated Expiration: ⤷ Try a Trial
Patent: 4059071
Estimated Expiration: ⤷ Try a Trial
Patent: 4059072
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 81921
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 81921
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2007009128
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 37739
Estimated Expiration: ⤷ Try a Trial
Patent: 89383
Estimated Expiration: ⤷ Try a Trial
Patent: 02113
Estimated Expiration: ⤷ Try a Trial
Patent: 02114
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 33413
Estimated Expiration: ⤷ Try a Trial
Patent: 85923
Estimated Expiration: ⤷ Try a Trial
Patent: 09542785
Estimated Expiration: ⤷ Try a Trial
Patent: 13049690
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 09000404
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 81921
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 81921
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 70935
Estimated Expiration: ⤷ Try a Trial
Patent: 09104311
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 81921
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 090045233
Estimated Expiration: ⤷ Try a Trial
Patent: 150081370
Estimated Expiration: ⤷ Try a Trial
Patent: 170091770
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 52360
Estimated Expiration: ⤷ Try a Trial
United Kingdom
Patent: 13692
Estimated Expiration: ⤷ Try a Trial
Patent: 13694
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| South Korea | 102059399 | ⤷ Try a Trial | |
| European Patent Office | 3492080 | RÉGIME DE DOSAGE PERMETTANT LA SÉDATION AVEC CNS 7056 (REMIMAZOLAM) (DOSING REGIMEN FOR SEDATION WITH CNS 7056 (REMIMAZOLAM)) | ⤷ Try a Trial |
| 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) | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2012062439 | ⤷ Try a Trial | |
| China | 101501019 | Short-acting benzodiazepine salts and their polymorphic forms | ⤷ Try a Trial |
| Slovenia | 2637662 | ⤷ Try a Trial | |
| Russian Federation | 2009104311 | БЕНЗОДИАЗЕПИНОВЫЕ СОЛИ КРАТКОВРЕМЕННОГО ДЕЙСТВИЯ И ИХ ПОЛИМОРФНЫЕ ФОРМЫ | ⤷ Try a Trial |
| >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.
ISSN: 2162-2639
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