BYFAVO Drug Patent Profile

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-four 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:	54
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

See drug prices for BYFAVO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BYFAVO

NDA:

212295

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

See all BYFAVO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BYFAVO

N05CD	Benzodiazepine derivatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for BYFAVO

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

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

FDA Regulatory Exclusivity protecting BYFAVO

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			Y
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes
Acacia	BYFAVO	remimazolam besylate	POWDER;INTRAVENOUS	212295-001	Oct 6, 2020		RX	Yes	Yes

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

Austria

Brazil

Canada

China

Denmark

European Patent Office

Germany

Hong Kong

Japan

Mexico

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

United Kingdom

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
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)
South Korea	20090045233	SHORT-ACTING BENZODIAZEPINE SALTS AND THEIR POLYMORPHIC FORMS
Poland	2081921
European Patent Office	2450039	Régime de dosage permettant la sédation avec CNS 7056 (Remimazolam) (Dosing regimen for sedation with CNS 7056 (Remimazolam))
Portugal	2637662