BRENZAVVY Drug Patent Profile

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Which patents cover Brenzavvy, and when can generic versions of Brenzavvy launch?

Brenzavvy is a drug marketed by Theracosbio and is included in one NDA. There are seven patents protecting this drug.

The generic ingredient in BRENZAVVY is bexagliflozin. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the bexagliflozin profile page.

DrugPatentWatch^® Generic Entry Outlook for Brenzavvy

Brenzavvy will be eligible for patent challenges on January 20, 2027. 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 October 5, 2041. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BRENZAVVY

US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	37
Patent Applications:	236
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BRENZAVVY
What excipients (inactive ingredients) are in BRENZAVVY?	BRENZAVVY excipients list
DailyMed Link:	BRENZAVVY at DailyMed

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

NDA:

214373

Dosage:

TABLET;ORAL

^*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.

Pharmacology for BRENZAVVY

Drug Class	Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Sodium-Glucose Transporter 2 Inhibitors

US Patents and Regulatory Information for BRENZAVVY

BRENZAVVY is protected by seven 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.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Theracosbio	BRENZAVVY	bexagliflozin	TABLET;ORAL	214373-001	Jan 20, 2023		RX	Yes	Yes
Theracosbio	BRENZAVVY	bexagliflozin	TABLET;ORAL	214373-001	Jan 20, 2023		RX	Yes	Yes			Y	Y
Theracosbio	BRENZAVVY	bexagliflozin	TABLET;ORAL	214373-001	Jan 20, 2023		RX	Yes	Yes			Y	Y

International Patents for BRENZAVVY

When does loss-of-exclusivity occur for BRENZAVVY?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Canada

China

European Patent Office

Israel

Japan

Mexico

South Korea

Taiwan

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 BRENZAVVY around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	121997
Australia	2011264220
Brazil	112012031616