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Last Updated: July 13, 2024

Details for New Drug Application (NDA): 214373


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NDA 214373 describes BRENZAVVY, which is a drug marketed by Theracosbio and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the BRENZAVVY profile page.

The generic ingredient in BRENZAVVY is bexagliflozin. Two suppliers are listed for this compound. Additional details are available on the bexagliflozin profile page.
Summary for 214373
Tradename:BRENZAVVY
Applicant:Theracosbio
Ingredient:bexagliflozin
Patents:6
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214373
Generic Entry Date for 214373*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
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 NDA: 214373
Suppliers and Packaging for NDA: 214373
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRENZAVVY bexagliflozin TABLET;ORAL 214373 NDA AUTHORIZED GENERIC Golden State Medical Supply, Inc. 51407-918 51407-918-30 30 TABLET in 1 BOTTLE (51407-918-30)
BRENZAVVY bexagliflozin TABLET;ORAL 214373 NDA AUTHORIZED GENERIC Golden State Medical Supply, Inc. 51407-918 51407-918-90 90 TABLET in 1 BOTTLE (51407-918-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jan 20, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 20, 2028
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Jul 3, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
Patent:⤷  Sign UpPatent Expiration:Jun 13, 2031Product Flag?YSubstance Flag?YDelist Request?

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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.