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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208611

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NDA 208611 describes BAXDELA, which is a drug marketed by Melinta and is included in two NDAs. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the BAXDELA profile page.

The generic ingredient in BAXDELA is delafloxacin meglumine. One supplier is listed for this compound. Additional details are available on the delafloxacin meglumine profile page.

Summary for 208611

Tradename:	BAXDELA
Applicant:	Melinta
Ingredient:	delafloxacin meglumine
Patents:	14

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208611

Generic Entry Date for 208611^: ⤷ Get Started Free* Constraining patent/regulatory exclusivity: 7,728,143 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.

Pharmacology for NDA: 208611

Suppliers and Packaging for NDA: 208611

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611	NDA	Melinta Therapeutics, LLC	70842-102	70842-102-03	10 VIAL, GLASS in 1 CARTON (70842-102-03) / 10.5 mL in 1 VIAL, GLASS (70842-102-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 300MG BASE/VIAL
Approval Date:	Jun 19, 2017	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 19, 2027
Regulatory Exclusivity Use:	GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:	Jun 19, 2022
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	12,036,219	Patent Expiration:	Jun 2, 2034	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATING AN ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTION (ABSSSI) IN AN OVERWEIGHT OR OBESE PATIENT BY INTRAVENOUSLY (IV) ADMINISTERING 300MG OF DELAFLOXACIN OR A PHARMACEUTICALLY ACCEPTABLE SALT, TWICE A DAY

Expired US Patents for NDA 208611

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017	8,648,093	⤷ Get Started Free
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017	9,539,250	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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