Details for New Drug Application (NDA): 208610

NDA 208610 describes BAXDELA, which is a drug marketed by Melinta and is included in two NDAs. It is available from one supplier. There are fourteen 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 208610

Tradename:	BAXDELA
Applicant:	Melinta
Ingredient:	delafloxacin meglumine
Patents:	8

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208610

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: 208610

Suppliers and Packaging for NDA: 208610

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610	NDA	Melinta Therapeutics, LLC	70842-101	70842-101-01	1 BOTTLE in 1 CARTON (70842-101-01) / 20 TABLET in 1 BOTTLE
BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610	NDA	Melinta Therapeutics, LLC	70842-101	70842-101-02	2 BLISTER PACK in 1 CARTON (70842-101-02) / 10 TABLET in 1 BLISTER PACK (70842-101-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 450MG BASE
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:		Patent Expiration:	Jun 19, 2031	Product Flag?		Substance Flag?	Y	Delist Request?

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