Last Updated: September 23, 2026

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 thirteen patents protecting this drug. Additional details are available on the BAXDELA profile page.

The generic ingredient in BAXDELA is delafloxacin meglumine. There is one drug master file entry for this compound. 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:	13

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

Generic Entry Date for 208611^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial 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:	⤷ Start Trial	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	⤷ Start Trial	⤷ Start Trial
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017	⤷ Start Trial	⤷ Start Trial
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.