DELAFLOXACIN MEGLUMINE - Generic Drug Details

What are the generic drug sources for delafloxacin meglumine and what is the scope of freedom to operate?

Delafloxacin meglumine is the generic ingredient in one branded drug marketed by Melinta and is included in two NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Delafloxacin meglumine has one hundred and twenty-nine patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for DELAFLOXACIN MEGLUMINE

International Patents:	129
US Patents:	14
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	41
Patent Applications:	27
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DELAFLOXACIN MEGLUMINE
What excipients (inactive ingredients) are in DELAFLOXACIN MEGLUMINE?	DELAFLOXACIN MEGLUMINE excipients list
DailyMed Link:	DELAFLOXACIN MEGLUMINE at DailyMed

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

Dosage:

POWDER;INTRAVENOUS

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 DELAFLOXACIN MEGLUMINE

Drug Class

Fluoroquinolone Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for DELAFLOXACIN MEGLUMINE

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for DELAFLOXACIN MEGLUMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes				Y
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017		RX	Yes	Yes			Y
Melinta	BAXDELA	delafloxacin meglumine	TABLET;ORAL	208610-001	Jun 19, 2017		RX	Yes	Yes			Y
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes

International Patents for DELAFLOXACIN MEGLUMINE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2748205	COMPOSITIONS DE CYCLODEXTRINE ALKYLÉE ET PROCÉDÉS POUR LEUR PRÉPARATION ET LEUR UTILISATION (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME)
South Korea	20200106100	알킬화된 시클로덱스트린 조성물 및 이의 제조 및 사용 방법 (Alkylated Cyclodextrin Compositions and Processes for Preparing and using the same)
Croatia	P20201879
South Korea	20160116020	퀴놀론 화합물의 제조 방법 (PROCESS FOR MAKING QUINOLONE COMPOUNDS)

Supplementary Protection Certificates for DELAFLOXACIN MEGLUMINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3214083	21C1006	France		PRODUCT NAME: DELAFLOXACINE; REGISTRATION NO/DATE: EU/1/19/1393 20191219
3214083	SPC/GB20/073	United Kingdom		PRODUCT NAME: DELAFLOXACIN OR A SALT OR ESTER THEREOF, INCLUDING DELAFLOXACIN MEGLUMINE; REGISTERED: UK EU/1/19/1393 20191219; UK PLGB 10649/0009(NI) 20191219; UK PLGB 10649/0010(NI) 20191219
3214083	LUC00196	Luxembourg		PRODUCT NAME: DELAFLOXACINE OU UN DE SES SELS OU ESTERS, Y COMPRIS LA MEGLUMINE DE DELAFLOXACINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1393 20191219
3214083	2021/002	Ireland		PRODUCT NAME: DELAFLOXACIN OR A SALT OR ESTER THEREOF, INCLUDING DELAFLOXACIN MEGLUMINE; NAT REGISTRATION NO/DATE: EU/1/19/1393 20191216; FIRST REGISTRATION NO/DATE: EU/1/19/1393 16/12/2019 (12/10/2022) JOURNAL OF THE INTELLECTUAL PROPERTY OFFICE OF IRELAND (NO. 2474)