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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Delafloxacin meglumine has one hundred and ten patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for DELAFLOXACIN MEGLUMINE

International Patents:	110
US Patents:	13
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

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
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
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes			Y
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes				Y
Melinta	BAXDELA	delafloxacin meglumine	POWDER;INTRAVENOUS	208611-001	Jun 19, 2017		RX	Yes	Yes			Y

International Patents for DELAFLOXACIN MEGLUMINE

Country	Patent Number	Title	Estimated Expiration
Finland	3766876
China	114053423	磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions)
World Intellectual Property Organization (WIPO)	2013130666
Lithuania	PA2021002
Japan	2016166368	アルキル化シクロデキストリン組成物ならびにその調製方法および使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITION AS WELL AS PREPARATION METHOD AND USE METHOD THEREOF)
South Korea	101775304
Portugal	3214083

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	PA2021002	Lithuania		PRODUCT NAME: DELAFLOKSACINAS ARBA JO DRUSKA AR ESTERIS, ISKAITANT DELAFLOKSACINO MEGLUMINA; REGISTRATION NO/DATE: EU/1/19/1393 20191216
3214083	CR 2021 00002	Denmark		PRODUCT NAME: DELAFLOXACIN ELLER ET SALT ELLER ESTER DERAF, SAERLIGT DELAFLOXACIN MEGLUMIN; REG. NO/DATE: EU/1/19/1393 20191219
3214083	301091	Netherlands		PRODUCT NAME: DELAFLOXACINE, OF EEN ZOUT OF ESTERS ERVAN, MET INBEGRIP VAN DELAFLOXACINE MEGLUMINE; 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	132021000000011	Italy		PRODUCT NAME: DELAFLOXACINA O UN SUO SALE O ESTERE, INCLUSA LA DELAFLOXACINA MEGLUMINA(QUOFENIX); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1393, 20191219
3214083	C202130010	Spain		PRODUCT NAME: DELAFLOXACINO O UNA SAL O ESTER FARMACEUTICAMENTE ACEPTABLE DEL MISMO, INCLUYENDO DELAFLOXACINO MEGLUMINA.; NATIONAL AUTHORISATION NUMBER: EU/1/19/1393; DATE OF AUTHORISATION: 20191219; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1393; DATE OF FIRST AUTHORISATION IN EEA: 20191216