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BAXDELA Drug Patent Profile

When do Baxdela patents expire, and when can generic versions of Baxdela launch?

Baxdela is a drug marketed by Melinta and is included in two NDAs. There are fourteen patents protecting this drug.

This drug has one hundred and twenty-nine patent family members in thirty-one countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Baxdela

Baxdela was eligible for patent challenges on June 19, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 19, 2031. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for BAXDELA

International Patents:	129
US Patents:	14
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	77
Patent Applications:	248
Drug Prices:	Drug price information for BAXDELA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BAXDELA
What excipients (inactive ingredients) are in BAXDELA?	BAXDELA excipients list
DailyMed Link:	BAXDELA at DailyMed

See drug prices for BAXDELA

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

NDA:

208611

Dosage:

POWDER;INTRAVENOUS

NDA:

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 BAXDELA

Drug Class

Fluoroquinolone Antibacterial

US Patents and Regulatory Information for BAXDELA

BAXDELA is protected by fourteen US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting BAXDELA

FDA Regulatory Exclusivity protecting BAXDELA

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
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
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

International Patents for BAXDELA

See the table below for patents covering BAXDELA around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	S2100004
Lithuania	3766876
Serbia	61194	POSTUPAK ZA PRAVLJENJE HINOLONSKIH JEDINJENJA (PROCESS FOR MAKING QUINOLONE COMPOUNDS)
Hong Kong	1244481	製備喹諾酮化合物的方法 (PROCESS FOR MAKING QUINOLONE COMPOUNDS)
Japan	2017019879	スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)
Hong Kong	1211311	烷基化環糊精組合物及其製備和使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME)
Japan	2015110671	スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)

Supplementary Protection Certificates for BAXDELA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3214083	C03214083/01	Switzerland		PRODUCT NAME: DELAFLOXACIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67238 28.05.2020
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
3214083	2021C/504	Belgium		PRODUCT NAME: DELAFLOXACINE OU UN SEL OU ESTER DE CELLE-CI, Y COMPRIS LA DELAFLOXACINE MEGLUMINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1393 20191219
3214083	5/2021	Austria		PRODUCT NAME: DELAFLOXACIN ODER EIN SALZ ODER ESTER DAVON, EINSCHLIESSLICH DELAFLOXACIN-MEGLUMIN; REGISTRATION NO/DATE: EU/1/19/1393 (MITTEILUNG) 20191219
3214083	122021000010	Germany		PRODUCT NAME: DELAFLOXACIN ODER EIN SALZ ODER ESTER DAVON, EINSCHLIESSLICH DELAFLOXACINMEGLUMIN.; REGISTRATION NO/DATE: EU/1/19/1393 20191216
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	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)