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Last Updated: April 4, 2020

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BAXDELA Drug Profile


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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 thirteen patents protecting this drug.

This drug has seventy-eight patent family members in seventeen 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.

US ANDA Litigation and Generic Entry Outlook for Baxdela

Baxdela will be eligible for patent challenges on June 19, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 28, 2029. This may change due to patent challenges or generic licensing.

There have been three 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

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Drug patent expirations by year for BAXDELA
Drug Prices for BAXDELA

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Generic Entry Opportunity Date for BAXDELA
Generic Entry Dates for BAXDELA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
POWDER;INTRAVENOUS
Generic Entry Dates for BAXDELA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Litigation for BAXDELA

Identify potential future generic entrants

District Court Litigation
Case NameDate
CyDex Pharmaceuticals, Inc. v. Alembic Global Holding SA2019-05-23
MERCK SHARP & DOHME CORP. v. MYLAN LABORATORIES LIMITED2018-03-29
CyDex Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA, Inc.2017-12-20

See all BAXDELA litigation

Pharmacology for BAXDELA
Synonyms for BAXDELA
1-(6-amino-3,5-difluoro-2-pyridyl)-8-chloro-6-fluoro-7-(3-hydroxyazetidin-1-yl)-4-oxo-quinoline-3-carboxylic acid
1-(6-AMINO-3,5-DIFLUORO(PYRIDIN-2-YL))-8-CHLORO-6-FLUORO-7-(3-HYDROXYAZETIDIN-1-YL)-4-OXO-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID
1-(6-AMINO-3,5-DIFLUOROPYRIDIN-2-YL)-8-CHLORO-6-FLUORO-7-(3-HYDROXYAZETIDIN-1-YL)-4-OXO-1,4-DIHYDROQUINOLINE-3-CARBOXYLIC ACID
1-(6-amino-3,5-difluoropyridine-2-yl)-8-chloro-6-fluoro-7-(3-hydroxyazetidine-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid
189279-58-1
189279-58-1, 339591-82-1 (sodium salt)
3-Quinolinecarboxylic acid, 1-(6-amino-3,5-difluoro-2-pyridinyl)-8-chloro-6-fluoro-1,4-dihydro-7-(3-hydroxy-1-azetidinyl)-4-oxo-
6315412YVF
A-319492
AB0032510
Abt 492
ABT-492
ABT-492(Delafloxacin, RX-3341, WQ-3034)
ABT492
AK232294
AS-75147
C18H12ClF3N4O4
CHEMBL2105637
CS-1478
CTK4E0086
D09330
DB11943
Delafloxacin
Delafloxacin (USAN)
Delafloxacin [USAN:INN]
Delafloxacin, >=98% (HPLC)
DelafloxacinABT-492
Delafloxacinum
DTXSID40172331
DYDCPNMLZGFQTM-UHFFFAOYSA-N
EX-A2331
FT-0697895
HY-14814
KS-00000TIQ
NCGC00390187-01
Q5253067
QCR-52
RX-3341
RX-3341; WQ-3034; ABT492; Delafloxacin
s1553
SB16746
SC-52686
SCHEMBL294694
UNII-6315412YVF
W-5433
WQ 3034
WQ-3034
WQ-3034, ABT492;189279-58-1
X5822
ZINC000003827556
ZINC3827556

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

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Express Scripts
Baxter
Moodys
Merck

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. 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.