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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
Chinese Patent Office
Cantor Fitzgerald
Citi
Express Scripts
Federal Trade Commission
Farmers Insurance
US Department of Justice

Generated: July 17, 2018

DrugPatentWatch Database Preview

BAXDELA Drug Profile

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Which patents cover Baxdela, 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 sixty-seven 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.
Summary for BAXDELA
Drug patent expirations by year for BAXDELA
Generic Entry Opportunity Date for BAXDELA
Generic Entry Dates for BAXDELA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
POWDER;IV (INFUSION)
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.

Synonyms for BAXDELA
(2R,3R,4R,5S)-2,3,4,5-Tetrahydroxy-6-(methylamino)hexyl 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-7-(3-hydroxyazetidin-1-yl)-4-oxo-1,4-dihydroquin
1-Deoxy-1-(methylamino)-D-glucitol 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-7-(3-hydroxyazetidin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylate (salt)
352458-37-8
AK174868
AKOS025404885
CHEMBL2105638
D-Glucitol, 1-deoxy-1-(methylamino)-, 1-(6-amino-3,5-difluoro-2-pyridinyl)-8-chloro-6-fluoro-1,4-dihydro-7-(3-hydroxy-1-azetidinyl)-4-oxo-3-quinolinecarboxylate (salt)
D04XDT
D09331
Delafloxacin (meglumine)
Delafloxacin meglumine
Delafloxacin meglumine (USAN)
Delafloxacin meglumine [USAN]
Delafloxacin-meglumine
DTXSID90188740
N7V53U4U4T
QC-11727
SCHEMBL300983
UNII-N7V53U4U4T
W-6128
WQ-3034 AND ABT-492

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;IV (INFUSION) 208611-001 Jun 19, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Melinta BAXDELA delafloxacin meglumine TABLET;ORAL 208610-001 Jun 19, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Melinta BAXDELA delafloxacin meglumine TABLET;ORAL 208610-001 Jun 19, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Melinta BAXDELA delafloxacin meglumine POWDER;IV (INFUSION) 208611-001 Jun 19, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Non-Orange Book US Patents for BAXDELA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,497,378 Process for making quinolone compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
US Department of Justice
Argus Health
Baxter
AstraZeneca
Fuji
Fish and Richardson
Harvard Business School
Federal Trade Commission

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 verifification 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.