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Last Updated: August 15, 2020

DrugPatentWatch Database Preview

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-nine 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 five 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
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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.

Pharmacology for BAXDELA

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
>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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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.