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Last Updated: May 11, 2021

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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 ninety patent family members in twenty-four 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 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 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

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Drug patent expirations by year for BAXDELA
Drug Prices for BAXDELA

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DrugPatentWatch® Estimated 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   Get Started for $10   Get Started for $10 Y   Get Started for $10
Melinta BAXDELA delafloxacin meglumine TABLET;ORAL 208610-001 Jun 19, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Melinta BAXDELA delafloxacin meglumine TABLET;ORAL 208610-001 Jun 19, 2017 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Melinta BAXDELA delafloxacin meglumine POWDER;INTRAVENOUS 208611-001 Jun 19, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Melinta BAXDELA delafloxacin meglumine POWDER;INTRAVENOUS 208611-001 Jun 19, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for BAXDELA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3214083 301091 Netherlands   Get Started for $10 PRODUCT NAME: DELAFLOXACINE, OF EEN ZOUT OF ESTERS ERVAN, MET INBEGRIP VAN DELAFLOXACINE MEGLUMINE; REGISTRATION NO/DATE: EU/1/19/1393 20191219
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
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Merck

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