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Last Updated: May 24, 2024

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BAXDELA Drug Patent 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 one hundred and twelve patent family members in twenty-eight 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

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Drug patent expirations by year for BAXDELA
Drug Prices for BAXDELA

See drug prices for BAXDELA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BAXDELA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Salt and crystalline forms thereof of a drug
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Salt and crystalline forms thereof of a drug
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS

Salt and crystalline forms thereof of a drug
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Salt and crystalline forms thereof of a drug
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS

Process for making quinolone compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Salt and crystalline forms thereof of a drug
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS

Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Salt and crystalline forms thereof of a drug
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS

Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Process for making quinolone compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting BAXDELA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  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 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;INTRAVENOUS 208611-001 Jun 19, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Melinta BAXDELA delafloxacin meglumine POWDER;INTRAVENOUS 208611-001 Jun 19, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Melinta BAXDELA delafloxacin meglumine POWDER;INTRAVENOUS 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

International Patents for BAXDELA

When does loss-of-exclusivity occur for BAXDELA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Patent: 82954
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 25048
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 56492
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 02607
Estimated Expiration: ⤷  Sign Up

Patent: 56492
Estimated Expiration: ⤷  Sign Up

Patent: 57632
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 56718
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 94633
Estimated Expiration: ⤷  Sign Up

Patent: 08515910
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 56492
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 07004111
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 56492
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 56492
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 56492
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 01955
Estimated Expiration: ⤷  Sign Up

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

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

Country Patent Number Title Estimated Expiration
Eurasian Patent Organization 201000828 СОСТАВЫ НА ОСНОВЕ СУЛЬФОАЛКИЛЬНЫХ ЭФИРОВ ЦИКЛОДЕКСТРИНА ⤷  Sign Up
Hungary S2100004 ⤷  Sign Up
European Patent Office 2748205 COMPOSITIONS DE CYCLODEXTRINE ALKYLÉE ET PROCÉDÉS POUR LEUR PRÉPARATION ET LEUR UTILISATION (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME) ⤷  Sign Up
South Korea 101314803 ⤷  Sign Up
Japan 2016166368 アルキル化シクロデキストリン組成物ならびにその調製方法および使用方法 (ALKYLATED CYCLODEXTRIN COMPOSITION AS WELL AS PREPARATION METHOD AND USE METHOD THEREOF) ⤷  Sign Up
Mexico 2014010323 COMPOSICIONES DE CICLODEXTRINA ALQUILADA Y PROCESOS PARA PREPARAR Y UTILIZAR LAS MISMAS. (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BAXDELA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3214083 2190500-5 Sweden ⤷  Sign Up PRODUCT NAME: DELAFLOXACIN IN FREE FORM OR IN PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER FORM, INCLUDING DELAFLOXACIN MEGLUMINE; REG. NO/DATE: EU/1/19/1393 20191219
3214083 PA2021002 Lithuania ⤷  Sign Up PRODUCT NAME: DELAFLOKSACINAS ARBA JO DRUSKA AR ESTERIS, ISKAITANT DELAFLOKSACINO MEGLUMINA; REGISTRATION NO/DATE: EU/1/19/1393 20191216
3214083 C20210002 00366 Estonia ⤷  Sign Up PRODUCT NAME: DELAFLOKSATSIIN;REG NO/DATE: EU/1/19/1393 19.12.2019
3214083 132021000000011 Italy ⤷  Sign Up 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 ⤷  Sign Up 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)
3214083 301091 Netherlands ⤷  Sign Up 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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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.