Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Medtronic
Moodys
Dow
Merck

Last Updated: May 19, 2022

BAXDELA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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 four patent family members in twenty-six 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

< Available with Subscription >

  Try it Free

Drug patent expirations by year for BAXDELA
Drug Prices for BAXDELA

See drug prices for BAXDELA

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

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BAXDELA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Salt and crystalline forms thereof of a drug
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Salt and crystalline forms thereof of a drug
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Salt and crystalline forms thereof of a drug
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Process for making quinolone compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting BAXDELA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA (CABP) CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
Exclusivity Expiration: See Plans and Pricing

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Melinta BAXDELA delafloxacin meglumine TABLET;ORAL 208610-001 Jun 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Melinta BAXDELA delafloxacin meglumine TABLET;ORAL 208610-001 Jun 19, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Denmark

Patent: 56492
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 02607
Estimated Expiration: See Plans and Pricing

Patent: 56492
Estimated Expiration: See Plans and Pricing

Patent: 57632
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 56718
Estimated Expiration: See Plans and Pricing

Japan

Patent: 94633
Estimated Expiration: See Plans and Pricing

Patent: 08515910
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 56492
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07004111
Estimated Expiration: See Plans and Pricing

Poland

Patent: 56492
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 56492
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 56492
Estimated Expiration: See Plans and Pricing

Spain

Patent: 01955
Estimated Expiration: See Plans and Pricing

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
Portugal 3056492 See Plans and Pricing
Hong Kong 1219883 磺烷基醚環糊精組合物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) See Plans and Pricing
European Patent Office 2268269 COMPOSITIONS DE CYCLODEXTRINE À GROUPEMENTS ÉTHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BAXDELA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3214083 132021000000011 Italy See Plans and Pricing 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 PA2021002 Lithuania See Plans and Pricing PRODUCT NAME: DELAFLOKSACINAS ARBA JO DRUSKA AR ESTERIS, ISKAITANT DELAFLOKSACINO MEGLUMINA; REGISTRATION NO/DATE: EU/1/19/1393 20191216
3214083 122021000010 Germany See Plans and Pricing PRODUCT NAME: DELAFLOXACIN ODER EIN SALZ ODER ESTER DAVON, EINSCHLIESSLICH DELAFLOXACINMEGLUMIN.; REGISTRATION NO/DATE: EU/1/19/1393 20191216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.