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 six 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
Summary for BAXDELA
International Patents: | 106 |
US Patents: | 13 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 74 |
Patent Applications: | 386 |
Drug Prices: | Drug price information for BAXDELA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for BAXDELA |
What excipients (inactive ingredients) are in BAXDELA? | BAXDELA excipients list |
DailyMed Link: | BAXDELA at DailyMed |


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
Drug Class | Fluoroquinolone Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes 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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Salt and crystalline forms thereof of a drug
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Salt and crystalline forms thereof of a drug
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Salt and crystalline forms thereof of a drug
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Salt and crystalline forms thereof of a drug
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Salt and crystalline forms thereof of a drug
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Process for making quinolone compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting BAXDELA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA (CABP) CAUSED BY DESIGNATED SUSCEPTIBLE BACTERIA IN ADULTS
Exclusivity Expiration: ⤷ Try a Trial
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Melinta | BAXDELA | delafloxacin meglumine | TABLET;ORAL | 208610-001 | Jun 19, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Melinta | BAXDELA | delafloxacin meglumine | TABLET;ORAL | 208610-001 | Jun 19, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Melinta | BAXDELA | delafloxacin meglumine | POWDER;INTRAVENOUS | 208611-001 | Jun 19, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Melinta | BAXDELA | delafloxacin meglumine | POWDER;INTRAVENOUS | 208611-001 | Jun 19, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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: ⤷ Try a Trial
Denmark
Patent: 56492
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 02607
Estimated Expiration: ⤷ Try a Trial
Patent: 56492
Estimated Expiration: ⤷ Try a Trial
Patent: 57632
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 56718
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 94633
Estimated Expiration: ⤷ Try a Trial
Patent: 08515910
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 56492
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 07004111
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 56492
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 56492
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 56492
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 01955
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Spain | 2826273 | ⤷ Try a Trial | |
Denmark | 2346855 | ⤷ Try a Trial | |
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) | ⤷ Try a Trial |
South Korea | 20200106100 | 알킬화된 시클로덱스트린 조성물 및 이의 제조 및 사용 방법 (Alkylated Cyclodextrin Compositions and Processes for Preparing and using the same) | ⤷ Try a Trial |
South Korea | 101633479 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BAXDELA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
3214083 | PA2021002 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DELAFLOKSACINAS ARBA JO DRUSKA AR ESTERIS, ISKAITANT DELAFLOKSACINO MEGLUMINA; REGISTRATION NO/DATE: EU/1/19/1393 20191216 |
3214083 | LUC00196 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DELAFLOXACINE OU UN DE SES SELS OU ESTERS, Y COMPRIS LA MEGLUMINE DE DELAFLOXACINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1393 20191219 |
3214083 | C202130010 | Spain | ⤷ Try a Trial | PRODUCT NAME: DELAFLOXACINO O UNA SAL O ESTER FARMACEUTICAMENTE ACEPTABLE DEL MISMO, INCLUYENDO DELAFLOXACINO MEGLUMINA.; NATIONAL AUTHORISATION NUMBER: EU/1/19/1393; DATE OF AUTHORISATION: 20191219; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1393; DATE OF FIRST AUTHORISATION IN EEA: 20191216 |
3214083 | C20210002 00366 | Estonia | ⤷ Try a Trial | PRODUCT NAME: DELAFLOKSATSIIN;REG NO/DATE: EU/1/19/1393 19.12.2019 |
3214083 | CR 2021 00002 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DELAFLOXACIN ELLER ET SALT ELLER ESTER DERAF, SAERLIGT DELAFLOXACIN MEGLUMIN; REG. NO/DATE: EU/1/19/1393 20191219 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |