BAXDELA Drug Patent Profile
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When do Baxdela patents expire, and what generic alternatives are available?
Baxdela is a drug marketed by Melinta and is included in two NDAs. There are fourteen patents protecting this drug.
This drug has one hundred and twenty-nine patent family members in thirty-one 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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Summary for BAXDELA
| International Patents: | 129 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 77 |
| Patent Applications: | 248 |
| 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
*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 |
US Patents and Regulatory Information for BAXDELA
BAXDELA is protected by fourteen 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
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATING AN ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTION (ABSSSI) IN AN OVERWEIGHT OR OBESE PATIENT BY INTRAVENOUSLY (IV) ADMINISTERING 300MG OF DELAFLOXACIN OR A PHARMACEUTICALLY ACCEPTABLE SALT, TWICE A DAY
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 | ⤷ 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 | ⤷ 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 | TABLET;ORAL | 208610-001 | 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
See the table below for patents covering BAXDELA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 6517725 | ⤷ Sign Up | |
| Poland | 3766876 | ⤷ Sign Up | |
| Hong Kong | 1219690 | 利用抗生素來治療超重和肥胖患者感染的方法 (METHODS OF TREATING INFECTIONS IN OVERWEIGHT AND OBESE PATIENTS USING ANTIBIOTICS) | ⤷ Sign Up |
| Japan | 6039721 | ⤷ Sign Up | |
| Israel | 208956 | תכשירי סולפואלקיל אתר ציקלודקסטרין (Sulfoalkyl ether cyclodextrin compositions) | ⤷ Sign Up |
| Lithuania | 3056492 | ⤷ Sign Up | |
| Hungary | S2100004 | ⤷ 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 | 21C1006 | France | ⤷ Sign Up | PRODUCT NAME: DELAFLOXACINE; REGISTRATION NO/DATE: EU/1/19/1393 20191219 |
| 3214083 | SPC/GB20/073 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: DELAFLOXACIN OR A SALT OR ESTER THEREOF, INCLUDING DELAFLOXACIN MEGLUMINE; REGISTERED: UK EU/1/19/1393 20191219; UK PLGB 10649/0009(NI) 20191219; UK PLGB 10649/0010(NI) 20191219 |
| 3214083 | LUC00196 | Luxembourg | ⤷ Sign Up | 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 | 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 | 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 | C202130010 | Spain | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: DELAFLOKSATSIIN;REG NO/DATE: EU/1/19/1393 19.12.2019 |
| >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.
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