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 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
Summary for BAXDELA
| International Patents: | 112 |
| US Patents: | 13 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes 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 | |||
| 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
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 |
|---|---|---|---|
| Australia | 2009297085 | Process for making quinolone compounds | ⤷ Sign Up |
| South Korea | 20160116020 | 퀴놀론 화합물의 제조 방법 (PROCESS FOR MAKING QUINOLONE COMPOUNDS) | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2006042034 | ⤷ Sign Up | |
| China | 105001207 | Process for preparing quinolone compounds | ⤷ Sign Up |
| Australia | 2013226073 | Alkylated cyclodextrin compositions and processes for preparing and using the same | ⤷ Sign Up |
| Canada | 2702603 | COMPOSITIONS DE CYCLODEXTRINE A GROUPEMENTS ETHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) | ⤷ Sign Up |
| Japan | 5294633 | ⤷ 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 | 2021C/504 | Belgium | ⤷ Sign Up | PRODUCT NAME: DELAFLOXACINE OU UN SEL OU ESTER DE CELLE-CI, Y COMPRIS LA DELAFLOXACINE MEGLUMINE; AUTHORISATION NUMBER AND 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 | 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 | PA2021002,C3214083 | Lithuania | ⤷ Sign Up | PRODUCT NAME: DELAFLOKSACINAS ARBA JO DRUSKA AR ESTERIS, ISKAITANT DELAFLOKSACINO MEGLUMINA; REGISTRATION NO/DATE: EU/1/19/1393 20191216 |
| 3214083 | C03214083/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: DELAFLOXACIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67238 28.05.2020 |
| 3214083 | 21C1006 | France | ⤷ Sign Up | PRODUCT NAME: DELAFLOXACINE; REGISTRATION NO/DATE: EU/1/19/1393 20191219 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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