BAXDELA Drug Patent Profile
✉ Email this page to a colleague
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 fifteen patents protecting this drug.
This drug has one hundred and sixty-five patent family members in forty-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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for BAXDELA?
- What are the global sales for BAXDELA?
- What is Average Wholesale Price for BAXDELA?
Summary for BAXDELA
International Patents: | 165 |
US Patents: | 15 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 77 |
Patent Applications: | 387 |
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 |
US Patents and Regulatory Information for BAXDELA
BAXDELA is protected by fifteen US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BAXDELA is ⤷ Try for Free.
This potential generic entry date is based on patent 7,728,143.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 8,252,813 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Melinta | BAXDELA | delafloxacin meglumine | TABLET;ORAL | 208610-001 | Jun 19, 2017 | RX | Yes | Yes | 8,648,093 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Melinta | BAXDELA | delafloxacin meglumine | TABLET;ORAL | 208610-001 | Jun 19, 2017 | RX | Yes | Yes | RE46617 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
Melinta | BAXDELA | delafloxacin meglumine | POWDER;INTRAVENOUS | 208611-001 | Jun 19, 2017 | RX | Yes | Yes | 9,750,822 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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 |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 2006042034 | ⤷ Try for Free | |
Poland | 3766876 | ⤷ Try for Free | |
China | 102215690 | Antimicrobial compositions | ⤷ Try for Free |
Mexico | 353603 | COMPOSICIONES DE CICLODEXTRINA ALQUILADA Y PROCESOS PARA PREPARAR Y UTILIZAR LAS MISMAS. (ALKYLATED CYCLODEXTRIN COMPOSITIONS AND PROCESSES FOR PREPARING AND USING THE SAME.) | ⤷ Try for Free |
>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 | ⤷ Try for Free | 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,C3214083 | Lithuania | ⤷ Try for Free | PRODUCT NAME: DELAFLOKSACINAS ARBA JO DRUSKA AR ESTERIS, ISKAITANT DELAFLOKSACINO MEGLUMINA; REGISTRATION NO/DATE: EU/1/19/1393 20191216 |
3214083 | 301091 | Netherlands | ⤷ Try for Free | PRODUCT NAME: DELAFLOXACINE, OF EEN ZOUT OF ESTERS ERVAN, MET INBEGRIP VAN DELAFLOXACINE MEGLUMINE; REGISTRATION NO/DATE: EU/1/19/1393 20191219 |
3214083 | LUC00196 | Luxembourg | ⤷ Try for Free | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for BAXDELA
More… ↓