Baxdela Patent Expiration

Baxdela is a drug owned by Melinta Subsidiary Corp. It is protected by 15 US drug patents filed from 2017 to 2024 out of which none have expired yet. Baxdela's patents will be open to challenges from 19 June, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 02, 2034. Details of Baxdela's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US7728143 Salt and crystalline forms thereof of a drug
Jun, 2031

(6 years from now)

Active
US8497378 Process for making quinolone compounds
Dec, 2029

(5 years from now)

Active
USRE46617 Process for making quinolone compounds
Dec, 2029

(5 years from now)

Active
US8871938 Process for making quinolone compounds
Sep, 2029

(4 years from now)

Active
US8273892 Salt and crystalline forms thereof of a drug
Aug, 2026

(1 year, 9 months from now)

Active
US9539250 Salt and crystalline forms thereof of a drug
Oct, 2025

(11 months from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US12036219 Methods of treating infections in overweight and obese patients using antibiotics
Jun, 2034

(9 years from now)

Active
US9493582 Alkylated cyclodextrin compositions and processes for preparing and using the same
Feb, 2033

(8 years from now)

Active
US9750822 Sulfoalkyl ether cyclodextrin compositions
Mar, 2029

(4 years from now)

Active
US9200088 Sulfoalkyl ether cyclodextrin compositions
Mar, 2029

(4 years from now)

Active
US7635773 Sulfoalkyl ether cyclodextrin compositions
Mar, 2029

(4 years from now)

Active
US8410077 Sulfoalkyl ether cyclodextrin compositions
Mar, 2029

(4 years from now)

Active
US8252813 Salt and crystalline forms thereof of a drug
Oct, 2026

(1 year, 11 months from now)

Active
US8648093 Salt and crystalline forms thereof of a drug
Oct, 2025

(11 months from now)

Active
US8969569 Salt and crystalline forms thereof of a drug
Oct, 2025

(11 months from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Baxdela's patents.

Given below is the list of recent legal activities going on the following patents of Baxdela.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 13 Jun, 2024 US9539250
Payment of Maintenance Fee, 8th Year, Large Entity 30 Apr, 2024 US9493582
Payment of Maintenance Fee, 12th Year, Large Entity 08 Feb, 2024 US8273892
Payment of Maintenance Fee, 12th Year, Large Entity 11 Jan, 2024 US8252813
Payment of Maintenance Fee, 8th Year, Large Entity 17 May, 2023 US9200088
Correspondence Address Change 04 Dec, 2022 US8410077
Correspondence Address Change 04 Dec, 2022 US9200088
Correspondence Address Change 04 Dec, 2022 US7635773
Correspondence Address Change 04 Dec, 2022 US9493582
Correspondence Address Change 04 Dec, 2022 US9750822


FDA has granted several exclusivities to Baxdela. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Baxdela, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Baxdela.

Exclusivity Information

Baxdela holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Baxdela's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jun 19, 2022
New Indication(I-815) Oct 24, 2022
Generating Antibiotic Incentives Now(GAIN) Jun 19, 2027

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US patents provide insights into the exclusivity only within the United States, but Baxdela is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Baxdela's family patents as well as insights into ongoing legal events on those patents.

Baxdela's Family Patents

Baxdela has patent protection in a total of 26 countries. It's US patent count contributes only to 25.9% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Baxdela.

Family Patents

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Generic Launch

Generic Release Date:

Baxdela's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 02, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Baxdela Generics:

There are no approved generic versions for Baxdela as of now.





About Baxdela

Baxdela is a drug owned by Melinta Subsidiary Corp. It is used for treating acute bacterial skin infections in adults. Baxdela uses Delafloxacin Meglumine as an active ingredient. Baxdela was launched by Melinta in 2017.

Approval Date:

Baxdela was approved by FDA for market use on 19 June, 2017.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Baxdela is 19 June, 2017, its NCE-1 date is estimated to be 19 June, 2026.

Active Ingredient:

Baxdela uses Delafloxacin Meglumine as the active ingredient. Check out other Drugs and Companies using Delafloxacin Meglumine ingredient

Treatment:

Baxdela is used for treating acute bacterial skin infections in adults.

Dosage:

Baxdela is available in the following dosage forms - tablet form for oral use, powder form for intravenous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 300MG BASE/VIAL POWDER Prescription INTRAVENOUS
EQ 450MG BASE TABLET Prescription ORAL