Baxdela Patent Expiration

Baxdela is a drug owned by Melinta Subsidiary Corp. It is protected by 14 US drug patents filed from 2017 to 2018 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 27, 2033. 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9539250 Salt and crystalline forms thereof of a drug
Oct, 2025

(1 year, 2 months from now)

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

(2 years from now)

Active
US8871938 Process for making quinolone compounds
Sep, 2029

(5 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
US7728143 Salt and crystalline forms thereof of a drug
Jun, 2031

(6 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8648093 Salt and crystalline forms thereof of a drug
Oct, 2025

(1 year, 2 months from now)

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

(1 year, 2 months from now)

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

(2 years from now)

Active
US9200088 Sulfoalkyl ether cyclodextrin compositions
Mar, 2029

(4 years from now)

Active
US9750822 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
US9493582 Alkylated cyclodextrin compositions and processes for preparing and using the same
Feb, 2033

(8 years from now)

Active


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.

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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 Feb 27, 2033 (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.

Market Authorisation Date:

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

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. 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 - powder form for intravenous use, tablet form for oral 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