Baxdela is a drug owned by Melinta Subsidiary Corp. It is protected by 16 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
(5 years from now) | Active |
| USRE46617 | Process for making quinolone compounds |
Dec, 2029
(4 years from now) | Active |
| US8497378 | Process for making quinolone compounds |
Dec, 2029
(4 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, 11 days from now) | Active |
| US9539250 | Salt and crystalline forms thereof of a drug |
Oct, 2025
(2 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
(8 years from now) | Active |
| US9493582 | Alkylated cyclodextrin compositions and processes for preparing and using the same |
Feb, 2033
(7 years from now) | Active |
| US12138257 | Antimicrobial compositions |
May, 2032
(6 years from now) | Active |
| US9750822 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(3 years from now) | Active |
| US9200088 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(3 years from now) | Active |
| US7635773 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(3 years from now) | Active |
| US8410077 | Sulfoalkyl ether cyclodextrin compositions |
Mar, 2029
(3 years from now) | Active |
| US8252813 | Salt and crystalline forms thereof of a drug |
Oct, 2026
(1 year, 2 months from now) | Active |
| US8648093 | Salt and crystalline forms thereof of a drug |
Oct, 2025
(2 months from now) | Active |
| US8969569 | Salt and crystalline forms thereof of a drug |
Oct, 2025
(2 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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 04 Dec, 2022 | US8410077 |
| Correspondence Address Change Critical | 04 Dec, 2022 | US9200088 |
| Correspondence Address Change Critical | 04 Dec, 2022 | US7635773 |
| Correspondence Address Change Critical | 04 Dec, 2022 | US9493582 |
| Correspondence Address Change Critical | 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 |
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
Explore Our Curated Drug Screens
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 - 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 |