Blujepa is a drug owned by Glaxosmithkline Llc. It is protected by 4 US drug patents filed from 2025 to 2026 out of which none have expired yet. Blujepa's patents will be open to challenges from 25 March, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 13, 2042. Details of Blujepa'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. | |||
| US12528809 | Crystalline Forms Of Gepotidacin |
Dec, 2042
(16 years from now) | Active |
| US8389524 | Tricyclic nitrogen containing compounds as antibacterial agents |
Feb, 2029
(2 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10702521 | Methods For Treating Neisseria Gonorrhoeae Infection With Substituted 1,2-Dihydro-2A,5,8A-Triazaacenaphthylene-3,8-Diones |
Aug, 2035
(9 years from now) | Active |
| US11229646 | Method For Treating Gonorrhea With (2R)-2-({4-[(3,4-Dihydro-2H-Pyrano[2,3-C]Pyridin-6-Ylmethyl)Amino]-1-Piperidinyl}Methyl)-1,2-Dihydro-3H,8H-2A,5,8A-Triazaacenaphthylene-3,8-Dione |
Aug, 2035
(9 years 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 Blujepa's patents.
Latest Legal Activities on Blujepa's Patents
Given below is the list of recent legal activities going on the following patents of Blujepa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Information Disclosure Statement (IDS) Filed | 19 Aug, 2025 | US8389524 |
| Letter from FDA or Dept of Agriculture re PTE application | 19 Aug, 2025 | US8389524 |
| Initial letter Re: PTE Application to regulating agency | 15 Jul, 2025 | US8389524 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jun, 2025 | US11229646 |
| Recordation of Patent eCertificate of Correction | 03 Jun, 2025 | US10702521 |
| Mail Patent eCofC Notification | 03 Jun, 2025 | US10702521 |
| Patent eCofC Notification | 03 Jun, 2025 | US10702521 |
| Email Notification | 03 Jun, 2025 | US10702521 |
| Patent eCofC Notification | 20 May, 2025 | US11229646 |
| Recordation of Patent eCertificate of Correction | 20 May, 2025 | US11229646 |
FDA has granted several exclusivities to Blujepa. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Blujepa, 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
Blujepa.
Exclusivity Information
Blujepa holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2035. Details of Blujepa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-978) | Dec 11, 2028 |
| New Chemical Entity Exclusivity(NCE) | Mar 25, 2030 |
| Generating Antibiotic Incentives Now(GAIN) | Mar 25, 2035 |
US patents provide insights into the exclusivity only within the United States, but
Blujepa 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 Blujepa's family patents as well as insights into
ongoing legal events
on those patents.
Blujepa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Blujepa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 13, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Blujepa Generics:
There are no approved generic versions for Blujepa as of now.
About Blujepa
Blujepa is a drug owned by Glaxosmithkline Llc. Blujepa uses Gepotidacin Mesylate as an active ingredient. Blujepa was launched by Glaxosmithkline in 2025.
Approval Date:
Blujepa was approved by FDA for market use on 25 March, 2025.
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 Blujepa is 25 March, 2025, its NCE-1 date is estimated to be 25 March, 2029.
Active Ingredient:
Blujepa uses Gepotidacin Mesylate as the active ingredient. Check out other Drugs and Companies using Gepotidacin Mesylate ingredient
Dosage:
Blujepa is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 750MG BASE | TABLET | Prescription | ORAL |