Blujepa is a drug owned by Glaxosmithkline Llc. It is protected by 1 US drug patent filed in 2025 out of which none have expired yet. Blujepa's patents will be open to challenges from 25 March, 2034. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 25, 2035. 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. | |||
| US8389524 | Tricyclic nitrogen containing compounds as antibacterial agents |
Feb, 2029
(3 years from now) | Active |
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 2 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 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 Mar 25, 2035 (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, 2034.
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 |