Utebzi is a drug owned by Glaxosmithkline Llc. It is protected by 2 US drug patents filed in 2026 out of which none have expired yet. Utebzi's patents will be open to challenges from 17 June, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 06, 2038. Details of Utebzi'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. | |||
| US10889587 | Tebipenem Pivoxil Crystalline Forms, Compositions Including The Same, Methods Of Manufacture, And Methods Of Use |
Feb, 2038
(11 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). | |||
| US12226403 | Tebipenem Pivoxil Immediate And Modified Release Oral Dosage Forms |
Dec, 2037
(11 years from now) | Active |
FDA has granted several exclusivities to Utebzi. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Utebzi, 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
Utebzi.
Exclusivity Information
Utebzi holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2036. Details of Utebzi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 17, 2031 |
| Generating Antibiotic Incentives Now(GAIN) | Jun 17, 2036 |
US patents provide insights into the exclusivity only within the United States, but
Utebzi 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 Utebzi's family patents as well as insights into
ongoing legal events
on those patents.
Utebzi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Utebzi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 06, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Utebzi Generics:
There are no approved generic versions for Utebzi as of now.
About Utebzi
Utebzi is a drug owned by Glaxosmithkline Llc. Utebzi uses Tebipenem Pivoxil Hydrobromide as an active ingredient. Utebzi was launched by Glaxosmithkline in 2026.
Approval Date:
Utebzi was approved by FDA for market use on 17 June, 2026.
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 Utebzi is 17 June, 2026, its NCE-1 date is estimated to be 17 June, 2030.
Active Ingredient:
Utebzi uses Tebipenem Pivoxil Hydrobromide as the active ingredient. Check out other Drugs and Companies using Tebipenem Pivoxil Hydrobromide ingredient
Dosage:
Utebzi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 300MG BASE | TABLET | Prescription | ORAL |