Nuzolvence is a drug owned by Entasis Therapeutics Inc. It is protected by 6 US drug patents filed in 2026 out of which none have expired yet. Nuzolvence's patents will be open to challenges from 12 December, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 12, 2035. Details of Nuzolvence'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. | |||
| US8889671 | Compounds And Methods For Treating Bacterial Infections |
Jan, 2034
(7 years from now) | Active |
| US9187495 | Compounds And Methods For Treating Bacterial Infections |
Jan, 2034
(7 years from now) | Active |
| US8658641 | Fused, Spirocyclic Heteroaromatic Compounds For The Treatment Of Bacterial Infections |
Jun, 2030
(4 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). | |||
| US9839641 | Compounds And Methods For Treating Bacterial Infections |
Jan, 2034
(7 years from now) | Active |
| US9540394 | Compounds And Methods For Treating Bacterial Infections |
Jan, 2034
(7 years from now) | Active |
| US9040528 | Chemical Compounds 542 |
Oct, 2029
(3 years from now) | Active |
FDA has granted several exclusivities to Nuzolvence. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Nuzolvence, 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
Nuzolvence.
Exclusivity Information
Nuzolvence holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2035. Details of Nuzolvence's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 12, 2030 |
| Generating Antibiotic Incentives Now(GAIN) | Dec 12, 2035 |
US patents provide insights into the exclusivity only within the United States, but
Nuzolvence 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 Nuzolvence's family patents as well as insights into
ongoing legal events
on those patents.
Nuzolvence's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nuzolvence's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 12, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nuzolvence Generics:
There are no approved generic versions for Nuzolvence as of now.
About Nuzolvence
Nuzolvence is a drug owned by Entasis Therapeutics Inc. Nuzolvence uses Zoliflodacin as an active ingredient. Nuzolvence was launched by Entasis in 2025.
Approval Date:
Nuzolvence was approved by FDA for market use on 12 December, 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 Nuzolvence is 12 December, 2025, its NCE-1 date is estimated to be 12 December, 2029.
Active Ingredient:
Nuzolvence uses Zoliflodacin as the active ingredient. Check out other Drugs and Companies using Zoliflodacin ingredient
Dosage:
Nuzolvence is available in for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3GM/PACKET | FOR SUSPENSION | Prescription | ORAL |