Komzifti is a drug owned by Kura Oncology Inc. It is protected by 7 US drug patents filed in 2025 out of which none have expired yet. Komzifti's patents will be open to challenges from 13 November, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 16, 2044. Details of Komzifti'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. | |||
| US12410184 | NA |
Jul, 2044
(18 years from now) | Active |
| US10781218 | NA |
Mar, 2037
(11 years from now) | Active |
| US10077271 | NA |
Mar, 2036
(10 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). | |||
| US11944627 | NA |
Sep, 2038
(12 years from now) | Active |
| US11673898 | NA |
Mar, 2037
(11 years from now) | Active |
| US10869868 | NA |
Jan, 2037
(11 years from now) | Active |
| US10174041 | NA |
Mar, 2036
(10 years from now) | Active |
FDA has granted several exclusivities to Komzifti. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Komzifti, 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
Komzifti.
Exclusivity Information
Komzifti holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Komzifti's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 13, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Komzifti 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 Komzifti's family patents as well as insights into
ongoing legal events
on those patents.
Komzifti's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Komzifti's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 16, 2044 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Komzifti Generics:
There are no approved generic versions for Komzifti as of now.
About Komzifti
Komzifti is a drug owned by Kura Oncology Inc. Komzifti uses Ziftomenib as an active ingredient. Komzifti was launched by Kura in 2025.
Approval Date:
Komzifti was approved by FDA for market use on 13 November, 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 Komzifti is 13 November, 2025, its NCE-1 date is estimated to be 13 November, 2029.
Active Ingredient:
Komzifti uses Ziftomenib as the active ingredient. Check out other Drugs and Companies using Ziftomenib ingredient
Dosage:
Komzifti is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | CAPSULE | Prescription | ORAL |