Ibtrozi is a drug owned by Nuvation Bio Inc. It is protected by 2 US drug patents filed in 2025 out of which none have expired yet. Ibtrozi's patents will be open to challenges from 11 June, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 03, 2033. Details of Ibtrozi'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. | |||
| US9751887 | Imidazo[1,2-b]pyridazine derivatives as kinase inhibitors |
Jun, 2033
(7 years from now) | Active |
| US9187489 | Imidazo[1,2-b]pyridazine derivatives as kinase inhibitors |
Jun, 2033
(7 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 Ibtrozi's patents.
Latest Legal Activities on Ibtrozi's Patents
Given below is the list of recent legal activities going on the following patents of Ibtrozi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Initial letter Re: PTE Application to regulating agency | 05 Aug, 2025 | US9751887 |
| Initial letter Re: PTE Application to regulating agency | 05 Aug, 2025 | US9187489 |
| Patent Term Extension Application under 35 USC 156 Filed | 01 Aug, 2025 | US9751887 |
| Patent Term Extension Application under 35 USC 156 Filed | 01 Aug, 2025 | US9187489 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Mar, 2025 | US9751887 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 May, 2023 | US9187489 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 Mar, 2021 | US9751887 |
| Change in Power of Attorney (May Include Associate POA) | 19 Oct, 2020 | US9751887 |
| Email Notification | 19 Oct, 2020 | US9751887 |
| Change in Power of Attorney (May Include Associate POA) | 19 Oct, 2020 | US9187489 |
FDA has granted several exclusivities to Ibtrozi. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Ibtrozi, 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
Ibtrozi.
Exclusivity Information
Ibtrozi holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Ibtrozi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 11, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Ibtrozi 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 Ibtrozi's family patents as well as insights into
ongoing legal events
on those patents.
Ibtrozi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ibtrozi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 03, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ibtrozi Generics:
There are no approved generic versions for Ibtrozi as of now.
About Ibtrozi
Ibtrozi is a drug owned by Nuvation Bio Inc. Ibtrozi uses Taletrectinib Adipate as an active ingredient. Ibtrozi was launched by Nuvation in 2025.
Approval Date:
Ibtrozi was approved by FDA for market use on 11 June, 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 Ibtrozi is 11 June, 2025, its NCE-1 date is estimated to be 11 June, 2029.
Active Ingredient:
Ibtrozi uses Taletrectinib Adipate as the active ingredient. Check out other Drugs and Companies using Taletrectinib Adipate ingredient
Dosage:
Ibtrozi is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE | CAPSULE | Prescription | ORAL |