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 |
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
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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 |