Viewing data from:

IBTROZI

NDA

TALETRECTINIB ADIPATE | N219713 | NUVATION BIO INC

1 strength2 unique patents2 unique exclusivities

Patent Timeline

2 unique patents, 2 exclusivities by expiration date

Active (2)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

Today

9187489

Jun. 3, 2033

9751887

Jun. 3, 2033

NCE

Jun. 11, 2030

ODE-544

Jun. 11, 2032

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 12, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 200MG BASE

RLD

2 patents2 exclusivities▴

CAPSULE;ORAL | Approved: Jun 11, 2025

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9187489	Jun 3, 2033	—	Yes	Yes		—
9751887	Jun 3, 2033	—	Yes	Yes		—

Exclusivities (2)

Code	Date	Status
NCE	Jun 11, 2030	Active
ODE-544	Jun 11, 2032	Active

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Orphan drug exclusivity was added to taletrectinib adipate (Ibtrozi, NDA 219713) based on ODE-544, providing seven-year regulatory exclusivity from approval.

New: New record