Viewing data from:

CAVHANZA

NDA

NILOTINIB | N217379 | FLEX PHARMA LLC

2 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

Today

Jan. 29, 2041

Apr. 30, 2041

Jan. 29, 2041

Jan. 29, 2041

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

90 trials from ClinicalTrials.gov — 6 recruiting, 7 active, 49 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP NCT04971226	Phase 3	Active	Novartis Pharmaceuticals	405	2021-10-06 → 2031-01-18
Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients With Prior Taxane Treatment, A ComboMATCH Treatment Trial NCT05554341	Phase 2	Active	National Cancer Institute (NCI)	40	2023-07-14 → 2027-06-30
Pembrolizumab and Dasatinib, Imatinib Mesylate, or Nilotinib in Treating Patients With Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease NCT03516279	Phase 2	Active	ECOG-ACRIN Cancer Research Group	40	2019-06-26 → 2031-08-31
Efficacy and Safety of TKIs' Withdrawal After a Two-step Dose Reduction in Patients with Chronic Myeloid Leukemia NCT04147533	Phase 2	Active	Masaryk University	150	2020-06-16 → 2026-06
Frontline Asciminib Combination in Chronic Phase CML NCT03906292	Phase 2	Active	University of Jena	125	2019-08-19 → 2027-12
A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)NCT05456191	Phase 3	Active	Novartis Pharmaceuticals	568	2022-11-21 → 2031-07-07
Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia NCT03654768	Phase 2	Active	SWOG Cancer Research Network	81	2018-10-24 → 2028-07-01
Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel NCT04449549	Phase 2	Recruiting	National Cancer Institute (NCI)	82	2020-08-24 → 2027-04-08
Asciminib Roll-over Study NCT04877522	Phase 4	Recruiting	Novartis Pharmaceuticals	347	2022-08-30 → 2030-08-30
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial NCT05564377	Phase 2	Recruiting	National Cancer Institute (NCI)	2,900	2023-04-07 → 2030-07-01

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

API Supply Chain7 active DMFs2 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

HIKMA PHARMACEUTICALS PLCNILOTINIB MONOHYDROCHLORIDE ANHYDROUS

DMF 301642015

MSN LABORATORIES PRIVATE LTDNILOTINIB

DMF 331962018

SUN PHARMACEUTICAL INDUSTRIES LTDNILOTINIB BUTANEDISULFONATE

DMF 354362020

SHILPA PHARMA LIFESCIENCES LTDNILOTINIB

DMF 362892021

SICHUAN ELIXIR PHARMACEUTICAL CO LTDNILOTINIB

DMF 396482024

HUBEI HAOSUN PHARMACEUTICAL CO LTDNILOTINIB HYDROCLORIDE MONOHYDRATE

DMF 418192025

DR REDDYS LABORATORIES LTDNILOTINIB PREMIX (HPMC AS)

DMF 432722025

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveNILOTINIB

DMF 264972012

FIS FABBRICA ITALIANA SINTETICI SPAInactiveNILOTINIB DIHYDROCHLORIDE DIHYDRATE

DMF 317402017

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 2, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 60MG

RLD

4 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: May 29, 2026

Patents (4) · 4 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11389450	Jan 29, 2041	—	—	—		—
11559485	Apr 30, 2041	—	—	Yes	—	—
12016861	Jan 29, 2041	—	—	—		—
12029740	Jan 29, 2041	—	—	Yes	—	—

#002 — 80MG

RLD

4 patents0 exclusivities▾

TABLET, ORALLY DISINTEGRATING;ORAL | Approved: May 29, 2026