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CAVHANZA

NDA

NILOTINIB | N217379 | FLEX PHARMA LLC

2 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

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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

78 trials from ClinicalTrials.gov — 2 recruiting, 4 active, 45 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
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
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
Frontline Asciminib Combination in Chronic Phase CML NCT03906292	Phase 2	Active	University of Jena	125	2019-08-19 → 2027-12
Adapting Treatment to the Tumor Molecular Alterations for Patients With Advanced Solid Tumors: MyOwnSpecificTreatment NCT02029001	Phase 2	Recruiting	Centre Leon Berard	900	2014-03 → 2027-10
The Drug Rediscovery Protocol (DRUP Trial)NCT02925234	Phase 2	Recruiting	The Netherlands Cancer Institute	1,550	2016-08 → 2027-12
Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase NCT00905593	—	APPROVED_FOR_MARKETING	Novartis Pharmaceuticals	—	2008-09
A Study That Switched Patients From Imatinib to Nilotinib and Then Was Followed by Treatment Cessation NCT01744665	Phase 2	Completed	Novartis Pharmaceuticals	59	2013-08-12 → 2018-09-29
Molecular Profiling of Advanced Soft-tissue Sarcomas NCT03784014	Phase 3	Completed	Institut National de la Santé Et de la Recherche Médicale, France	603	2019-10-19 → 2026-01-20
Nilotinib + Pegylated Interferon Alpha 2a for Untreated Chronic Phase Chronic Myelogenous Leukemia NCT01294618	Phase 2	Completed	Hospices Civils de Lyon	60	2011-03 → 2013-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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
11389450Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Jan 29, 2041	—	—	—		—
11559485Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Apr 30, 2041	—	—	Yes	—	—
12016861Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Jan 29, 2041	—	—	—		—
12029740Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Jan 29, 2041	—	—	Yes	—	—

#002 — 80MG

RLD

4 patents0 exclusivities▾

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