Viewing data from:

CAVHANZA

NDA

NILOTINIB | N217379 | FLEX PHARMA LLC

2 strengths0 unique patents0 unique exclusivities

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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase NCT05143840	Phase 2	Recruiting	University of Alabama at Birmingham	100	2022-04-22 → 2032-02

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

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

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 80MG

RLD

0 patents0 exclusivities▾

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

Change History (2)

Recent changes detected for this application.

ADDED7/1/2026

Flex Pharma received FDA approval for CAVHANZA (nilotinib) under NDA 217379, Supplement 002.

New: New record

ADDED7/1/2026

CAVHANZA (nilotinib) NDA 217379 received FDA approval as a new product formulation by Flex Pharma.

New: New record