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Jadenu

deferasirox · Tablet, Film Coated

Prescription NDA TE AB RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Jadenu
Generic name
deferasirox
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Novartis Pharmaceuticals Corporation
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
3
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Deferasirox 180 mg/1 597768 View
Deferasirox 360 mg/1 597768 View
Deferasirox 90 mg/1 597768 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
6

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cytochrome P450 1A2 Inhibitors [MoA] MoA All 31 members
Cytochrome P450 2C8 Inhibitors [MoA] MoA All 56 members
Cytochrome P450 3A4 Inducers [MoA] MoA All 54 members
Iron Chelating Activity [MoA] MoA All 14 members
Iron Chelator [EPC] EPC All 14 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
206910
Application type
NDA · New Drug Application
Approval date
March 30, 2015
Sponsor
NOVARTIS PHARMS CORP
Products on application
3
Submissions recorded
15
Products approved under application 206910.
Product Trade name Form Strength Ingredient Status TE Flags
206910-001 JADENU TABLET DEFERASIROX Prescription AB RLD
206910-002 JADENU TABLET DEFERASIROX Prescription AB RLD
206910-003 JADENU TABLET DEFERASIROX Prescription AB RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
AB
Reference Listed Drug
Yes
Reference Standard
Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9283209 November 21, 2034 001 Yes April 11, 2016
9283209 November 21, 2034 002 Yes April 11, 2016
9283209 November 21, 2034 003 Yes April 11, 2016

Approval history

Source: Drugs@FDA
Most recent submissions on application 206910.
Type No. Action Status Date Review
Supplement 19 Manufacturing (CMC) Approved February 11, 2022 N/A
Supplement 15 Efficacy Approved July 23, 2020 Standard
Supplement 12 Efficacy Approved July 26, 2019 Standard
Supplement 14 Efficacy Approved May 24, 2019 Priority
Supplement 11 Labeling Approved December 12, 2018 Standard
Supplement 9 Efficacy Approved December 12, 2018 Priority
Supplement 10 Labeling Approved August 3, 2018 Standard
Supplement 6 Efficacy Approved May 11, 2018 Standard
Supplement 7 Labeling Approved February 16, 2018 Standard
Supplement 5 Labeling Approved January 26, 2018 Standard
Supplement 4 Labeling Approved August 12, 2016 Standard
Supplement 2 Manufacturing (CMC) Approved November 6, 2015 Priority
Supplement 3 Labeling Approved October 22, 2015 Standard
Supplement 1 Labeling Approved October 22, 2015 Standard
Original application 1 Type 5 - New Formulation or New Manufacturer Approved March 30, 2015 Standard

Review documents

  • 0 · Supplement · November 14, 2024
  • 0 · Supplement · November 14, 2024
  • 0 · Supplement · July 27, 2020
  • 0 · Supplement · July 27, 2020
  • 0 · Supplement · July 27, 2020
  • 0 · Supplement · July 29, 2019
  • 0 · Supplement · July 29, 2019
  • 0 · Supplement · July 26, 2019
  • 0 · Supplement · June 4, 2019
  • 0 · Supplement · May 29, 2019
  • 0 · Supplement · December 20, 2018
  • 0 · Supplement · December 20, 2018
  • 0 · Supplement · December 14, 2018
  • 0 · Supplement · December 14, 2018
  • 0 · Supplement · August 7, 2018
  • 0 · Supplement · August 6, 2018
  • 0 · Supplement · May 16, 2018
  • 0 · Supplement · May 14, 2018
  • 0 · Supplement · February 23, 2018
  • 0 · Supplement · February 22, 2018
  • 0 · Supplement · January 30, 2018
  • 0 · Supplement · January 30, 2018
  • 0 · Supplement · August 17, 2016
  • 0 · Supplement · August 12, 2016
  • 0 · Original application · August 4, 2016
  • 0 · Supplement · October 26, 2015
  • 0 · Supplement · October 26, 2015
  • 0 · Supplement · October 26, 2015
  • 0 · Supplement · October 26, 2015
  • 0 · Original application · April 7, 2015

Adverse event reports

Source: openFDA FAERS
26,368
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DEFERASIROX. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0078-0654-15 0078-0654 Novartis Pharmaceuticals Corporation 30 TABLET, FILM COATED in 1 BOTTLE (0078-0654-15) March 30, 2015
0078-0655-15 0078-0655 Novartis Pharmaceuticals Corporation 30 TABLET, FILM COATED in 1 BOTTLE (0078-0655-15) March 30, 2015
0078-0656-15 0078-0656 Novartis Pharmaceuticals Corporation 30 TABLET, FILM COATED in 1 BOTTLE (0078-0656-15) March 30, 2015
0078-0654 0078-0654 Novartis Pharmaceuticals Corporation — March 30, 2015
0078-0655 0078-0655 Novartis Pharmaceuticals Corporation — March 30, 2015
0078-0656 0078-0656 Novartis Pharmaceuticals Corporation — March 30, 2015

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.