Viewing data from:

JADENU SPRINKLE

NDA

DEFERASIROX | N207968 | NOVARTIS PHARMACEUTICALS CORP

3 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Jadenu Sprinkle (2023)

Total Spending

$555K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$149.36

Spending Trend

$4.2M(2019)→$3.8M(2020)→$919K(2021)→$491K(2022)→$555K(2023)

YoY Change:+36.5%

5yr CAGR:+0.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain22 active DMFs5 inactive

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

MATRIX PHARMACORP PRIVATE LTDDEFERASIROX

DMF 223692008

ALIVUS LIFE SCIENCES LTDDEFERASIROX

DMF 242092010

NEULAND LABORATORIES LTDDEFERASIROX

DMF 257332012

MSN LABORATORIES PRIVATE LTDDEFERASIROX [ROUTE CODE - "DR"]

DMF 258372012

JUBILANT BIOSYS LTDDEFERASIROX

DMF 258882012

PURE AND CURE HEALTHCARE PRIVATE LTDDEFERASIROX

DMF 259642012

ALEMBIC PHARMACEUTICALS LTDDEFERASIROX

DMF 268332013

TAPI NL BVDEFERASIROX

DMF 276482014

BIOCON LTDDEFERASIROX

DMF 286262015

SUN PHARMACEUTICAL INDUSTRIES LTDDEFERASIROX

DMF 293202015

TAPI NL BVDEFERASIROX

DMF 295482015

MEDILUX LABORATORIES PVT LTDDEFERASIROX

DMF 306952016

CIPLA LTDDEFERASIROX

DMF 308172016

PIRAMAL PHARMA LTDDEFERASIROX

DMF 314852017

YUNG ZIP CHEMICAL IND CO LTDDEFERASIROX

DMF 315992017

SYMED LABS LTDDEFERASIROX

DMF 318772019

APITORIA PHARMA PRIVATE LTDDEFERASIROX

DMF 341912019

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)DEFERASIROX

DMF 356512021

CTX LIFESCIENCES PVT LTDDEFERASIROX

DMF 389632023

ZHEJIANG HENGKANG PHARMACEUTICAL CO LTDDEFERASIROX

DMF 410512024

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDDEFERASIROX

DMF 412022025

SMS PHARMACEUTICALS LTDDEFERASIROX

DMF 419172025

BACHEM SAInactiveDEFERASIROX

DMF 260032012

ERREGIERRE SPAInactiveDEFERASIROX

DMF 264682012

APOTEX PHARMACHEM INDIA PVT LTDInactiveDEFERASIROX

DMF 283792014

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDInactiveDEFERASIROX

DMF 288052014

CTX LIFE SCIENCES PVT LTDInactiveDEFERASIROX

DMF 302132016

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Jul 24, 2020	SUPPL -9	View Letter (PDF)
Jul 26, 2019	SUPPL -7	View Letter (PDF)
Jun 4, 2019	SUPPL -8	View Letter (PDF)
Dec 20, 2018	SUPPL -4	View Letter (PDF)
Dec 20, 2018	SUPPL -6	View Letter (PDF)
Aug 7, 2018	SUPPL -5	View Letter (PDF)
May 16, 2018	SUPPL -1	View Letter (PDF)
Feb 23, 2018	SUPPL -2	View Letter (PDF)
May 19, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 90MG

RLDAB

0 patents0 exclusivities▴

GRANULE;ORAL | Approved: May 18, 2017

No patent or exclusivity listings for this strength.

#002 — 180MG

RLDAB

0 patents0 exclusivities▾

GRANULE;ORAL | Approved: May 18, 2017

#003 — 360MG

RLDAB

0 patents0 exclusivities▾

GRANULE;ORAL | Approved: May 18, 2017