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DEFERASIROX

ANDA

DEFERASIROX | A211641 | SUN PHARMACEUTICAL INDUSTRIES LTD

3 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
SUN PHARMACEUTICAL INDUSTRIES LIMITED v. NOVARTIS PHARMACEUTICALS CORP. et al 2:2019cv00276 2 patentsANDA 211641deferasirox	D.N.J.	2019-01-09	Terminated 2019-04-04	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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

2 letters from Drugs@FDA

Date	Submission	Document
Mar 17, 2020	ORIG -2	View Letter (PDF)
Mar 17, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 90MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 2, 2020

No patent or exclusivity listings for this strength.

#002 — 360MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 2, 2020

#003 — 180MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 15, 2020