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NDA

IMATINIB MESYLATE | N021335 | NOVARTIS PHARMACEUTICALS CORP

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Novartis Pharmaceuticals Corporation et al v. Dr. Reddy's Laboratories Ltd. et al 1:2014cv01283 2 patentsANDA 206898imatinib mesylate	D. Del.	2014-10-08	Terminated 2015-06-22	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and Efficacy of Imatinib in Combination With Artemether-Lumefantrine for Uncomplicated Malaria NCT07559370	Phase 2	Recruiting	Victoria Biomedical Research Institute	1,116	2026-01-20 → 2027-06-30
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency NCT06090669	Phase 1	Recruiting	National Cancer Institute (NCI)	75	2023-12-19 → 2027-10-30

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

Medicare Part D Spending

CMS annual spending data for Gleevec (2023)

Total Spending

$73.3M

Total Claims

6,815

Beneficiaries

865

Avg Cost/Unit

$249.77

Spending Trend

$170.3M(2019)→$136.3M(2020)→$106.4M(2021)→$90.8M(2022)→$73.3M(2023)

YoY Change:+0.1%

5yr CAGR:-1.0%

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

API Supply Chain26 active DMFs11 inactive

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

SUN PHARMACEUTICAL INDUSTRIES LTDIMATINIB MESYLATE

DMF 194992006

NATCO PHARMA LTDIMATINIB MESYLATE (ALPHA 2-FORM)

DMF 204102007

TAPI NL BVIMATINIB MESYLATE

DMF 210062007

ZHEJIANG JIUZHOU PHARMACEUTICAL CO LTDIMATINIB MESYLATE

DMF 233432009

RELIANCE LIFE SCIENCES PVT LTDIMATINIB MESYLATE

DMF 242072011

DR REDDYS LABORATORIES LTDIMATINIB MESYLATE

DMF 248112011

TAI HENG INDUSTRY GROUP CO LTDIMATINIB MESYLATE

DMF 248382011

FIS FABBRICA ITALIANA SINTETICI SPAIMATINIB MESYLATE (BETA FORM)

DMF 252052011

FIS FABBRICA ITALIANA SINTETICI SPAIMATINIB MESYLATE (ALPHA FORM)

DMF 252062011

CIPLA LTDIMATINIB MESYLATE (A-FORM)

DMF 261702013

ACEBRIGHT INDIA PHARMA PRIVATE LTDIMATINIB MESYLATE [DRUG SUBSTANCE(NON-STERILE)]

DMF 263222012

MSN LABORATORIES PRIVATE LTDIMATINIB MESYLATE [ROUTE CODE-" IT"]

DMF 263862012

ACEBRIGHT INDIA PHARMA PRIVATE LTDIMATINIB MESYLATE A-FORM [DRUG SUBSTANCE(NON-STERILE)]

DMF 264242012

HETERO LABS LTDIMATINIB MESYLATE (FORM-A)

DMF 266872012

LAURUS LABS LTDIMATINIB MESYLATE

DMF 270892013

SHILPA PHARMA LIFESCIENCES LTDIMATINIB MESYLATE

DMF 279272014

TAPI NL BVIMATINIB MESYLATE FORM ALPHA

DMF 281822014

SHILPA PHARMA LIFESCIENCES LTDIMATINIB MESYLATE (IMN)

DMF 283492014

SHANDONG ANXIN PHARMACEUTICAL CO LTDIMATINIB MESYLATE (NON-STERILE API)

DMF 296562015

ZYDUS LIFESCIENCES LTDIMATINIB MESYLATE

DMF 308712016

HETERO LABS LTDIMATINIB MESYLATE (FORM-B)

DMF 309602016

MSN LABORATORIES PRIVATE LTDIMATINIB MESYLATE

DMF 323942017

LAURUS LABS LTDIMATINIB MESYLATE (PROCESS-2)

DMF 333122018

ZYDUS LIFESCIENCES LTDIMATINIB MESYLATE (PROCESS II)

DMF 344762019

FORMOSA LABORATORIES INCIMATINIB MESYLATE

DMF 351532020

APITORIA PHARMA PRIVATE LTDIMATINIB MESYLATE

DMF 362382021

MYLAN LABORATORIES LTDInactiveIMATINIB MESYLATE

DMF 231392009

PHF SAInactiveIMATINIB MESYLATE

DMF 242872010

WAVELENGTH ENTERPRISES LTDInactiveIMATINIB MESYLATE ALPHA FORM

DMF 249712011

HETERO LABS LTDInactiveIMATINIB MESYLATE AMORPHOUS

DMF 251162011

SICHUAN XIELI PHARMACEUTICAL CO LTDInactiveIMATINIB MESYLATE

DMF 263622012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveIMATINIB MESYLATE

DMF 266062012

CADILA HEALTHCARE LTDInactiveIMATINIB MESYLATE (AMORPHOUS)

DMF 276692013

SIGNA SA DE CVInactiveIMATINIB MESYLATE

DMF 281922016

CIPLA LTDInactiveIMATINIB MESYLATE (BETA FORM)

DMF 283332014

KYONGBO PHARMACEUTICAL CO LTDInactiveIMATINIB MESYLATE

DMF 285112014

INTAS PHARMACEUTICALS LTDInactiveIMATINIB MESYLATE (ß-FORM)

DMF 322702017

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jun 4, 2004	SUPPL -4	View Letter (PDF)
Nov 25, 2003	SUPPL -6	View Letter (PDF)
Jul 23, 2003	SUPPL -3	View Letter (PDF)
Feb 1, 2002	SUPPL -1	View Letter (PDF)
May 10, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 10, 2001

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 10, 2001