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IMATINIB MESYLATE

ANDA

IMATINIB MESYLATE | A208302 | SHILPA MEDICARE LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: GLEEVEC(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Novartis Pharmaceuticals Corporation et al v. Shilpa Medicare Limited 1:2015cv01111 2 patentsANDA 208302imatinib mesylate	D. Del.	2015-11-30	Terminated 2016-07-27	—

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

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.

Products (2)

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#001 — EQ 100MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 17, 2019

No patent or exclusivity listings for this strength.

#002 — EQ 400MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 17, 2019