Viewing data from:

EZETIMIBE

ANDA

EZETIMIBE | A203931 | SANDOZ INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: ZETIA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
MERCK SHARP & DOHME CORP. et al v. SANDOZ INC. 2:2012cv06077 5 patentsANDA 203931ezetimibe	D.N.J.	2012-09-27	Terminated 2013-09-09	—

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

API Supply Chain31 active DMFs4 inactive

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

ALIVUS LIFE SCIENCES LTDEZETIMIBE (PROCESS I)

DMF 197172006

TAPI NL BVEZETIMIBE

DMF 200392006

MSN LABORATORIES PRIVATE LTDEZETIMIBE USP [ROUTE CODE - EB]

DMF 215542008

CHANGZHOU PHARMACEUTICAL FACTORYEZETIMIBE

DMF 245112010

NEULAND LABORATORIES LTDEZETIMIBE USP (FORM-X)

DMF 255432011

MATRIX PHARMACORP PRIVATE LTDEZETIMIBE USP

DMF 256532011

TAPI NL BVEZETIMIBE DRUG SUBSTANCE

DMF 260682012

MSN LABORATORIES PRIVATE LTDEZETIMIBE USP [ROUTE CODE - EZ]

DMF 269722013

ALIVUS LIFE SCIENCES LTDEZETIMIBE USP (PROCESS III)

DMF 273032013

DR REDDYS LABORATORIES LTDEZETIMIBE USP

DMF 278962014

LUPIN LTDEZETIMIBE USP (PROCESS-B)

DMF 281732014

MSN LABORATORIES PRIVATE LTDEZETIMIBE USP [ROUTE CODE "EE"]

DMF 291322015

HETERO LABS LTDEZETIMIBE

DMF 291582015

WUHAN ZY PHARMACEUTICAL CO LTDEZETIMIBE

DMF 296222015

HETERO LABS LTDEZETIMIBE (FORM-B)

DMF 298822015

LUPIN LTDEZETIMIBE USP (PROCESS-C)

DMF 303782016

APITORIA PHARMA PRIVATE LTDEZETIMIBE USP

DMF 308012016

MACLEODS PHARMACEUTICALS LTDEZETIMIBE

DMF 309812016

RAKS PHARMA PVT LTDEZETIMIBE USP

DMF 310822016

ZHEJIANG TIANYU PHARMACEUTICAL CO LTDEZETIMIBE

DMF 327162021

CHANGZHOU PHARMACEUTICAL FACTORYEZETIMIBE (ROUTE CODE: ZT)

DMF 359632021

APITORIA PHARMA PRIVATE LTDEZETIMIBE USP (PROCESS-II)

DMF 373682022

SAPTAGIR LABORATORIES PRIVATE LTDEZETIMIBE USP

DMF 375222022

MICRO LABS LTDEZETIMIBE USP

DMF 377282022

SAPTAGIR LABORATORIES PRIVATE LTDEZETIMIBE SILYLATED DIOL INTERMEDIATE (INTERMEDIATE OF EZETIMIBE)

DMF 380142023

DR REDDYS LABORATORIES LTDEZETIMIBE

DMF 392752023

SYMED LABS LTDEZETIMIBE USP

DMF 393392024

ZHEJIANG JINGSHENG PHARMACEUTICAL CO LTDEZETIMIBE

DMF 394102024

ALKEM LABORATORIES LTDEZETIMIBE USP

DMF 399342024

SYNTHIMED LABS PRIVATE LTDEZETIMIBE USP

DMF 408852025

SHOBHA LIFE SCIENCES PRIVATE LIMITEDEZETIMIBE USP

DMF 419142025

NEULAND LABORATORIES LTDInactiveEZETIMIBE (FORM-X)

DMF 225732009

LUPIN LTDInactiveEZETIMIBE

DMF 235412010

SIGNA SA DE CVInactiveEZETIMIBE USP

DMF 266372012

WATERSTONE PHARMACEUTICALS (HUBEI) CO LTDInactiveEZETIMIBE

DMF 289422014

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

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 12, 2017

No patent or exclusivity listings for this strength.