Viewing data from:

ZESTRIL

NDA

LISINOPRIL | N019777 | TWI PHARMACEUTICALS INC

6 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 Zestril (2023)

Total Spending

$4.0M

Total Claims

3,487

Beneficiaries

956

Avg Cost/Unit

$13.27

Spending Trend

$5.5M(2019)→$5.8M(2020)→$5.3M(2021)→$4.9M(2022)→$4.0M(2023)

YoY Change:+0.1%

5yr CAGR:+0.6%

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

API Supply Chain9 active DMFs14 inactive

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

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDLISINOPRIL DIHYDRATE, USP

DMF 148012000

LUPIN LTDLISINOPRIL USP

DMF 150982000

HETERO DRUGS LTDLISINOPRIL

DMF 165102003

UNIMARK REMEDIES LTDLISINOPRIL USP

DMF 176262004

EVONIK OPERATIONS GMBHLISINOPRIL DIHYDRATE

DMF 191382006

ZHEJIANG CHANGMING PHARMACEUTICAL CO LTDLISINOPRIL DIHYDRATE USP (NON-STERILE)

DMF 273852013

EMCURE PHARMACEUTICALS LTDLISINOPRIL USP

DMF 356202021

HETERO DRUGS LTDLISINOPRIL PROCESS-III

DMF 381322023

MSN LIFE SCIENCES PRIVATE LTDLISINOPRIL USP

DMF 417012025

ZENECA PHARMACEUTICALSInactiveLISINOPRIL DIHYDRATE

DMF 71411987

EVONIK TECHNOCHEMIE GMBHInactiveLISINOPRIL (TFA)-ETHYLESTER

DMF 97661992

DEGUSSA AG WERK RADEBEULInactiveLISINOPRIL (TFA)-ETHYLESTER

DMF 97671992

ASTRAZENECA PHARMACEUTICALS LPInactiveLISINOPRIL BULK DRUG

DMF 108531994

FARMHISPANIA SAInactiveLISINOPRIL USP

DMF 115351995

GEDEON RICHTER LTDInactiveLISINOPRIL

DMF 129121998

ESTEVE QUIMICA SAInactiveLISINOPRIL

DMF 129681998

EVONIK CORPInactiveLISINOPRIL CRUDE

DMF 145361999

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveLISINOPRIL DRUG SUBSTANCE

DMF 147742000

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveLISINOPRIL USP (NON-STERILE BULK)

DMF 149952000

LEK PHARMACEUTICALS DDInactiveLISINOPRIL ACTIVE DRUG SUBSTANCE

DMF 150262000

IPCA LABORATORIES LTDInactiveLISINOPRIL

DMF 181042005

AUROBINDO PHARMA LTDInactiveLISINOPRIL USP

DMF 181172005

MYLAN LABORATORIES LTDInactiveLISINOPRIL USP

DMF 212062007

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

Approval Letters

21 letters from Drugs@FDA

Date	Submission	Document
Jul 25, 2017	SUPPL -76	View Letter (PDF)
Apr 22, 2016	SUPPL -74	View Letter (PDF)
Aug 27, 2015	SUPPL -73	View Letter (PDF)
Dec 30, 2014	SUPPL -64	View Letter (PDF)
Jun 27, 2014	SUPPL -57	View Letter (PDF)
Nov 7, 2013	SUPPL -63	View Letter (PDF)
Nov 5, 2012	SUPPL -61	View Letter (PDF)
Aug 16, 2012	SUPPL -62	View Letter (PDF)
May 4, 2012	SUPPL -59	View Letter (PDF)
Apr 2, 2012	SUPPL -60	View Letter (PDF)
Aug 9, 2011	SUPPL -58	View Letter (PDF)
Jan 7, 2010	SUPPL -56	View Letter (PDF)
May 26, 2009	SUPPL -54	View Letter (PDF)
Oct 10, 2007	SUPPL -53	View Letter (PDF)
Jul 24, 2007	SUPPL -52	View Letter (PDF)
Jun 20, 2006	SUPPL -50	View Letter (PDF)
May 25, 2005	SUPPL -49	View Letter (PDF)
Apr 7, 2004	SUPPL -43	View Letter (PDF)
Jul 6, 2003	SUPPL -42	View Letter (PDF)
Jul 6, 2003	SUPPL -44	View Letter (PDF)
Feb 7, 2000	SUPPL -37	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 19, 1988

No patent or exclusivity listings for this strength.

#002 — 10MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 19, 1988

#003 — 20MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 19, 1988

#004 — 40MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 19, 1988

#005 — 2.5MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 29, 1993

#006 — 30MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jan 20, 1999