Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Qbrelis (2023)

Total Spending

$1.5M

Total Claims

883

Beneficiaries

204

Avg Cost/Unit

$4.19

Spending Trend

$677K(2019)→$856K(2020)→$977K(2021)→$1.1M(2022)→$1.5M(2023)

YoY Change:+10.8%

5yr CAGR:+5.3%

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

2 letters from Drugs@FDA

Date	Submission	Document
Aug 2, 2017	SUPPL -2	View Letter (PDF)
Aug 2, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/ML

RLD

12 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Jul 29, 2016

Patents (12)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9463183	Nov 6, 2035	—	—	Yes	—	—
9616096	Nov 6, 2035	—	—	—		—
9814751	Nov 6, 2035	—	—	Yes	—	—
10039800	Nov 6, 2035	—	—	—		—
10265370	Nov 6, 2035	—	—	Yes	—	—
10406199	Nov 6, 2035	—	—	—		—
10940177	Nov 6, 2035	—	—	Yes	—	—
11179434	Nov 6, 2035	—	—	Yes	—	—
11771733	Nov 6, 2035	—	—	Yes	—	—
12128083	Nov 6, 2035	—	—	Yes	—	—
12186360	Nov 6, 2035	—	—	Yes	—	—
12433931	Nov 6, 2035	—	—	—		—