Viewing data from:

QBRELIS

NDA

LISINOPRIL | N208401 | AZURITY PHARMACEUTICALS INC

1 strength12 unique patents0 unique exclusivities

Patent Timeline

12 unique patents by expiration date

Active (12)TodayIPRPTAB Challenge

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Nov. 6, 2035PGR

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PTAB Proceedings

1 challenge on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
PGR2017-00039	9463183	PGR	KVK-Tech, Inc. et al.	Final Written Decision	2017-07-10	—

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
Silvergate Pharmaceuticals, Inc. v. CMP Development LLC 1:2020cv00161	D. Del.	2020-01-31	Terminated 2021-04-08	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

100 trials from ClinicalTrials.gov — 2 recruiting, 73 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
NT-proBNP Selected Prevention of Cardiac Events in Diabetic Patients NCT02817360	Phase 4	Recruiting	Martin Huelsmann	2,400	2016-02 → 2026-12
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia NCT02735707	Phase 3	Recruiting	UMC Utrecht	20,000	2016-04-11 → 2028-02
Curing Atrial Fibrillation in Heart Failure NCT00292162	N/A	Completed	NHS Greater Glasgow and Clyde	41	2007-01 → 2009-07
Lisinopril in Reducing Shortness of Breath Caused by Radiation Therapy in Patients With Lung Cancer NCT01880528	Phase 2	Completed	Mayo Clinic	23	2013-05-31 → 2019-01-29
N-of-1 Trials In Children With Hypertension NCT03461003	Phase 4	Completed	The University of Texas Health Science Center, Houston	49	2018-04-02 → 2021-05-02
A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects NCT02070510	Phase 1	Completed	Novo Nordisk A/S	52	2014-02-27 → 2014-08-20
The Effect and Safety of Lisinopril in Non-hypertensive Men With Infertility From Low Sperm Count NCT01409837	Phase 2	Completed	University Of Nigeria Teaching Hospital	33	1998-03 → 2006-12
The Vascular Effects of Carvedilol Controlled Release (CR) in Abdominally Obese Hypertensive Patients NCT00459056	Phase 3	Completed	St. Paul Heart Clinic	25	2007-04 → 2010-05
VALERIA: Valsartan in Combination With Lisinopril in Hypertensive Patients With Microalbuminuria NCT00171067	Phase 3	Completed	Novartis	134	2004-07 → 2007-05
Comparative Bioavailability Study of Lisinopril Tablets, 10 mg NCT01375244	Phase 1	Completed	Par Pharmaceutical, Inc.	36	1999-06 → 1999-10

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$4.48

per ml

Lowest NADAC/Unit

$4.48

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
52652300101QBRELIS 1 MG/ML SOLUTION	$4.48	ML	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$467.48

Highest Price

$517.85

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52652-3001-01QBRELIS 1MG/ML	$517.85	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026
52652-3001-01QBRELIS 1MG/ML	$467.48	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Qbrelis (2024)

Total Spending

$2.2M

Total Claims

1,132

Beneficiaries

247

Avg Cost/Unit

$4.22

Spending Trend

$677K(2019)→$856K(2020)→$977K(2021)→$1.1M(2022)→$1.5M(2023)→$2.2M(2024)

YoY Change:+0.6%

5yr CAGR:+3.0%

Source: CMS Medicare Part D Spending by Drug (2024). 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) · 24 use codes

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	—	—	—		—