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VERELAN

NDA

VERAPAMIL HYDROCHLORIDE | N019614 | AZURITY PHARMACEUTICALS INC

4 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

69 trials from ClinicalTrials.gov — 4 recruiting, 1 active, 50 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Series of Pilot Studies to Evaluate the haemoDynamic and mEtabolic Effects oF apelIn aNd rElaxin NCT03449251	Phase 2	Active	Cambridge University Hospitals NHS Foundation Trust	170	2018-03-28 → 2026-12
Drug-drug Interactions Studies of VC005 Tablets in Healthy Adult Subjects NCT07796191	Phase 1	Not Yet Recruiting	Jiangsu vcare pharmaceutical technology co., LTD	84	2026-09-20 → 2026-11-30
Comparing Two Heart Medicines for Fast, Irregular Heartbeat (Atrial Fibrillation)NCT07706075	Phase 4	Not Yet Recruiting	Muhammad Ali Javed	120	2027-01-01 → 2027-08-01
Verapamil Effect in Cystic Fibrosis-related Dysglycemia NCT07688070	Phase 2	Not Yet Recruiting	Rhode Island Hospital	30	2026-08-01 → 2028-08-31
Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions NCT03218137	Phase 4	Recruiting	Weill Medical College of Cornell University	100	2017-02-13 → 2027-12-31
Nebulized Verapamil in COPD Exacerbations NCT07866989	N/A	Completed	Ain Shams University	60	2023-04-30 → 2024-03-30
The EPIVER Randomized Controlled Trial NCT04573751	N/A	Completed	Tomsk National Research Medical Center of the Russian Academy of Sciences	104	2020-12-30 → 2024-01-31
Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)NCT00000556	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1995-03 → 2002-09
Drug Discrimination in Methadone-Maintained Humans Study 2 NCT00733239	Phase 1	Completed	University of Arkansas	15	2008-08 → 2010-10
Brentuximab Vedotin, Cyclosporine, and Verapamil Hydrochloride in Treating Patients With Relapsed or Refractory Hodgkin Lymphoma NCT03013933	Phase 1	Completed	City of Hope Medical Center	29	2017-05-03 → 2022-05-24

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 4 NDCs

Highest NADAC/Unit

$7.61

per ea

Lowest NADAC/Unit

$2.83

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
52536088601VERAPAMIL SR 360 MG CAPSULE	$7.61	EA	Generic	—	2026-10-21
52536088401VERAPAMIL SR 240 MG CAPSULE	$3.43	EA	Generic	—	2026-10-21
52536088001VERAPAMIL SR 120 MG CAPSULE	$2.92	EA	Generic	—	2026-10-21
52536088201VERAPAMIL SR 180 MG CAPSULE	$2.83	EA	Generic	—	2026-10-21

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

VA Federal Supply Schedule

Government-negotiated contract prices | 12 NDCs (8 FSS, 4 Big4)

Lowest Price

$55.24

Highest Price

$433.26

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52536-0880-01VERAPAMIL HCL 120MG CAP,SA	$176.63	FSS	Wilshire Pharmaceuticals, Inc.	06/30/2026
52536-0882-01VERAPAMIL HCL 180MG CAP,SA	$187.69	FSS	Wilshire Pharmaceuticals, Inc.	06/30/2026
52536-0884-01VERAPAMIL HCL 240MG CAP,SA	$211.81	FSS	Wilshire Pharmaceuticals, Inc.	06/30/2026
52536-0886-01VERAPAMIL HCL 360MG CAP,SA	$433.26	FSS	Wilshire Pharmaceuticals, Inc.	06/30/2026
00591-2880-01VERAPAMIL HCL 120MG CAP,SA	$55.24	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
00591-2880-01VERAPAMIL HCL 120MG CAP,SA	$79.65	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026

Showing 6 of 12 NDCs.

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

API Supply Chain9 active DMFs8 inactive

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

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAVERAPAMIL HYDROCHLORIDE

DMF 48021983

ABBOTT LABORATORIESVERAPAMIL HYDROCHLORIDE

DMF 70001987

TAPI NL BVVERAPAMIL HYDROCHLORIDE

DMF 86711990

PIRAMAL PHARMA LTDVERAPAMIL HYDROCHLORIDE

DMF 166052003

MATRIX PHARMACORP PRIVATE LTDVERAPAMIL HYDROCHLORIDE USP

DMF 322932017

AURORE LIFE SCIENCES PRIVATE LTDVERAPAMIL HYDROCHLORIDE USP

DMF 340432019

COHANCE LIFESCIENCES LTDVERAPAMIL HYDROCHLORIDE USP

DMF 343412019

ALIVUS LIFE SCIENCES LTDVERAPAMIL HYDROCHLORIDE USP

DMF 356912021

DASAMI LAB PRIVATE LTDVERAPAMIL HYDROCHLORIDE USP

DMF 368082022

FINE CHEMICALS CORPInactiveVERAPAMIL HYDROCHLORIDE

DMF 51411983

GANES CHEMICALS INC PENNSVILLE DIVInactiveVERAPAMIL HYDROCHLORIDE

DMF 52271983

SELOC AGInactiveVERAPAMIL HYDROCHLORIDE

DMF 55641984

CHINOIN PHARMACEUTCIAL AND CHEMICAL WORKS CO LTDInactiveVERAPAMIL HYDROCHLORIDE

DMF 62081986

SIBEFAT SPAInactiveVERAPAMIL HYDROCHLORIDE

DMF 67081986

ALFA CHEMICALS ITALIANA SRLInactiveVERAPAMIL HYDROCHLORIDE

DMF 72441987

CHEMISCHE FABRIK WEYL GMBHInactiveVERAPAMIL HYDROCHLORIDE

DMF 74551988

DIVIS LABORATORIES LTDInactiveVERAPAMIL HYDROCHLORIDE USP

DMF 185232005

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Oct 2, 2019	SUPPL -56	View Letter (PDF)
Nov 22, 2016	SUPPL -53	View Letter (PDF)
Oct 10, 2014	SUPPL -50	View Letter (PDF)
Nov 16, 2011	SUPPL -49	View Letter (PDF)
Apr 9, 2010	SUPPL -34	View Letter (PDF)
Apr 2, 2010	SUPPL -45	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 120MG

RLDAB

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 29, 1990

No patent or exclusivity listings for this strength.

#002 — 240MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 29, 1990

#003 — 180MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Jan 9, 1992

#004 — 360MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: May 10, 1996