Viewing data from:

VERELAN PM

NDA

VERAPAMIL HYDROCHLORIDE | N020943 | AZURITY PHARMACEUTICALS INC

3 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

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

63 trials from ClinicalTrials.gov — 1 recruiting, 48 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)NCT00000556	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)	—	1995-03 → 2002-09
Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers NCT01197781	Phase 1	Completed	AstraZeneca	15	2010-09 → 2010-10
Russian Study of the Efficacy and Safety of Tarka in Patients With Hypertension NCT00235001	Phase 4	Completed	Abbott	120	2004-06
Drug-Drug Interaction Between Colchicine and Verapamil ER NCT00983242	Phase 1	Completed	Mutual Pharmaceutical Company, Inc.	24	2008-09 → 2008-10
A Study to Evaluate Whether Verapamil Has an Effect on the Uptake and Elimination of Solifenacin and Tamsulosin When Administered in a Combination Tablet NCT01943487	Phase 1	Completed	Astellas Pharma Europe B.V.	36	2009-08 → 2009-12
A Phase I Study to Assess PK of AZD7986 Alone & With Verapamil, Itraconazole or Diltiazem in Healthy Subjects NCT02653872	Phase 1	Completed	AstraZeneca	15	2016-01-22 → 2016-04-13
CiPA Phase 1 ECG Biomarker Validation Study NCT03070470	Phase 1	Completed	Food and Drug Administration (FDA)	60	2017-03-14 → 2017-06-26
A Study to Learn About the Drug-drug Interactions of Sisunatovir in Healthy Adult Participants NCT03782662	Phase 1	Completed	Pfizer	82	2018-11-07 → 2019-03-17
Effects of Different Vasodilators on Coronary No-reflow During primAry percuTaneous Coronary intErvention in Patients With Acute Myocardial Infarction NCT00712894	Phase 4	Completed	Fudan University	102	2006-12 → 2009-08

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 7 NDCs

Highest NADAC/Unit

$8.03

per ea

Lowest NADAC/Unit

$4.07

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
52536048737VERAPAMIL ER PM 300 MG CAPSULE	$8.03	EA	Generic	—	2026-06-17
62175048737VERAPAMIL ER PM 300 MG CAPSULE	$8.03	EA	Generic	—	2026-06-17
62175048637VERAPAMIL ER PM 200 MG CAPSULE	$5.48	EA	Generic	—	2026-06-17
52536048637VERAPAMIL ER PM 200 MG CAPSULE	$5.48	EA	Generic	—	2026-06-17
52536048537VERAPAMIL ER PM 100 MG CAPSULE	$4.07	EA	Generic	—	2026-06-17
62135053230VERAPAMIL ER PM 100 MG CAPSULE	$4.07	EA	Generic	—	2026-06-17
62175048537VERAPAMIL ER PM 100 MG CAPSULE	$4.07	EA	Generic	—	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 | 9 NDCs (9 FSS)

Lowest Price

$105.50

Highest Price

$459.84

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
52536-0485-37VERAPAMIL HCL 100MG CAP,SA	$244.17	FSS	Wilshire Pharmaceuticals, Inc.	06/30/2026
52536-0486-37VERAPAMIL HCL 200MG CAP,SA	$311.25	FSS	Wilshire Pharmaceuticals, Inc.	06/30/2026
62175-0485-37VERAPAMIL HCL 100MG CAP,SA	$105.50	FSS	Kremers Urban Pharmaceuticals, Inc.	08/31/2026
62175-0486-37VERAPAMIL HCL 200MG CAP,SA	$151.19	FSS	Kremers Urban Pharmaceuticals, Inc.	08/31/2026
62175-0570-37VERELAN PM ER 100MG	$183.81	FSS	Kremers Urban Pharmaceuticals, Inc.	08/31/2026
62175-0487-37VERAPAMIL HCL 300MG CAP,SA	$214.74	FSS	Kremers Urban Pharmaceuticals, Inc.	08/31/2026

Showing 6 of 9 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Verelan PM (2024)

Total Spending

$110K

Total Claims

230

Beneficiaries

Avg Cost/Unit

$6.95

Spending Trend

$201K(2019)→$178K(2020)→$153K(2021)→$138K(2022)→$120K(2023)→$110K(2024)

YoY Change:+1.9%

5yr CAGR:+1.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

10 letters from Drugs@FDA

Date	Submission	Document
Oct 4, 2019	SUPPL -35	View Letter (PDF)
Nov 22, 2016	SUPPL -32	View Letter (PDF)
Oct 14, 2014	SUPPL -29	View Letter (PDF)
Nov 16, 2011	SUPPL -28	View Letter (PDF)
Apr 9, 2010	SUPPL -7	View Letter (PDF)
Apr 5, 2010	SUPPL -26	View Letter (PDF)
Dec 24, 2009	SUPPL -21	View Letter (PDF)
May 7, 2007	SUPPL -20	View Letter (PDF)
May 7, 2004	SUPPL -13	View Letter (PDF)
Nov 25, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 100MG

RLD

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Nov 25, 1998

No patent or exclusivity listings for this strength.

#002 — 200MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Nov 25, 1998

#003 — 300MG

RLD

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Nov 25, 1998