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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

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 | 8 NDCs

Highest NADAC/Unit

$8.05

per ea

Lowest NADAC/Unit

$1.14

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00591288601VERAPAMIL SR 360 MG CAPSULE	$8.05	EA	Generic	—	2026-06-17
52536088601VERAPAMIL SR 360 MG CAPSULE	$8.05	EA	Generic	—	2026-06-17
00591288001VERAPAMIL SR 120 MG CAPSULE	$1.30	EA	Generic	—	2026-06-17
52536088001VERAPAMIL SR 120 MG CAPSULE	$1.30	EA	Generic	—	2026-06-17
52536088201VERAPAMIL SR 180 MG CAPSULE	$1.15	EA	Generic	—	2026-06-17
00591288201VERAPAMIL SR 180 MG CAPSULE	$1.15	EA	Generic	—	2026-06-17
52536088401VERAPAMIL SR 240 MG CAPSULE	$1.14	EA	Generic	—	2026-06-17
00591288401VERAPAMIL SR 240 MG CAPSULE	$1.14	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 | 12 NDCs (8 FSS, 4 Big4)

Lowest Price

$55.24

Highest Price

$433.26

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00591-2880-01VERAPAMIL HCL 120MG CAP,SA	$79.65	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00591-2880-01VERAPAMIL HCL 120MG CAP,SA	$55.24	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
00591-2882-01VERAPAMIL HCL 180MG CAP,SA	$83.33	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00591-2882-01VERAPAMIL HCL 180MG CAP,SA	$58.80	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026
00591-2884-01VERAPAMIL HCL 240MG CAP,SA	$94.15	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00591-2884-01VERAPAMIL HCL 240MG CAP,SA	$63.74	Big4	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