Viewing data from:

CALAN SR

NDA

VERAPAMIL HYDROCHLORIDE | N019152 | PFIZER 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

4 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Camargo Pharmaceutical Services, LLC on behalf of Cente... FDA-2020-P-2245 · 10 docket documents Camargo Pharmaceutical Services, LLC, on behalf of Center Laboratories, Inc., filed this citizen petition requesting that the FDA determine that the discontinued formulations of CALAN (verapamil hydrochloride) 40, 80, 120, and 160 mg oral tablets under NDA 018817 from Pfizer Inc were not discontinue	505(q)	2020-12-01	Granted	Center Laboratories, Inc.
Citizen Petition from Camargo Pharmaceutical Services, LLC on behalf of Cente... FDA-2020-P-2244 · 11 docket documents Camargo Pharmaceutical Services, LLC, on behalf of Center Laboratories, Inc., filed this citizen petition requesting that the FDA determine the discontinued formulations of ISOPTIN (verapamil hydrochloride) 40, 80, and 120 mg oral tablets under NDA 018593 from Mt. Adams Technologies LLC were not dis	505(q)	2020-12-01	Denied	Center Laboratories, Inc.
Citizen Petition from Heritage Pharma, Inc. FDA-2016-P-2674 · 4 docket documents Heritage Pharma, Inc., acting as the U.S. agent for Emcure Pharmaceuticals Limited, filed this citizen petition on August 31, 2016, requesting that the FDA determine that Pfizer's discontinuation of CALAN SR 180 mg Tablets (NDA 019152) was not due to safety and efficacy reasons, to permit Emcure to	505(q)	2016-09-09	Denied	Heritage Pharma, Inc.
Citizen Petition from Heritage Pharma Labs Inc FDA-2015-P-2141 · 4 docket documents Heritage Pharma Labs Inc filed this citizen petition under 21 U.S.C. § 355(j)(2)(c) requesting that the FDA immediately designate an alternative reference listed drug for verapamil hydrochloride extended release tablets 180 mg to replace the currently designated RLD, CALAN SR 180 mg, due to its unav	505(q)	2015-06-15	Open	Heritage Pharma Labs Inc

Source: Regulations.gov. FDA citizen petitions matched by application number.

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.

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

9 letters from Drugs@FDA

Date	Submission	Document
Mar 19, 2021	SUPPL -45	View Letter (PDF)
Oct 29, 2019	SUPPL -44	View Letter (PDF)
Sep 19, 2017	SUPPL -41	View Letter (PDF)
Aug 24, 2016	SUPPL -39	View Letter (PDF)
Oct 28, 2013	SUPPL -38	View Letter (PDF)
Dec 5, 2011	SUPPL -35	View Letter (PDF)
Apr 2, 2010	SUPPL -33	View Letter (PDF)
Jul 8, 2009	SUPPL -32	View Letter (PDF)
Nov 26, 2002	SUPPL -30	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 16, 1986

No patent or exclusivity listings for this strength.

#002 — 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Dec 15, 1989

#003 — 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Mar 6, 1991