Viewing data from:

NORVASC

NDA

AMLODIPINE BESYLATE | N019787 | VIATRIS SPECIALTY LLC

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

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Pfizer Inc FDA-2007-P-0350 · 6 docket documents Pfizer Inc submitted this citizen petition on March 21, 2007, requesting that the FDA rescind final approval of Novartis's NDA 20-364 for Lotrel (amlodipine besylate and benazepril hydrochloride) and withhold approval of any supplemental NDAs, arguing that the Lotrel NDA should be reclassified as a	505(q)	2008-05-23	Denied	Pfizer Inc
Citizen Petition from Zydus Pharmaceuticals USA, Inc. FDA-2007-P-0054 · 3 docket documents Zydus Pharmaceuticals USA, Inc. filed this citizen petition on April 3, 2007, requesting that the FDA oppose Mylan Laboratories' application for a temporary restraining order in federal court and immediately approve all complete amlodipine besylate ANDAs then pending, arguing that Mylan's attempt to	505(q)	2008-04-11	Open	Zydus Pharmaceuticals USA, Inc.

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

Clinical Trials

429 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 351 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Intensive Management of Blood Pressure and Cholesterol in Elderly Chinese With Hypertension and Atrial Fibrillation NCT04111419	Phase 4	Active	Shanghai Jiao Tong University School of Medicine	1,200	2020-07-01 → 2026-12-31
Intervention for High-normal Blood Pressure in Adults With Type 2 Diabetes NCT03264352	Phase 4	Recruiting	XueQing Yu	11,414	2018-02-01 → 2025-09
Triple Therapy Prevention of Recurrent Intracerebral Disease EveNts Trial NCT02699645	Phase 3	Completed	The George Institute	1,671	2017-09-28 → 2025-08-27
Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg NCT01494727	Phase 1	Completed	HK inno.N Corporation	48	2012-02 → 2012-04
A Two Way Cross Over Pharmacokinetic Interaction Study Between Raltegravir and Amlodipine in Healthy Volunteers NCT01841593	Phase 1	Completed	St Stephens Aids Trust	19	2013-04 → 2013-09
Bioequivalence Study of Telmisartan/Amlodipine Fixed Dose Combination Compared With Its Monocomponents in Healthy Male and Female Volunteers NCT02259829	Phase 1	Completed	Boehringer Ingelheim	84	2007-09
Bioequivalence Study (Candesartan 16 mg and Amlodipine 5 mg) - A NCT02801526	Phase 1	Completed	Chong Kun Dang Pharmaceutical	32	2015-04 → 2015-08
Bioequivalence Trial of Concor AM® vs Bisoprolol and Amlodipine in Chinese Participants NCT03226275	Phase 1	Completed	Merck KGaA, Darmstadt, Germany	32	2017-08-09 → 2017-09-09
A Year Long Study to Evaluate the Safety of the Combination of Valsartan (320 mg) and Amlodipine (5 mg) in Patients With Hypertension NCT00170976	Phase 3	Completed	Novartis	403	2004-04 → 2005-06
Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension NCT00171054	Phase 4	Completed	Novartis	125	2003-09 → 2007-10

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 17 NDCs (10 brand, 7 generic)

Highest NADAC/Unit

$11.99

per ea

Lowest NADAC/Unit

$0.0102

per ea

Brand NDCs

Generic NDCs

Avg Brand: $9.68

Avg Generic: $0.0118

100% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00069154068NORVASC 10 MG TABLET	$11.99	EA	Brand	$0.0152	2026-06-17
58151035588NORVASC 10 MG TABLET	$11.99	EA	Brand	$0.0152	2026-06-17
58151035577NORVASC 10 MG TABLET	$11.99	EA	Brand	$0.0152	2026-06-17
58151035377NORVASC 2.5 MG TABLET	$8.70	EA	Brand	$0.0106	2026-01-01
00069152068NORVASC 2.5 MG TABLET	$8.70	EA	Brand	$0.0106	2026-01-01
00069153072NORVASC 5 MG TABLET	$8.68	EA	Brand	$0.0102	2026-06-17

Showing 6 of 17 NDCs.

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

VA Federal Supply Schedule

Government-negotiated contract prices | 32 NDCs (16 FSS, 16 Big4)

Lowest Price

$0.27

Highest Price

$1394.87

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
58151-0353-77NORVASC 2.5MG TAB	$425.10	FSS	Mylan Specialty L.P.	01/14/2027
58151-0353-77NORVASC 2.5MG TAB	$425.10	Big4	Mylan Specialty L.P.	01/14/2027
59762-2010-01AMLODIPINE BESYLATE 5MG TAB	$18.07	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-2010-01AMLODIPINE BESYLATE 5MG TAB	$10.94	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-2010-03AMLODIPINE BESYLATE 5MG TAB	$7.88	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-2010-03AMLODIPINE BESYLATE 5MG TAB	$7.88	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027

Showing 6 of 32 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Norvasc (2024)

Total Spending

$14.5M

Total Claims

20,746

Beneficiaries

5,263

Avg Cost/Unit

$9.20

Spending Trend

$24.1M(2019)→$23.7M(2020)→$18.2M(2021)→$17.1M(2022)→$16.3M(2023)→$14.5M(2024)

YoY Change:-1.4%

5yr CAGR:+4.9%

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

API Supply Chain20 active DMFs14 inactive

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

TAPI NL BVAMLODIPINE BESYLATE

DMF 157772001

CADILA PHARMACEUTICALS LTDAMLODIPINE BESYLATE USP

DMF 169112003

CIPLA LTDAMLODIPINE BESYLATE USP

DMF 170322003

HETERO DRUGS LTDAMLODIPINE BESYLATE

DMF 187872005

APITORIA PHARMA PRIVATE LTDAMLODIPINE BESYLATE USP

DMF 189652005

ORBION PHARMACEUTICALS PRIVATE LTDAMLODIPINE BESYLATE

DMF 195822006

GLOCHEM INDUSTRIES PRIVATE LTDAMLODIPINE BESYLATE

DMF 195912006

MATRIX PHARMACORP PRIVATE LTDAMLODIPINE BESYLATE USP

DMF 201122007

SRINI PHARMACEUTICALS PRIVATE LTDAMLODIPINE BESYLATE USP

DMF 226222009

ZYDUS LIFESCIENCES LTDAMLODIPINE BESYLATE USP

DMF 229302009

NOVARTIS PHARMACEUTICALS CORPAMLODIPINE BESYLATE (PROCESS 2)

DMF 229642009

IPCA LABORATORIES LTDAMLODIPINE BESYLATE USP

DMF 235892010

ARCH PHARMALABS LTDAMLODIPINE BESYLATE USP

DMF 236322010

GLOCHEM INDUSTRIES PRIVATE LTDAMLODIPINE BESYLATE (PROCESS 1)

DMF 278102013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDAMLODIPINE BESYLATE USP

DMF 288862015

ALKEM LABORATORIES LTDAMLODIPINE BESYLATE USP

DMF 297032015

AURORE LIFE SCIENCES PRIVATE LTDAMLODIPINE BESYLATE USP

DMF 343182019

ARENE LIFE SCIENCES PRIVATE LTDAMLODIPINE BESYLATE USP (PROCESS-I)

DMF 359972021

UNICHEM LABORATORIES LTDAMLODIPINE BESYLATE (ADP PROCESS) USP

DMF 404382024

LEE PHARMA LIMITEDAMLODIPINE BESYLATE

DMF 437012026

MATRIX LABORATORIES LTDInactiveAMLODIPINE

DMF 165962003

LEK PHARMACEUTICALS DDInactiveAMLODIPINE BESYLATE

DMF 168872003

MYLAN LABORATORIES LTDInactiveAMLODIPINE BESYLATE USP (ADP)

DMF 172112004

GEDEON RICHTER LTDInactiveAMLODIPINE BESYLATE

DMF 175842004

SYNTHON BVInactiveAMLODIPINE BESYLATE MONOHYDRATE

DMF 188722005

EOS ECZACIBASI OZGUN KIMYASAL URUNLER SANAYI VE TICARET ASInactiveAMLODIPINE BESYLATE

DMF 202772007

CHANGZHOU RUIMING PHARMACEUTICAL CO LTDInactiveAMLODIPINE BESYLATE (NON-STERILE DRUG SUBSTANCE)

DMF 212562008

ALP PHARM BEIJING CO LTDInactiveAMLODIPINE BESYLATE (DRUG SUBSTANCE, NON-STERILE)

DMF 219512008

ESTEVE QUIMICA SAInactiveAMLODIPINE BESYLATE

DMF 223422008

SHANDONG XINHUA PHARMACEUTICAL CO LTDInactiveAMLODIPINE BESYLATE

DMF 261322012

EGIS PHARMACEUTICALS PRIVATE LTD COInactiveAMLODIPINE BESYLATE API

DMF 279642014

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveAMLODIPINE BESYLATE (PROCESS II)

DMF 283512014

HETERO DRUGS LTDInactiveAMLODIPINE BESYLATE (PROCESS-II)

DMF 307172016

ARENE LIFE SCIENCES PVT LTDInactiveAMLODIPINE BESYLATE USP

DMF 338732019

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

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Nov 6, 2017	SUPPL -62	View Letter (PDF)
Apr 3, 2017	SUPPL -61	View Letter (PDF)
Mar 25, 2015	SUPPL -59	View Letter (PDF)
Jan 8, 2013	SUPPL -54	View Letter (PDF)
Jan 8, 2013	SUPPL -53	View Letter (PDF)
Nov 2, 2011	SUPPL -52	View Letter (PDF)
May 11, 2011	SUPPL -47	View Letter (PDF)
Feb 22, 2010	SUPPL -45	View Letter (PDF)
Nov 8, 2007	SUPPL -42	View Letter (PDF)
Oct 20, 2005	SUPPL -38	View Letter (PDF)
Jul 15, 2005	SUPPL -37	View Letter (PDF)
Jun 10, 2004	SUPPL -19	View Letter (PDF)
Jan 9, 2004	SUPPL -30	View Letter (PDF)
Dec 8, 2003	SUPPL -27	View Letter (PDF)
Aug 28, 2003	SUPPL -31	View Letter (PDF)
May 28, 2002	SUPPL -32	View Letter (PDF)
Jul 12, 2000	SUPPL -17	View Letter (PDF)
Jul 12, 2000	SUPPL -20	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 2.5MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 31, 1992

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 31, 1992

#003 — EQ 10MG BASE

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 31, 1992