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NITRO-DUR

NDA

NITROGLYCERIN | N020145 | USPHARMA LTD

6 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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizens Petition from Hercon Laboratories Corporation FDA-1995-P-0278 · 4 docket documents Hercon Laboratories Corporation filed this citizen petition under Section 505(j)(6) requesting that upon FDA approval of an ANDA or 505(b)(2) application for a generic transdermal nitroglycerin patch bioequivalent to Summit Pharmaceuticals' Transderm-Nitro®, the agency clearly designate such generic	505(q)	2009-06-04	Granted	Hercon Laboratories Corporation
Citizen Petition from Schering-Plough Corporation FDA-1995-P-0140 · 4 docket documents Schering-Plough Corporation filed this Section 505(j) citizen petition requesting that the FDA evaluate only those transdermal nitroglycerin patch products meeting all criteria for therapeutic equivalence, including pharmaceutical equivalence, as therapeutic equivalents of Nitro-Dur, and requesting	505(q)	2009-06-04	Denied	Schering-Plough Corporation

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

Clinical Trials

94 trials from ClinicalTrials.gov, 2 active, 66 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Role of Sympathetic Activity and Splanchnic Capacitance in Hypertension NCT02425566	Phase 1	Active	Vanderbilt University	12	2015-04 → 2026-08
Nitric Oxide Bioavailability and Early Life Stress (NO-Stress)NCT02115724	N/A	Active	Augusta University	74	2014-04 → 2027-01
Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.NCT00431691	Phase 4	Completed	Medical University of Vienna	22	2006-09 → 2007-12
Topical Radial Artery Vasodilation NCT01155167	Phase 2/3	Completed	University of California, San Francisco	86	2010-07 → 2012-08
Phase III Study of a Topical Gel Formulation for Treatment and Prevention of Raynaud's Phenomenon NCT00419419	Phase 3	Completed	MediQuest Therapeutics	80	2006-12
Effect of Hypotensive Anesthesia on the Perfusion Index NCT03059316	Early Phase 1	Completed	Cairo University	40	2016-06-10 → 2017-04-21
Diltiazem Gel Versus Nitroglycerin Ointment in Healing Process of Scleroderma Digital Ulcers NCT02801305	Phase 2	Completed	Mohammad Ali Nazarinia	90	2016-06 → 2017-03
The Mechanisms of Diameter Changes in Retinal Vessels During Hypoxia NCT02059018	N/A	Completed	University of Aarhus	20	2014-02 → 2015-08
A Study to Determine the Effect of Nitroglycerin Ointment 0.4% (Cellegesic) on the Pain Associated With Chronic Anal Fissures NCT00522041	Phase 3	Completed	Forest Laboratories	248	2007-08 → 2008-07
Goal-directed Afterload Reduction in Acute Congestive Cardiac Decompensation Study NCT00512759	Phase 4	Completed	University Hospital, Basel, Switzerland	781	2007-12-10 → 2019-02-21

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 5 NDCs (1 brand, 4 generic)

Highest NADAC/Unit

$50.44

per ea

Lowest NADAC/Unit

$0.4851

per ea

Brand NDCs

Generic NDCs

Avg Brand: $50.44

Avg Generic: $0.6888

99% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
50742051530NITRO-DUR 0.3 MG/HR PATCH	$50.44	EA	Brand	—	2026-06-17
43598089330NITROGLYCERIN 0.6 MG/HR PATCH	$0.9486	EA	Generic	—	2026-06-17
43598089430NITROGLYCERIN 0.4 MG/HR PATCH	$0.7047	EA	Generic	—	2026-06-17
43598089530NITROGLYCERIN 0.2 MG/HR PATCH	$0.6167	EA	Generic	—	2026-06-17
43598089630NITROGLYCERIN 0.1 MG/HR PATCH	$0.4851	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 | 8 NDCs (4 FSS, 4 NC)

Lowest Price

$7.82

Highest Price

$29.98

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
43598-0893-30NITROGLYCERIN 0.6MG/HR PATCH	$29.98	FSS	Dr. Reddys Laboratories	09/14/2026
43598-0893-30NITROGLYCERIN 0.6MG/HR PATCH	$14.80	NC	Dr. Reddy's Laboratories, Inc.	07/08/2026
43598-0896-30NITROGLYCERIN 0.1MG/HR PATCH	$18.46	FSS	Dr. Reddys Laboratories	09/14/2026
43598-0896-30NITROGLYCERIN 0.1MG/HR PATCH	$7.82	NC	Dr. Reddy's Laboratories, Inc.	07/08/2026
43598-0894-30NITROGLYCERIN 0.4MG/HR PATCH	$28.11	FSS	Dr. Reddys Laboratories	09/14/2026
43598-0894-30NITROGLYCERIN 0.4MG/HR PATCH	$10.75	NC	Dr. Reddy's Laboratories, Inc.	07/08/2026
43598-0895-30NITROGLYCERIN 0.2MG/HR PATCH	$25.01	FSS	Dr. Reddys Laboratories	09/14/2026
43598-0895-30NITROGLYCERIN 0.2MG/HR PATCH	$8.93	NC	Dr. Reddy's Laboratories, Inc.	07/08/2026

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

Medicare Part D Spending

CMS annual spending data for Nitro-Dur (2024)

Total Spending

$2.7M

Total Claims

1,298

Beneficiaries

419

Avg Cost/Unit

$50.83

Spending Trend

$2.5M(2019)→$3.5M(2020)→$4.0M(2021)→$3.4M(2022)→$3.5M(2023)→$2.7M(2024)

YoY Change:-2.9%

5yr CAGR:+16.7%

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

API Supply Chain3 active DMFs4 inactive

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

DYNAMIT NOBEL GMBH EXPLOSIVSTOFF UND SYSTEMTECHNIKNITROGLYCERIN

DMF 85241990

COPPERHEAD INVESTMENTS INCNITROGLYCERIN

DMF 115951995

BHARAT PHARMA (A UNIT OF BHARAT EXPLOSIVES LTD)NITROGLYCERIN AS IN DILUTED NITROGLYCERIN, USP

DMF 224352009

VICTOR M HERMELIN CO DIV K-V PHARMACAL COInactiveNITROGLYCERIN

DMF 9781966

ELI LILLY AND COInactiveNITROGLYCERIN AMPOULES

DMF 19231972

SOCIETE SUISSE DES EXPLOSIFSInactiveNITROGLYCERIN,PENTAERYTHRITOL TETRANITRATE AND ISOSORBIDE DINITRATE

DMF 45041982

DYNAMIT NOBEL AGInactiveNITROGLYCERIN 5% IN MIGLYOL 829

DMF 68471987

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Oct 3, 2014	SUPPL -27	View Letter (PDF)
Apr 12, 2005	SUPPL -21	View Letter (PDF)
Jun 25, 2004	SUPPL -15	View Letter (PDF)
Oct 18, 2002	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (6)

Sort:

#001 — 0.1MG/HR

RLD

0 patents0 exclusivities▴