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NITROLINGUAL

NDA

NITROGLYCERIN | N018705 | POHL BOSKAMP

2 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

Today

7872049

Mar. 12, 2029

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

97 trials from ClinicalTrials.gov — 3 recruiting, 2 active, 66 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Nitric Oxide Bioavailability and Early Life Stress (NO-Stress)NCT02115724	N/A	Active	Augusta University	74	2014-04 → 2027-01
Role of Sympathetic Activity and Splanchnic Capacitance in Hypertension NCT02425566	Phase 1	Active	Vanderbilt University	12	2015-04 → 2028-08
A Study to Learn About How Safe Nitroglycerin is and How it Affects the Body When Taken Along With Nurandociguat in People With Coronary Artery Disease NCT07431294	Phase 1	Not Yet Recruiting	Bayer	36	2026-10-01 → 2027-05-07
EIT Evaluation of Different Antihypertensive Agents on the Ventilation-Perfusion Ratio in Patients With Acute Respiratory Failure NCT07603037	N/A	Not Yet Recruiting	First Affiliated Hospital of Wannan Medical College	12	2026-07-15 → 2027-07-30
Utilize Imaging to Assess Changes in Hepatocellular Carcinoma Perfusion as Potentiated by Intra-Arterial Nitroglycerin NCT07682454	Phase 2	Not Yet Recruiting	University of California, San Francisco	50	2026-08-01 → 2030-02-01
Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy NCT00842023	Phase 4	Completed	Western University of Health Sciences	89	2006-07 → 2009-02
Safety and Effectiveness of Novel Nitroglycerin Based Catheter Lock Solution NCT02577718	Phase 1/2	Completed	Novel Anti-Infective Technologies, LLC	60	2015-11 → 2016-10
Effect of Nitric Oxide Donors on Uterine and Subendometrial Blood Flow in Patients With Unexplained Infertility NCT03481582	N/A	Completed	Ain Shams University	60	2017-11-01 → 2018-03-01
The Nitrate and Bone Study: Effects of Nitrates on Osteoporosis NCT00252421	Phase 3	Completed	University of Toronto	243	2005-10 → 2010-07
The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure NCT00953303	Phase 2/3	Completed	Hebei Medical University	102	2009-01 → 2012-01

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 4 NDCs

Highest NADAC/Unit

$23.80

per gm

Lowest NADAC/Unit

$15.41

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66993024150NITROGLYCERIN 400 MCG SPRAY	$23.80	GM	Generic	—	2026-08-19
28595012049NITROGLYCERIN 400 MCG SPRAY	$23.80	GM	Generic	—	2026-08-19
66993024141NITROGLYCERIN 400 MCG SPRAY	$15.41	GM	Generic	—	2026-08-19
28595012012NITROGLYCERIN 400 MCG SPRAY	$15.41	GM	Generic	—	2026-08-19

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 Big4)

Lowest Price

$42.26

Highest Price

$415.64

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
21724-0100-41NITROLINGUAL 0.4MG/SPRAY AEROSOL	$312.70	Big4	Prasco, LLC	06/30/2026
21724-0100-41NITROLINGUAL 0.4MG/SPRAY AEROSOL	$415.64	FSS	Prasco, LLC	06/30/2026
21724-0100-50NITROLINGUAL 0.4MG/SPRAY AEROSOL	$214.16	Big4	Prasco, LLC	06/30/2026
21724-0100-50NITROLINGUAL 0.4MG/SPRAY AEROSOL	$284.66	FSS	Prasco, LLC	06/30/2026
66993-0241-41NITROGLYCERIN 0.4MG/SPRAY AEROSOL	$60.05	Big4	Prasco, LLC	06/30/2026
66993-0241-41NITROGLYCERIN 0.4MG/SPRAY AEROSOL	$159.79	FSS	Prasco, LLC	06/30/2026
66993-0241-50NITROGLYCERIN 0.4MG/SPRAY AEROSOL	$42.26	Big4	Prasco, LLC	06/30/2026
66993-0241-50NITROGLYCERIN 0.4MG/SPRAY AEROSOL	$129.64	FSS	Prasco, LLC	06/30/2026

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

Medicare Part D Spending

CMS annual spending data for Nitrolingual (2024)

Total Spending

$27K

Total Claims

Beneficiaries

Avg Cost/Unit

$33.67

Spending Trend

$30K(2021)→$31K(2022)→$36K(2023)→$27K(2024)

YoY Change:-1.5%

5yr CAGR:-1.4%

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

7 letters from Drugs@FDA

Date	Submission	Document
Jul 30, 2018	SUPPL -25	View Letter (PDF)
Jan 26, 2015	SUPPL -19	View Letter (PDF)
Oct 6, 2008	SUPPL -17	View Letter (PDF)
Oct 2, 2006	SUPPL -16	View Letter (PDF)
Feb 22, 2006	SUPPL -15	View Letter (PDF)
Sep 3, 2004	SUPPL -13	View Letter (PDF)
Nov 5, 2002	SUPPL -12	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 0.4MG/SPRAY

0 patents0 exclusivities▴

AEROSOL;SUBLINGUAL | Approved: Oct 31, 1985

No patent or exclusivity listings for this strength.

#002 — 0.4MG/SPRAY

RLDAB

1 patent0 exclusivities▾

SPRAY, METERED;SUBLINGUAL | Approved: Jan 10, 1997