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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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizens Petition from Hercon Laboratories Corporation FDA-1995-P-0278 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	Denied	Hercon Laboratories Corporation

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Nitro-Dur (2023)

Total Spending

$3.5M

Total Claims

1,560

Beneficiaries

451

Avg Cost/Unit

$52.33

Spending Trend

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

YoY Change:+10.8%

5yr CAGR:+30.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs3 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

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)

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#001 — 0.1MG/HR

RLD

0 patents0 exclusivities▴