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Last Updated: March 28, 2024

Nitroglycerin - Generic Drug Details


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What are the generic sources for nitroglycerin and what is the scope of patent protection?

Nitroglycerin is the generic ingredient in sixteen branded drugs marketed by Evus, Pohl Boskamp, Bausch, Valeant Pharms, Valeant Pharms North, Uspharma, Lannett Co Inc, Mylan Technologies, Zydus Pharms, Novartis, Sanofi Aventis Us, Abraxis Pharm, Am Regent, Hospira, Intl Medication, Luitpold, Smith And Nephew, Baxter Hlthcare, Rorer, Parke Davis, Abbvie, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Aurobindo Pharma, Dr Reddys, Glenmark Pharms Sa, Mankind Pharma, Natco, Rubicon, Sigmapharm Labs Llc, and Viatris, and is included in fifty NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Nitroglycerin has twenty patent family members in nine countries.

There are thirty-six drug master file entries for nitroglycerin. Thirty-two suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for nitroglycerin

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Drug Sales Revenue Trends for nitroglycerin

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Recent Clinical Trials for nitroglycerin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Alabama at BirminghamEarly Phase 1
Tanta UniversityN/A
Pak Emirates Military HospitalN/A

See all nitroglycerin clinical trials

Generic filers with tentative approvals for NITROGLYCERIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial0.2MG/HRFilm, Extended Release; Transdermal
⤷  Try a Trial⤷  Try a Trial0.4MG/HRFilm, Extended Release; Transdermal
⤷  Try a Trial⤷  Try a Trial0.6MG/HRFilm, Extended Release; Transdermal

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for nitroglycerin
Drug ClassNitrate Vasodilator
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for nitroglycerin
Paragraph IV (Patent) Challenges for NITROGLYCERIN
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NITROLINGUAL PUMPSPRAY Sublingual Spray nitroglycerin 400 mcg/spray, 4.9 g and 12 g bottles 018705 1 2012-04-17
NITROSTAT Sublingual Tablets nitroglycerin 0.3 mg, 0.4 mg, and 0.6 mg 021134 1 2005-10-19

US Patents and Regulatory Information for nitroglycerin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-004 Feb 27, 1996 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rubicon NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 209779-001 May 3, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms NITROGLYCERIN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 089886-001 Oct 30, 1998 AB2 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mankind Pharma NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 217970-003 Dec 5, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Parke Davis NITROSTAT nitroglycerin INJECTABLE;INJECTION 018588-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-002 Feb 27, 1996 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-003 May 1, 2000 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for nitroglycerin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-003 Feb 27, 1996 ⤷  Try a Trial ⤷  Try a Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-005 Feb 27, 1996 ⤷  Try a Trial ⤷  Try a Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-002 Feb 27, 1996 ⤷  Try a Trial ⤷  Try a Trial
Evus NITROMIST nitroglycerin AEROSOL, METERED;SUBLINGUAL 021780-001 Nov 2, 2006 ⤷  Try a Trial ⤷  Try a Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-001 Feb 27, 1996 ⤷  Try a Trial ⤷  Try a Trial
Pohl Boskamp NITROLINGUAL PUMPSPRAY nitroglycerin SPRAY, METERED;SUBLINGUAL 018705-002 Jan 10, 1997 ⤷  Try a Trial ⤷  Try a Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-002 Feb 27, 1996 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for nitroglycerin

Country Patent Number Title Estimated Expiration
Poland 2678006 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2012113564 ⤷  Try a Trial
European Patent Office 2678006 CONDITIONNEMENT DE PRÉPARATIONS PHARMACEUTIQUES SOLIDES CONTENANT LA SUBSTANCE ACTIVE TRINITRATE DE GLYCÉRYLE (PACKAGING OF SOLID PHARMACEUTICAL PREPARATIONS CONTAINING THE ACTIVE SUBSTANCE GLYCERYL TRINITRATE) ⤷  Try a Trial
Spain 2565632 ⤷  Try a Trial
Germany 202008007318 ⤷  Try a Trial
Brazil PI0908577 preparação farmacêutica estável por longo tempo com a substância ativa trinitrato de glicerol ⤷  Try a Trial
European Patent Office 2678000 GRANULES STABILISÉS CONTENANT DU TRINITRATE DE GLYCÉRYLE (STABILIZED GRANULES CONTAINING GLYCERYL TRINITRATE) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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