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Last Updated: October 1, 2022

Nitroglycerin - Generic Drug Details


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What are the generic drug sources for nitroglycerin and what is the scope of freedom to operate?

Nitroglycerin is the generic ingredient in sixteen branded drugs marketed by Evus, Pohl Boskamp, Bausch, Valeant Pharms, Valeant Pharms North, Uspharma, Hercon Pharm, Lannett Co Inc, Mylan Technologies, Novartis, Sanofi Aventis Us, Abraxis Pharm, Am Regent, Hospira, Intl Medication, Luitpold, Smith And Nephew, Baxter Hlthcare, Rorer, Parke Davis, Allergan, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Alvogen, Dr Reddys, Glenmark Pharms Sa, Rubicon, Sigmapharm Labs Llc, Zydus Pharms, and Viatris, and is included in forty-eight 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-one patent family members in ten countries.

There are thirty-six drug master file entries for nitroglycerin. Twenty-seven 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 Colorado, DenverPhase 2
Minia UniversityPhase 1/Phase 2
Thomas Jefferson UniversityEarly Phase 1

See all nitroglycerin clinical trials

Generic filers with tentative approvals for NITROGLYCERIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing0.2MG/HRFilm, Extended Release; Transdermal
See Plans and PricingSee Plans and Pricing0.4MG/HRFilm, Extended Release; Transdermal
See Plans and PricingSee Plans and Pricing0.6MG/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 Effect Vasodilation
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
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-003 May 1, 2000 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pohl Boskamp NITROLINGUAL nitroglycerin AEROSOL;SUBLINGUAL 018705-001 Oct 31, 1985 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-001 May 1, 2000 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 020144-005 Feb 27, 1996 See Plans and Pricing See Plans and Pricing
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-003 Feb 27, 1996 See Plans and Pricing See Plans and Pricing
Evus NITROMIST nitroglycerin AEROSOL, METERED;SUBLINGUAL 021780-001 Nov 2, 2006 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for nitroglycerin

Country Patent Number Title Estimated Expiration
European Patent Office 2254552 PRÉPARATION PHARMACEUTIQUE À GRANDE STABILITÉ, CONTENANT LE PRINCIPE ACTIF TRINITRATE DE GLYCÉROL (LONG-TERM STABLE PHARMACEUTICAL PREPARATION HAVING THE ACTIVE INGREDIENT GLYCEROL TRINITRATE) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2009112258 See Plans and Pricing
Australia 2012219925 Packaging of solid pharmaceutical preparations containing the active substance glyceryl trinitrate See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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