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Last Updated: February 25, 2024

Nitroglycerin - Generic Drug Details


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What are the generic drug 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
IRCCS National Neurological Institute "C. Mondino" FoundationN/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
Dr Reddys NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 208191-001 Aug 26, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-005 Apr 4, 1995 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-002 Apr 4, 1995 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
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-001 May 1, 2000 ⤷  Try a Trial ⤷  Try a Trial
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 020144-004 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
Australia 2012219925 Packaging of solid pharmaceutical preparations containing the active substance glyceryl trinitrate ⤷  Try a Trial
Spain 2672261 ⤷  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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