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Last Updated: December 1, 2022

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, Allergan, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Dr Reddys, Glenmark Pharms Sa, Natco, Rubicon, Sigmapharm Labs Llc, 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
Kafrelsheikh UniversityN/A
Pak Emirates Military HospitalN/A
University of Colorado, DenverPhase 2

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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
Glenmark Pharms Sa NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 206391-002 Sep 19, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abraxis Pharm NITROGLYCERIN nitroglycerin INJECTABLE;INJECTION 071203-001 May 8, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pohl Boskamp NITROLINGUAL PUMPSPRAY nitroglycerin SPRAY, METERED;SUBLINGUAL 018705-002 Jan 10, 1997 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 020144-001 Feb 27, 1996 See Plans and Pricing See Plans and Pricing
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-006 Apr 4, 1995 See Plans and Pricing See Plans and Pricing
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-003 May 1, 2000 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
Canada 2827714 CONDITIONNEMENT DE PREPARATIONS PHARMACEUTIQUES SOLIDES CONTENANT LA SUBSTANCE ACTIVE TRINITRATE DE GLYCERYLE (PACKAGING OF SOLID PHARMACEUTICAL PREPARATIONS CONTAINING THE ACTIVE SUBSTANCE GLYCERYL TRINITRATE) See Plans and Pricing
Australia 2012219926 Stabilized granules containing glyceryl trinitrate 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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Dow
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.