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Last Updated: July 29, 2021

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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, 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, Perrigo Israel, Actavis Labs Fl Inc, Alvogen, Dr Reddys, Glenmark Pharms Sa, Rubicon, Sigmapharm Labs Llc, and Upjohn, and is included in forty-seven 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-nine 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
Komar University of Science and TechnologyPhase 1/Phase 2
Aristotle University Of ThessalonikiPhase 3
424 General Military HospitalPhase 3

See all NITROGLYCERIN clinical trials

Generic filers with tentative approvals for NITROGLYCERIN
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free0.2MG/HRFilm, Extended Release; Transdermal
⤷  Try it Free⤷  Try it Free0.4MG/HRFilm, Extended Release; Transdermal
⤷  Try it Free⤷  Try it Free0.6MG/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 NDA Submissiondate
NITROLINGUAL PUMPSPRAY SPRAY, METERED;SUBLINGUAL nitroglycerin 018705 2012-04-17
NITROLINGUAL AEROSOL;SUBLINGUAL nitroglycerin 018705 2012-04-17
NITROSTAT TABLET;SUBLINGUAL nitroglycerin 021134 2005-10-19
TRANSDERM-NITRO FILM, EXTENDED RELEASE;TRANSDERMAL nitroglycerin 020144
NITRO-DUR FILM, EXTENDED RELEASE;TRANSDERMAL nitroglycerin 020145

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
Valeant Pharms MINITRAN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 089774-001 Aug 30, 1996 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-001 Apr 4, 1995 BX RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Pohl Boskamp NITROLINGUAL nitroglycerin AEROSOL;SUBLINGUAL 018705-001 Oct 31, 1985 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Labs Fl Inc NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 203693-002 Oct 16, 2017 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Actavis Labs Fl Inc NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 203693-001 Oct 16, 2017 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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
Upjohn NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-002 May 1, 2000 ⤷  Try it Free ⤷  Try it Free
Upjohn NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-003 May 1, 2000 ⤷  Try it Free ⤷  Try it Free
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-005 Apr 4, 1995 ⤷  Try it Free ⤷  Try it Free
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-002 Feb 27, 1996 ⤷  Try it Free ⤷  Try it Free
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-005 Feb 27, 1996 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Moodys
Boehringer Ingelheim
Baxter
Colorcon

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