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Last Updated: August 3, 2020

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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 freedom to operate?

Nitroglycerin is the generic ingredient in sixteen branded drugs marketed by Evus, Pohl Boskamp, Medicis, 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, Sigmapharm Labs Llc, and Pfizer Pharms, and is included in forty-six 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. Thirty 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
Assiut UniversityEarly Phase 1
Deborah Heart and Lung CenterEarly Phase 1
Alexandria UniversityN/A

See all nitroglycerin clinical trials

Generic filers with tentative approvals for NITROGLYCERIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.2MG/HRFilm, Extended Release; Transdermal
  Start Trial  Start Trial0.4MG/HRFilm, Extended Release; Transdermal
  Start Trial  Start 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 NDA Submissiondate
NITROLINGUAL AEROSOL;SUBLINGUAL nitroglycerin 018705 2012-04-17
NITROLINGUAL PUMPSPRAY SPRAY, METERED;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
Abraxis Pharm NITROGLYCERIN nitroglycerin INJECTABLE;INJECTION 071203-001 May 8, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Baxter Hlthcare NITROGLYCERIN IN DEXTROSE 5% nitroglycerin INJECTABLE;INJECTION 019970-003 Dec 29, 1989 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us NITRO-BID nitroglycerin INJECTABLE;INJECTION 018621-001 Jan 5, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Hercon Pharm NITROGLYCERIN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 089886-001 Oct 30, 1998 AB2 RX No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-002 Feb 27, 1996   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-005 Apr 4, 1995   Start Trial   Start Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-005 Feb 27, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Colorcon
Harvard Business School
Boehringer Ingelheim
Merck
McKesson

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