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Last Updated: November 2, 2024

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, 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, Cosette, Abbvie, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Aurobindo Pharma, Dr Reddys, Glenmark Speclt, Mankind Pharma, Natco, Rubicon, Sigmapharm Labs Llc, and Viatris, and is included in fifty-one 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-three suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for nitroglycerin
International Patents:20
US Patents:2
Tradenames:16
Applicants:33
NDAs:51
Drug Master File Entries: 36
Finished Product Suppliers / Packagers: 33
Raw Ingredient (Bulk) Api Vendors: 36
Clinical Trials: 188
Patent Applications: 6,656
Drug Prices: Drug price trends for nitroglycerin
What excipients (inactive ingredients) are in nitroglycerin?nitroglycerin excipients list
DailyMed Link:nitroglycerin at DailyMed
Drug Prices for nitroglycerin

See drug prices for nitroglycerin

Drug Sales Revenue Trends for nitroglycerin

See drug sales revenues for nitroglycerin

Recent Clinical Trials for nitroglycerin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alexandria UniversityPhase 2/Phase 3
Xuzhou Central HospitalN/A
University of Alabama at BirminghamEarly Phase 1

See all nitroglycerin clinical trials

Generic filers with tentative approvals for NITROGLYCERIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up0.2MG/HRFilm, Extended Release; Transdermal
⤷  Sign Up⤷  Sign Up0.4MG/HRFilm, Extended Release; Transdermal
⤷  Sign Up⤷  Sign Up0.6MG/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
Mankind Pharma NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 217970-002 Dec 5, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Lannett Co Inc NITROGLYCERIN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 075115-002 Aug 10, 2004 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Technologies NITROGLYCERIN nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 074992-004 Nov 12, 1999 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us NITRO-BID nitroglycerin INJECTABLE;INJECTION 018621-001 Jan 5, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-003 Apr 4, 1995 ⤷  Sign Up ⤷  Sign Up
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-002 Feb 27, 1996 ⤷  Sign Up ⤷  Sign Up
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-005 Feb 27, 1996 ⤷  Sign Up ⤷  Sign Up
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-001 May 1, 2000 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for nitroglycerin

Country Patent Number Title Estimated Expiration
Canada 2827716 GRANULES STABILISES CONTENANT DU TRINITRATE DE GLYCERYLE (STABILIZED GRANULES CONTAINING GLYCERYL TRINITRATE) ⤷  Sign Up
Spain 2565632 ⤷  Sign Up
Russian Federation 2010142023 ДЛИТЕЛЬНО СТАБИЛЬНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ С АКТИВНЫМ ВЕЩЕСТВОМ ГЛИЦЕРОЛ ТРИНИТРАТОМ ⤷  Sign Up
Poland 2678006 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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