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Last Updated: December 8, 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, 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-five 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: 35
Raw Ingredient (Bulk) Api Vendors: 36
Clinical Trials: 188
Patent Applications: 6,364
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
Cosette NITROGLYCERIN nitroglycerin OINTMENT;INTRA-ANAL 216103-001 Feb 16, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Parke Davis NITROSTAT nitroglycerin INJECTABLE;INJECTION 070872-001 Jan 8, 1987 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 208191-003 Aug 26, 2016 AB RX 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
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-005 Feb 27, 1996 ⤷  Sign Up ⤷  Sign Up
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-002 May 1, 2000 ⤷  Sign Up ⤷  Sign Up
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-002 Feb 27, 1996 ⤷  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
World Intellectual Property Organization (WIPO) 2009112258 ⤷  Sign Up
Germany 202008007318 ⤷  Sign Up
Canada 2718345 PREPARATION PHARMACEUTIQUE A GRANDE STABILITE, CONTENANT LE PRINCIPE ACTIF TRINITRATE DE GLYCEROL (LONG-TERM STABLE PHARMACEUTICAL PREPARATION HAVING THE ACTIVE INGREDIENT GLYCEROL TRINITRATE) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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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.