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Last Updated: October 21, 2020

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NITROGLYCERIN Drug Profile

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Which patents cover Nitroglycerin, and what generic alternatives are available?

Nitroglycerin is a drug marketed by Hercon Pharm, Lannett Co Inc, Mylan Technologies, Abraxis Pharm, Am Regent, Hospira, Intl Medication, Luitpold, Smith And Nephew, Fougera Pharms Inc, Perrigo Israel, Actavis Labs Fl Inc, Alvogen, Dr Reddys, Glenmark Pharms Sa, Sigmapharm Labs Llc, and Baxter Hlthcare. and is included in twenty-six NDAs.

The generic ingredient in NITROGLYCERIN is nitroglycerin. There are thirty-six drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

US ANDA Litigation and Generic Entry Outlook for Nitroglycerin

A generic version of NITROGLYCERIN was approved as nitroglycerin by AM REGENT on May 24th, 1988.

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Drug patent expirations by year for NITROGLYCERIN
Drug Prices for NITROGLYCERIN

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Drug Sales Revenue Trends for NITROGLYCERIN

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Recent Clinical Trials for NITROGLYCERIN

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SponsorPhase
Assiut UniversityEarly Phase 1
Deborah Heart and Lung CenterEarly Phase 1
Alexandria UniversityN/A

See all NITROGLYCERIN clinical trials

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
NITRO-DUR FILM, EXTENDED RELEASE;TRANSDERMAL nitroglycerin 020145
TRANSDERM-NITRO FILM, EXTENDED RELEASE;TRANSDERMAL nitroglycerin 020144

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
Baxter Hlthcare NITROGLYCERIN IN DEXTROSE 5% nitroglycerin INJECTABLE;INJECTION 019970-002 Dec 29, 1989 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Dr Reddys NITROGLYCERIN nitroglycerin TABLET;SUBLINGUAL 208191-002 Aug 26, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Hospira NITROGLYCERIN IN DEXTROSE 5% nitroglycerin INJECTABLE;INJECTION 071847-001 Aug 31, 1990 DISCN 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

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