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Details for Generic Name: nitroglycerin

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Nitroglycerin is the generic ingredient in fifteen branded drugs marketed by Abraxis Pharm, Pohl Boskamp, Kremers Urban Pharms, Sanofi Aventis Us, Intl Medication, Hospira, Smith And Nephew, Luitpold, Pfizer Pharms, Novartis, Merck Sharp Dohme, Fougera, Mylan Technologies, Forest Labs Inc, Parke Davis, Baxter Hlthcare, Valeant Pharms, Medicis, Rorer, Mist Pharms Llc, Hercon Pharm, and Perrigo Israel, and is included in forty NDAs. There are three patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has twenty-eight patent family members in sixteen countries.

There are thirty-six drug master file entries for nitroglycerin. Eighteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: nitroglycerin

Drug Master File Entries: see list36
Suppliers / Packaging: see list57
Therapeutic Class:Cardiovascular Agents

Pharmacology for Ingredient: nitroglycerin

Drug ClassNitrate Vasodilator
Physiological EffectVasodilation

Tentative approvals for NITROGLYCERIN

Applicant Application No. Form Dosage
<disabled><disabled>Film, Extended Release; Transdermal0.2MG/HR
<disabled><disabled>Film, Extended Release; Transdermal0.4MG/HR
<disabled><disabled>Film, Extended Release; Transdermal0.6MG/HR

Clinical Trials for: nitroglycerin

Nitroglycerin in Non-small Cell Lung Cancer
Status: Recruiting Condition: Non Small Cell Lung Cancer (NSCLC)

Treatment of Suspected Cholelithiasis With Nitroglycerin
Status: Not yet recruiting Condition: COLIC; BILIARY TRACT DISEASES

Radial Artery Dilation Study: The Effect of Topical Administration of Nitroglycerin and Lidocaine Versus Lidocaine Alone of the Radial Artery Diameter
Status: Completed Condition: Healthy

MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects
Status: Completed Condition: Healthy

The Effect of Nitroglycerin on the Intrauterine Device (IUD) Insertion Experience in Nulliparous Women
Status: Recruiting Condition: Contraception; Pain

Nitroglycerin Prevents Radial Artery Occlusion
Status: Completed Condition: Injury of Radial Artery

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Technologies
FILM, EXTENDED RELEASE;TRANSDERMAL074559-002Aug 30, 1996RXYes<disabled><disabled>
Parke Davis
INJECTABLE;INJECTION070871-001Jan 8, 1987DISCNNo<disabled><disabled>
INJECTABLE;INJECTION018531-001Approved Prior to Jan 1, 1982DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: nitroglycerin

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
FILM, EXTENDED RELEASE;TRANSDERMAL020144-005Feb 27, 19964,954,344<disabled>
Merck Sharp Dohme
FILM, EXTENDED RELEASE;TRANSDERMAL020145-006Apr 4, 19955,186,938<disabled>
Merck Sharp Dohme
FILM, EXTENDED RELEASE;TRANSDERMAL020145-005Apr 4, 19955,186,938<disabled>
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International Patent Family for Ingredient: nitroglycerin

Country Document Number Publication Date
Australia1969397Nov 07, 1997
World Intellectual Property Organization (WIPO)9738687Oct 23, 1997
Germany69721020Dec 04, 2003
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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 information. There is no warranty that the information contained herein is error free. 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.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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