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Nitroglycerin - Generic Drug Details

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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, Valeant Pharms North, 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. Thirty-two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for Generic Name: nitroglycerin

Tradenames:15
Patents:3
Applicants:23
NDAs:40
Drug Master File Entries: see list36
Suppliers / Packaging: see list32
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: nitroglycerin

Ingredient-typeNitrates
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

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer Pharms
NITROSTAT
nitroglycerin
TABLET;SUBLINGUAL021134-003May 1, 2000RXYes6,500,456<disabled> <disabled>
Mylan Technologies
NITROGLYCERIN
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL074992-002Nov 12, 1999DISCNNo<disabled><disabled>
Hospira
TRIDIL
nitroglycerin
INJECTABLE;INJECTION018537-002Jun 16, 1983DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: nitroglycerin

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
TRANSDERM-NITRO
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020144-002Feb 27, 19964,849,226<disabled>
Novartis
TRANSDERM-NITRO
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020144-004Feb 27, 19964,954,344<disabled>
Merck Sharp Dohme
NITRO-DUR
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020145-004Apr 4, 19955,186,938<disabled>
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International Patent Family for Ingredient: nitroglycerin

Country Document Number Estimated Expiration
Australia759018<disabled in preview>
Australia9489398<disabled in preview>
Portugal927032<disabled in preview>
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