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Nitroglycerin - Generic Drug Details

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Nitroglycerin is the generic ingredient in sixteen 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-one NDAs. There are four patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-seven 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:16
Patents:4
Applicants:23
NDAs:41
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
Hospira
NITROGLYCERIN IN DEXTROSE 5%
nitroglycerin
INJECTABLE;INJECTION071846-001Aug 31, 1990RXNo<disabled><disabled>
Merck Sharp Dohme
NITRO-DUR
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020145-002Apr 4, 1995RXYes<disabled><disabled>
Pfizer Pharms
NITROSTAT
nitroglycerin
TABLET;SUBLINGUAL021134-002May 1, 2000RXNo6,500,456<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;TRANSDERMAL020144-004Feb 27, 19964,812,313<disabled>
Novartis
TRANSDERM-NITRO
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020144-005Feb 27, 19964,812,313<disabled>
Novartis
TRANSDERM-NITRO
nitroglycerin
FILM, EXTENDED RELEASE;TRANSDERMAL020144-003Feb 27, 19964,812,313<disabled>
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International Patent Family for Ingredient: nitroglycerin

Country Document Number Estimated Expiration
New Zealand502878<disabled in preview>
Australia759018<disabled in preview>
Russian Federation2010142023<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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