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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, Dr Reddys Labs Inc, and Perrigo Israel, and is included in forty-two 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-six 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 list36
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

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

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare
INJECTABLE;INJECTION019970-001Dec 29, 1989RXYes
Parke Davis
Smith And Nephew
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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
Merck Sharp Dohme
FILM, EXTENDED RELEASE;TRANSDERMAL020145-004Apr 4, 19955,186,938<disabled>
FILM, EXTENDED RELEASE;TRANSDERMAL020144-004Feb 27, 19964,955,344<disabled>
Mist Pharms Llc
AEROSOL, METERED;SUBLINGUAL021780-001Nov 2, 20065,869,082<disabled>
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International Patent Family for Ingredient: nitroglycerin

Country Document Number Estimated Expiration
European Patent Office2678006<disabled in preview>
World Intellectual Property Organization (WIPO)9738687<disabled in preview>
Germany69802832<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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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 verifification 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.