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NITROSTAT Drug Profile

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Nitrostat is a drug marketed by Pfizer Pharms and Parke Davis and is included in five NDAs. It is available from eleven suppliers. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has thirteen patent family members in fifteen countries.

The generic ingredient in NITROSTAT is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-six suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the nitroglycerin profile page.

Summary for Tradename: NITROSTAT

Patents:1
Applicants:2
NDAs:5
Suppliers / Packagers: see list11
Drug Prices: :see details

Pharmacology for Tradename: NITROSTAT

Ingredient-typeNitrates
Drug ClassNitrate Vasodilator
Physiological EffectVasodilation
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;SUBLINGUAL021134-001May 1, 2000RXNo6,500,456► subscribe ► subscribe
Parke Davis
NITROSTAT
nitroglycerin
INJECTABLE;INJECTION018588-001Approved Prior to Jan 1, 1982DISCNNo► subscribe► subscribe
Parke Davis
NITROSTAT
nitroglycerin
INJECTABLE;INJECTION070863-001Jan 8, 1987DISCNNo► subscribe► subscribe
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Paragraph IV activity for: NITROSTAT

Drugname Dosage Strength RLD Submissiondate
nitroglycerinSublingual Tablets0.6 mgNitrostat12/29/2011
nitroglycerinSublingual Tablets0.3 mg, 0.4 mg and 0.6 mgNitrostat10/19/2005

International Patent Family for Tradename: NITROSTAT

Country Document Number Estimated Expiration
Slovenia1019039► subscribe
Germany69802832► subscribe
European Patent Office1019039► subscribe
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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.

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