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Serving leading biopharmaceutical companies globally:

Fuji
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Generated: December 13, 2017

DrugPatentWatch Database Preview

NITROSTAT Drug Profile

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When do Nitrostat patents expire, and when can generic versions of Nitrostat launch?

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

This drug has eighteen patent family members in sixteen countries.

The generic ingredient in NITROSTAT is nitroglycerin. There are thirty-six drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Drug patent expirations by year for NITROSTAT

Pharmacology for NITROSTAT

Ingredient-typeNitrates
Drug ClassNitrate Vasodilator
Physiological EffectVasodilation

Medical Subject Heading (MeSH) Categories for NITROSTAT

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Parke DavisNITROSTATnitroglycerinINJECTABLE;INJECTION018588-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Pfizer PharmsNITROSTATnitroglycerinTABLET;SUBLINGUAL021134-002May 1, 2000ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Parke DavisNITROSTATnitroglycerinINJECTABLE;INJECTION070871-001Jan 8, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Pfizer PharmsNITROSTATnitroglycerinTABLET;SUBLINGUAL021134-003May 1, 2000ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Parke DavisNITROSTATnitroglycerinINJECTABLE;INJECTION070863-001Jan 8, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Parke DavisNITROSTATnitroglycerinINJECTABLE;INJECTION018588-002Dec 23, 1983DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Pfizer PharmsNITROSTATnitroglycerinTABLET;SUBLINGUAL021134-001May 1, 2000ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Parke DavisNITROSTATnitroglycerinINJECTABLE;INJECTION070872-001Jan 8, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
New Zealand502878► Subscribe
Canada2299231► Subscribe
Israel134395► Subscribe
Japan2001518500► Subscribe
Australia759018► Subscribe
Slovenia1019039► Subscribe
Germany69802832► Subscribe
European Patent Office1019039► Subscribe
Australia9489398► Subscribe
Austria209911► 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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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
Express Scripts
Julphar
McKinsey
Harvard Business School
Covington
Chubb
Healthtrust
AstraZeneca

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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