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Last Updated: September 25, 2022

NITROSTAT Drug Patent Profile


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Which patents cover Nitrostat, and what generic alternatives are available?

Nitrostat is a drug marketed by Parke Davis and Viatris and is included in five NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Nitrostat

A generic version of NITROSTAT was approved as nitroglycerin by AM REGENT on May 24th, 1988.

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Drug patent expirations by year for NITROSTAT
Drug Prices for NITROSTAT

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Drug Sales Revenue Trends for NITROSTAT

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Recent Clinical Trials for NITROSTAT

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SponsorPhase
Futura Medical Developments Ltd.Phase 1
Montefiore Medical CenterN/A
Mayo ClinicN/A

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Pharmacology for NITROSTAT
Drug ClassNitrate Vasodilator
Physiological Effect Vasodilation
Paragraph IV (Patent) Challenges for NITROSTAT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
NITROSTAT Sublingual Tablets nitroglycerin 0.3 mg, 0.4 mg, and 0.6 mg 021134 1 2005-10-19

US Patents and Regulatory Information for NITROSTAT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Parke Davis NITROSTAT nitroglycerin INJECTABLE;INJECTION 018588-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-002 May 1, 2000 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Parke Davis NITROSTAT nitroglycerin INJECTABLE;INJECTION 070871-001 Jan 8, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NITROSTAT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-001 May 1, 2000 See Plans and Pricing See Plans and Pricing
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-003 May 1, 2000 See Plans and Pricing See Plans and Pricing
Viatris NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-002 May 1, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for NITROSTAT

See the table below for patents covering NITROSTAT around the world.

Country Patent Number Title Estimated Expiration
Brazil 9812605 composiÇço estÁvel, tablete comprimido estÁvel e processo para preparaÇço. See Plans and Pricing
Israel 134395 COMPRESSED NITROGYLYCERIN TABLET AND ITS METHOD OF MANUFACTURE See Plans and Pricing
World Intellectual Property Organization (WIPO) 9917766 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Baxter
McKinsey
Medtronic
Colorcon
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 verification 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.