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Last Updated: July 12, 2020

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NITROSTAT Drug Profile


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

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

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

US ANDA 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

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Pharmacology for NITROSTAT
Drug ClassNitrate Vasodilator
Physiological EffectVasodilation
Paragraph IV (Patent) Challenges for NITROSTAT
Tradename Dosage Ingredient NDA Submissiondate
NITROSTAT TABLET;SUBLINGUAL nitroglycerin 021134 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   Start Trial   Start Trial   Start Trial
Pfizer Pharms NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-002 May 1, 2000 AB RX Yes No   Start Trial   Start Trial   Start Trial
Parke Davis NITROSTAT nitroglycerin INJECTABLE;INJECTION 070871-001 Jan 8, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Pfizer Pharms NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-003 May 1, 2000 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Parke Davis NITROSTAT nitroglycerin INJECTABLE;INJECTION 070863-001 Jan 8, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Parke Davis NITROSTAT nitroglycerin INJECTABLE;INJECTION 018588-002 Dec 23, 1983 DISCN No No   Start Trial   Start Trial   Start Trial
>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
Pfizer Pharms NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-001 May 1, 2000   Start Trial   Start Trial
Pfizer Pharms NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-003 May 1, 2000   Start Trial   Start Trial
Pfizer Pharms NITROSTAT nitroglycerin TABLET;SUBLINGUAL 021134-002 May 1, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Baxter
McKinsey
Medtronic
Colorcon
AstraZeneca

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