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Last Updated: August 4, 2020

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NITROLINGUAL Drug Profile

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Which patents cover Nitrolingual, and when can generic versions of Nitrolingual launch?

Nitrolingual is a drug marketed by Pohl Boskamp and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

The generic ingredient in NITROLINGUAL 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 Nitrolingual

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

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Drug patent expirations by year for NITROLINGUAL
Drug Prices for NITROLINGUAL

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Drug Sales Revenue Trends for NITROLINGUAL

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Recent Clinical Trials for NITROLINGUAL

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SponsorPhase
United States Naval Medical Center, San DiegoPhase 2
University of ZurichPhase 4

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Pharmacology for NITROLINGUAL
Drug ClassNitrate Vasodilator
Physiological EffectVasodilation
Paragraph IV (Patent) Challenges for NITROLINGUAL
Tradename Dosage Ingredient NDA Submissiondate
NITROLINGUAL AEROSOL;SUBLINGUAL nitroglycerin 018705 2012-04-17
NITROLINGUAL PUMPSPRAY SPRAY, METERED;SUBLINGUAL nitroglycerin 018705 2012-04-17

US Patents and Regulatory Information for NITROLINGUAL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pohl Boskamp NITROLINGUAL nitroglycerin AEROSOL;SUBLINGUAL 018705-001 Oct 31, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Pohl Boskamp NITROLINGUAL PUMPSPRAY nitroglycerin SPRAY, METERED;SUBLINGUAL 018705-002 Jan 10, 1997 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Harvard Business School
McKinsey
Express Scripts
Moodys

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