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Last Updated: September 22, 2020

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TRANSDERM-NITRO Drug Profile

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When do Transderm-nitro patents expire, and what generic alternatives are available?

Transderm-nitro is a drug marketed by Novartis and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Transderm-nitro

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

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Summary for TRANSDERM-NITRO
Drug patent expirations by year for TRANSDERM-NITRO
Recent Clinical Trials for TRANSDERM-NITRO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Repurposed Therapeutics, Inc.Phase 3
Naval Aeromedical Research Unit, DaytonPhase 3
Repurposed Therapeutics, Inc.Phase 2/Phase 3

See all TRANSDERM-NITRO clinical trials

Paragraph IV (Patent) Challenges for TRANSDERM-NITRO
Tradename Dosage Ingredient NDA Submissiondate
TRANSDERM-NITRO FILM, EXTENDED RELEASE;TRANSDERMAL nitroglycerin 020144

US Patents and Regulatory Information for TRANSDERM-NITRO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-001 Feb 27, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-004 Feb 27, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-002 Feb 27, 1996 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-003 Feb 27, 1996 DISCN Yes 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 TRANSDERM-NITRO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-005 Feb 27, 1996   Start Trial   Start Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-001 Feb 27, 1996   Start Trial   Start Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-003 Feb 27, 1996   Start Trial   Start Trial
Novartis TRANSDERM-NITRO nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020144-003 Feb 27, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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