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Last Updated: September 22, 2020

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NITRO-DUR Drug Profile

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When do Nitro-dur patents expire, and when can generic versions of Nitro-dur launch?

Nitro-dur is a drug marketed by Uspharma and is included in one NDA.

The generic ingredient in NITRO-DUR 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 Nitro-dur

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

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Paragraph IV (Patent) Challenges for NITRO-DUR
Tradename Dosage Ingredient NDA Submissiondate
NITRO-DUR FILM, EXTENDED RELEASE;TRANSDERMAL nitroglycerin 020145

US Patents and Regulatory Information for NITRO-DUR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-001 Apr 4, 1995 BX RX Yes Yes   Start Trial   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-004 Apr 4, 1995 BX RX Yes Yes   Start Trial   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-002 Apr 4, 1995 BX RX Yes Yes   Start Trial   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-003 Apr 4, 1995 RX Yes Yes   Start Trial   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-006 Apr 4, 1995 RX Yes Yes   Start Trial   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-005 Apr 4, 1995 BX RX Yes Yes   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 NITRO-DUR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-001 Apr 4, 1995   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-004 Apr 4, 1995   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-003 Apr 4, 1995   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-005 Apr 4, 1995   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-002 Apr 4, 1995   Start Trial   Start Trial
Uspharma NITRO-DUR nitroglycerin FILM, EXTENDED RELEASE;TRANSDERMAL 020145-006 Apr 4, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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