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Last Updated: August 12, 2020

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ISORDIL Drug Profile

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When do Isordil patents expire, and when can generic versions of Isordil launch?

Isordil is a drug marketed by Wyeth Ayerst, Bausch, and Biovail. and is included in three NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Isordil

A generic version of ISORDIL was approved as isosorbide dinitrate by PAR PHARM on March 12th, 1987.

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Drug patent expirations by year for ISORDIL
Drug Prices for ISORDIL

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Recent Clinical Trials for ISORDIL

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SponsorPhase
Children's Hospital Medical Center, CincinnatiPhase 2
Brigham and Women's HospitalPhase 4
Mayo ClinicPhase 3

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Pharmacology for ISORDIL
Drug ClassNitrate Vasodilator
Physiological EffectVasodilation

US Patents and Regulatory Information for ISORDIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Ayerst ISORDIL isosorbide dinitrate CAPSULE, EXTENDED RELEASE;ORAL 012882-002 Jul 29, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Bausch ISORDIL isosorbide dinitrate TABLET;ORAL 012093-001 Jul 29, 1988 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Bausch ISORDIL isosorbide dinitrate TABLET;ORAL 012093-002 Jul 29, 1988 DISCN Yes No   Start Trial   Start Trial   Start Trial
Biovail ISORDIL isosorbide dinitrate TABLET;SUBLINGUAL 012940-004 Jul 29, 1988 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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Boehringer Ingelheim
McKinsey
Colorcon
Express Scripts

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