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Boehringer Ingelheim
Express Scripts

Last Updated: August 4, 2020

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Isosorbide dinitrate - Generic Drug Details

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What are the generic sources for isosorbide dinitrate and what is the scope of patent protection?

Isosorbide dinitrate is the generic ingredient in four branded drugs marketed by Auxilium Pharms Llc, Wyeth Ayerst, Astrazeneca, Impax Labs Inc, Sun Pharm Inds Inc, Bausch, Ani Pharms Inc, Hikma Intl Pharms, Par Pharm, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus, Biovail, and Watson Labs Teva, and is included in forty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-seven drug master file entries for isosorbide dinitrate. Twenty suppliers are listed for this compound.

Drug Prices for isosorbide dinitrate

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Recent Clinical Trials for isosorbide dinitrate

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

Children's Hospital Medical Center, CincinnatiPhase 2
Danish Council for Independent ResearchPhase 4
The Danish Regions: Foundation for Medical ResearchPhase 4

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Pharmacology for isosorbide dinitrate
Drug ClassNitrate Vasodilator
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for isosorbide dinitrate

US Patents and Regulatory Information for isosorbide dinitrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca SORBITRATE isosorbide dinitrate TABLET;ORAL 088125-001 Aug 21, 1990 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086167-001 Sep 19, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Superpharm ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 089190-001 Feb 17, 1987 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

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts

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