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Last Updated: May 10, 2021

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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-two 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

SponsorPhase
Pr. Semir NouiraPhase 3
Children's Hospital Medical Center, CincinnatiPhase 2
The Danish Regions: Foundation for Medical ResearchPhase 4

See all isosorbide dinitrate clinical trials

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
Biovail ISORDIL isosorbide dinitrate TABLET;SUBLINGUAL 012940-003 Jul 29, 1988 DISCN Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Bausch ISORDIL isosorbide dinitrate TABLET;ORAL 012093-001 Jul 29, 1988 AB RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Sandoz ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086221-001 Jan 7, 1988 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
>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:

Medtronic
Colorcon
Boehringer Ingelheim
Express Scripts
Mallinckrodt
AstraZeneca

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