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Last Updated: September 21, 2020

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Isosorbide dinitrate - Generic Drug Details

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What are the generic drug 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-one 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
Children's Hospital Medical Center, CincinnatiPhase 2
Danish Heart FoundationPhase 4
The Novo Nordisk FoundationPhase 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
Sun Pharm Industries ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;SUBLINGUAL 084204-001 Sep 18, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086169-001 Sep 19, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Impax Labs Inc ISOSORBIDE DINITRATE isosorbide dinitrate TABLET, EXTENDED RELEASE;ORAL 040723-001 Mar 17, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086034-001 Jan 6, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma Intl Pharms ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;SUBLINGUAL 086055-001 Nov 2, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Zydus ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 213057-002 Nov 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086223-001 Jan 7, 1988 AB RX 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:

McKinsey
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Baxter

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