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Last Updated: April 23, 2024

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, Hikma Intl Pharms, Par Pharm, Par Pharm Inc, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus, Biovail, and Watson Labs Teva, and is included in forty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen 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
Zealand University HospitalPhase 4
Copenhagen University Hospital, HvidovrePhase 4
Johannes GrandPhase 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
Sandoz ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 089367-001 Apr 7, 1988 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Par Pharm ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 087537-001 Oct 2, 1987 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch ISORDIL isosorbide dinitrate TABLET;ORAL 012093-006 Jul 29, 1988 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Superpharm ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 089191-001 Feb 17, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Industries ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086167-001 Sep 19, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma Intl Pharms ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 086067-001 Oct 29, 1987 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch ISORDIL isosorbide dinitrate TABLET;ORAL 012093-007 Jul 29, 1988 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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