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Last Updated: February 4, 2023

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, 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

Johannes GrandPhase 4
Bispebjerg HospitalPhase 4
Zealand University HospitalPhase 4

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Pharmacology for isosorbide dinitrate
Drug ClassNitrate Vasodilator
Physiological Effect Vasodilation
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
Bausch ISORDIL isosorbide dinitrate TABLET;ORAL 012093-005 Jul 29, 1988 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm Industries ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;SUBLINGUAL 087545-001 Sep 18, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Par Pharm ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;ORAL 087537-001 Oct 2, 1987 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.