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Last Updated: August 12, 2020

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ISOSORBIDE DINITRATE Drug Profile

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Which patents cover Isosorbide Dinitrate, and what generic alternatives are available?

Isosorbide Dinitrate is a drug marketed by Impax Labs Inc, Sun Pharm Inds Inc, Ani Pharms Inc, Hikma Intl Pharms, Par Pharm, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus, and Watson Labs Teva. and is included in thirty-two NDAs.

The generic ingredient in ISOSORBIDE DINITRATE is isosorbide dinitrate. There are thirty-seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.

US ANDA Litigation and Generic Entry Outlook for Isosorbide Dinitrate

A generic version of ISOSORBIDE DINITRATE was approved as isosorbide dinitrate by PAR PHARM on March 12th, 1987.

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Drug patent expirations by year for ISOSORBIDE DINITRATE
Drug Prices for ISOSORBIDE DINITRATE

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Recent Clinical Trials for ISOSORBIDE DINITRATE

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SponsorPhase
Children's Hospital Medical Center, CincinnatiPhase 2
Danish Heart FoundationPhase 4
The Novo Nordisk FoundationPhase 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
Sun Pharm Industries ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;SUBLINGUAL 084204-001 Sep 18, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma Intl Pharms ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;SUBLINGUAL 086054-001 Oct 29, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries ISOSORBIDE DINITRATE isosorbide dinitrate TABLET;SUBLINGUAL 086168-001 Sep 18, 1986 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
>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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