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Last Updated: March 28, 2024

Isosorbide mononitrate - Generic Drug Details


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What are the generic sources for isosorbide mononitrate and what is the scope of freedom to operate?

Isosorbide mononitrate is the generic ingredient in four branded drugs marketed by Schering Plough, Accord Hlthcare, Actavis Elizabeth, Alkermes Gainesville, Aurobindo Pharma, Chartwell Molecular, Dexcel Ltd, Hikma Intl Pharms, Ivax Sub Teva Pharms, Riconpharma Llc, Shandong, Skyepharma Ag, Strides Pharma, Torrent Pharms, Zydus Hlthcare, Promius Pharma, Ani Pharms, Hikma Pharms, and Omnivium Pharms, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for isosorbide mononitrate. Twenty-three suppliers are listed for this compound.

Drug Prices for isosorbide mononitrate

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Drug Sales Revenue Trends for isosorbide mononitrate

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Recent Clinical Trials for isosorbide mononitrate

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SponsorPhase
Al-Azhar UniversityEarly Phase 1
Cairo UniversityPhase 1
Aljazeera HospitalEarly Phase 1

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Pharmacology for isosorbide mononitrate
Drug ClassNitrate Vasodilator
Physiological EffectVasodilation

US Patents and Regulatory Information for isosorbide mononitrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 090598-002 Aug 11, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Riconpharma Llc ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 210918-003 Nov 5, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Skyepharma Ag ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 075166-001 Oct 7, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma Intl Pharms ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 076813-001 Jan 7, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ivax Sub Teva Pharms ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 075448-003 Aug 7, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Accord Hlthcare ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 209684-003 Oct 24, 2017 DISCN No 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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