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Last Updated: March 19, 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
Suez Canal UniversityEarly Phase 1

See all isosorbide mononitrate clinical trials

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
Actavis Elizabeth ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET;ORAL 075037-001 Oct 30, 1998 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
Aurobindo Pharma ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 216557-001 Nov 7, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkermes Gainesville ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 075041-001 Sep 22, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ivax Sub Teva Pharms ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 075448-002 Aug 7, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Actavis Elizabeth ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 075306-002 Dec 31, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 216557-002 Nov 7, 2022 AB RX 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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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.