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Last Updated: November 22, 2024

Isosorbide - Generic Drug Details


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What are the generic sources for isosorbide and what is the scope of patent protection?

Isosorbide is the generic ingredient in nine branded drugs marketed by Alcon, Endo Operations, Wyeth Ayerst, Astrazeneca, Impax Labs Inc, Sun Pharm Inds Inc, Bausch, Ani Pharms, Hikma Intl Pharms, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus Lifesciences, Biovail, Watson Labs Teva, Schering Plough, Accord Hlthcare, Actavis Elizabeth, Alkermes Gainesville, Aurobindo Pharma, Chartwell Molecular, Dexcel Ltd, Ivax Sub Teva Pharms, Riconpharma Llc, Shandong, Skyepharma Ag, Strides Pharma, Torrent Pharms, Zydus Hlthcare, Zydus Pharms, Promius Pharma, Hikma Pharms, and Omnivium Pharms, and is included in sixty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-seven drug master file entries for isosorbide.

Drug Prices for isosorbide

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Recent Clinical Trials for isosorbide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Johannes GrandPhase 4
Bispebjerg HospitalPhase 4
Zealand University HospitalPhase 4

See all isosorbide clinical trials

Medical Subject Heading (MeSH) Categories for isosorbide

US Patents and Regulatory Information for isosorbide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Sub Teva Pharms ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 075448-002 Aug 7, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Riconpharma Llc ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 210918-002 Nov 5, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Molecular ISOSORBIDE MONONITRATE isosorbide mononitrate TABLET, EXTENDED RELEASE;ORAL 075155-001 Oct 30, 1998 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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