ISOSORBIDE MONONITRATE - Generic Drug Details

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

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, Zydus Pharms, Promius Pharma, Ani Pharms, Hikma Pharms, and Omnivium Pharms, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

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

Sponsor

Phase

Al-Azhar University

Early Phase 1

Cairo University

Phase 1

Suez Canal University

Early Phase 1

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	216557-001	Nov 7, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Promius Pharma	ISMO	isosorbide mononitrate	TABLET;ORAL	019091-001	Dec 30, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	218255-003	Feb 15, 2024		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkermes Gainesville	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	075041-001	Sep 22, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Omnivium Pharms	MONOKET	isosorbide mononitrate	TABLET;ORAL	020215-002	Jun 30, 1993	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Elizabeth	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET;ORAL	075037-002	Oct 30, 1998	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Accord Hlthcare	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	209684-003	Oct 24, 2017		DISCN	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

US Patents:	0
Tradenames:	4
Applicants:	20
NDAs:	23
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	25
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	50
Drug Prices:	Drug price trends for ISOSORBIDE MONONITRATE
What excipients (inactive ingredients) are in ISOSORBIDE MONONITRATE?	ISOSORBIDE MONONITRATE excipients list
DailyMed Link:	ISOSORBIDE MONONITRATE at DailyMed

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation