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, 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
Strides Pharma	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	090598-003	Aug 11, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Molecular	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	075155-002	Jan 13, 2000	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ivax Sub Teva Pharms	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	075448-003	Aug 7, 2001		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	218255-001	Feb 15, 2024		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	216557-003	Nov 7, 2022	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

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