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Last Updated: April 25, 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, Auxilium Pharms Llc, Wyeth Ayerst, Astrazeneca, Impax Labs Inc, Sun Pharm Inds Inc, Bausch, Ani Pharms, Hikma Intl Pharms, Par Pharm, Par Pharm Inc, Rubicon, Sandoz, Sun Pharm Industries, Superpharm, Watson Labs, Zydus, 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.

Summary for isosorbide

US Patents:	0
Tradenames:	9
Applicants:	37
NDAs:	68
Drug Master File Entries:	37
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	74
Patent Applications:	6,726
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for isosorbide
DailyMed Link:	isosorbide at DailyMed

Drug Prices for isosorbide

See drug prices for isosorbide

Recent Clinical Trials for isosorbide

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

Sponsor	Phase
Johannes Grand	Phase 4
Bispebjerg Hospital	Phase 4
Zealand University Hospital	Phase 4

See all isosorbide clinical trials

Medical Subject Heading (MeSH) Categories for isosorbide

Diuretics, Osmotic

US Patents and Regulatory Information for isosorbide

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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
Astrazeneca	SORBITRATE	isosorbide dinitrate	TABLET;ORAL	016192-001	Apr 1, 1996		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Par Pharm	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	087946-001	Jan 12, 1988	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma Intl Pharms	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	040591-001	Jan 10, 2007		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Riconpharma Llc	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	210918-002	Nov 5, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	ISORDIL	isosorbide dinitrate	TABLET;ORAL	012093-001	Jul 29, 1988	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	218255-003	Feb 15, 2024	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Omnivium Pharms	MONOKET	isosorbide mononitrate	TABLET;ORAL	020215-002	Jun 30, 1993	AB	RX	Yes	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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