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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 freedom to operate?

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.

Summary for ISOSORBIDE

US Patents:	0
Tradenames:	9
Applicants:	35
NDAs:	68
Drug Master File Entries:	37
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	74
Patent Applications:	6,726
Drug Prices:	Drug price trends for ISOSORBIDE
DailyMed Link:	ISOSORBIDE at DailyMed

Drug Prices for ISOSORBIDE

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Recent Clinical Trials for ISOSORBIDE

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

Sponsor	Phase
Zealand University Hospital	Phase 4
Copenhagen University Hospital, Hvidovre	Phase 4
Johannes Grand	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
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
Zydus Pharms	ISOSORBIDE MONONITRATE	isosorbide mononitrate	TABLET, EXTENDED RELEASE;ORAL	218255-003	Feb 15, 2024		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	ISORDIL	isosorbide dinitrate	TABLET;ORAL	012093-006	Jul 29, 1988		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	SORBITRATE	isosorbide dinitrate	TABLET;ORAL	016192-002	Apr 1, 1996		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

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