ISOSORBIDE DINITRATE - Generic Drug Details

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What are the generic sources for isosorbide dinitrate and what is the scope of freedom to operate?

Isosorbide dinitrate is the generic ingredient in four branded drugs marketed by 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, and Watson Labs Teva, and is included in forty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for isosorbide dinitrate. Twenty-one suppliers are listed for this compound.

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

Sponsor

Phase

Johannes Grand

Phase 4

Bispebjerg Hospital

Phase 4

Zealand University Hospital

Phase 4

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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
Biovail	ISORDIL	isosorbide dinitrate	TABLET;SUBLINGUAL	012940-005	Jul 29, 1988		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Industries	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;SUBLINGUAL	086168-001	Sep 18, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rubicon	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	215723-001	Jul 8, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Par Pharm Inc	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	211290-001	Nov 23, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	ISORDIL	isosorbide dinitrate	TABLET;ORAL	012093-007	Jul 29, 1988	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Impax Labs Inc	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET, EXTENDED RELEASE;ORAL	040723-001	Mar 17, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Biovail	ISORDIL	isosorbide dinitrate	TABLET;SUBLINGUAL	012940-004	Jul 29, 1988		DISCN	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

US Patents:	0
Tradenames:	4
Applicants:	18
NDAs:	44
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	29
Patent Applications:	6,397
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ISOSORBIDE DINITRATE
What excipients (inactive ingredients) are in ISOSORBIDE DINITRATE?	ISOSORBIDE DINITRATE excipients list
DailyMed Link:	ISOSORBIDE DINITRATE at DailyMed

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation