Isosorbide dinitrate - Generic Drug Details

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

Isosorbide dinitrate is the generic ingredient in four branded drugs marketed by 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, 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-two suppliers are listed for this compound.

Sponsor	Phase
Copenhagen University Hospital, Hvidovre	Phase 4
Johannes Grand	Phase 4
Bispebjerg Hospital	Phase 4

Sponsor

Phase

Copenhagen University Hospital, Hvidovre

Phase 4

Johannes Grand

Phase 4

Bispebjerg 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
Bausch	ISORDIL	isosorbide dinitrate	TABLET;ORAL	012093-006	Jul 29, 1988		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Lifesciences	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	213057-005	Nov 20, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Lifesciences	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	213057-004	Nov 20, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;SUBLINGUAL	086225-001	Feb 19, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	ISORDIL	isosorbide dinitrate	TABLET;ORAL	012093-002	Jul 29, 1988		DISCN	Yes	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:	16
NDAs:	44
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	29
Patent Applications:	6,245
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