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 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.

Summary for ISOSORBIDE DINITRATE

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

See drug prices for ISOSORBIDE DINITRATE

Recent Clinical Trials for ISOSORBIDE DINITRATE

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

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

See all ISOSORBIDE DINITRATE clinical trials

Pharmacology for ISOSORBIDE DINITRATE

Drug Class	Nitrate Vasodilator
Physiological Effect	Vasodilation

Medical Subject Heading (MeSH) Categories for ISOSORBIDE DINITRATE

Nitric Oxide Donors
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for ISOSORBIDE DINITRATE

C01DA	Organic nitrates
C01D	VASODILATORS USED IN CARDIAC DISEASES
C01	CARDIAC THERAPY
C	Cardiovascular system

C05AE	Muscle relaxants
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

US Patents and Regulatory Information for ISOSORBIDE DINITRATE

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Glossary

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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
Endo Operations	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	086923-001	Mar 12, 1987	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	087537-001	Oct 2, 1987	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	086167-001	Sep 19, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Superpharm	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	089192-001	Feb 17, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	ISOSORBIDE DINITRATE	isosorbide dinitrate	TABLET;ORAL	215723-001	Jul 8, 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

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