HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE - Generic Drug Details

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

Hydralazine hydrochloride; isosorbide dinitrate is the generic ingredient in two branded drugs marketed by Azurity, I3 Pharms, and Riconpharma Llc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	6
Clinical Trials:	7
DailyMed Link:	HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE at DailyMed

Recent Clinical Trials for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

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

Sponsor	Phase
The Novo Nordisk Foundation	Phase 4
Danish Heart Foundation	Phase 4
The Danish Regions: Foundation for Medical Research	Phase 4

See all HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE clinical trials

Pharmacology for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

Drug Class	Arteriolar Vasodilator Nitrate Vasodilator
Physiological Effect	Arteriolar Vasodilation Vasodilation

Anatomical Therapeutic Chemical (ATC) Classes for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

US Patents and Regulatory Information for HYDRALAZINE HYDROCHLORIDE; 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
I3 Pharms	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215988-001	Jan 17, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Riconpharma Llc	ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	215586-001	Apr 6, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005	AB	RX	Yes	Yes	⤷ 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

Expired US Patents for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005	⤷ Sign Up	⤷ Sign Up
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005	⤷ Sign Up	⤷ Sign Up
Azurity	BIDIL	hydralazine hydrochloride; isosorbide dinitrate	TABLET;ORAL	020727-001	Jun 23, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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