You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 24, 2024

Hydralazine hydrochloride; isosorbide dinitrate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
Recent Clinical Trials for hydralazine hydrochloride; isosorbide dinitrate

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

SponsorPhase
The Aase og Ejnar Danielsen FoundationPhase 4
The Novo Nordisk FoundationPhase 4
Danish Heart FoundationPhase 4

See all hydralazine hydrochloride; isosorbide dinitrate clinical trials

Pharmacology for hydralazine hydrochloride; isosorbide dinitrate

US Patents and Regulatory Information for hydralazine hydrochloride; isosorbide dinitrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Azurity BIDIL hydralazine hydrochloride; isosorbide dinitrate TABLET;ORAL 020727-001 Jun 23, 2005 AB RX Yes Yes ⤷  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
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
>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

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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.