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 Aase og Ejnar Danielsen Foundation | Phase 4 |
The Novo Nordisk Foundation | Phase 4 |
Danish Heart Foundation | 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
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 |
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