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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 one branded drug marketed by Arbor Pharms Llc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Hydralazine hydrochloride; isosorbide dinitrate has four patent family members in four countries.
There are twenty-one drug master file entries for hydralazine hydrochloride; isosorbide dinitrate. One supplier is listed for this compound.
Summary for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
International Patents: | 4 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 21 |
Suppliers / Packagers: | 1 |
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 |
---|---|
Danish Heart Foundation | Phase 4 |
The Novo Nordisk Foundation | Phase 4 |
The Aase og Ejnar Danielsen 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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Arbor Pharms Llc | BIDIL | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 020727-001 | Jun 23, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Arbor Pharms Llc | BIDIL | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 020727-001 | Jun 23, 2005 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
>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 |
---|---|---|---|---|---|---|---|
Arbor Pharms Llc | BIDIL | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 020727-001 | Jun 23, 2005 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
Country | Patent Number | Estimated Expiration |
---|---|---|
Australia | 7365900 | Start Trial |
European Patent Office | 1212053 | Start Trial |
World Intellectual Property Organization (WIPO) | 0117528 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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