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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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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 verifification 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.
ISSN: 2162-2639
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