ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE Drug Patent Profile
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When do Isosorbide Dinitrate And Hydralazine Hydrochloride patents expire, and what generic alternatives are available?
Isosorbide Dinitrate And Hydralazine Hydrochloride is a drug marketed by I3 Pharms and Riconpharma Llc and is included in two NDAs.
The generic ingredient in ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE is hydralazine hydrochloride; isosorbide dinitrate. There are twenty-one drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the hydralazine hydrochloride; isosorbide dinitrate profile page.
Summary for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 3 |
| Clinical Trials: | 7 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE? | ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE excipients list |
| DailyMed Link: | ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The Danish Regions: Foundation for Medical Research | Phase 4 |
| Danish Council for Independent Research | Phase 4 |
| Henrik Wiggers | Phase 4 |
See all ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE clinical trials
Pharmacology for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
| Drug Class | Arteriolar Vasodilator Nitrate Vasodilator |
| Physiological Effect | Arteriolar Vasodilation Vasodilation |
Anatomical Therapeutic Chemical (ATC) Classes for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
US Patents and Regulatory Information for ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Riconpharma Llc | ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE | hydralazine hydrochloride; isosorbide dinitrate | TABLET;ORAL | 215586-001 | Apr 6, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
