GIVINOSTAT HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for givinostat hydrochloride and what is the scope of patent protection?
Givinostat hydrochloride
is the generic ingredient in one branded drug marketed by Italfarmaco Spa and is included in one NDA. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for GIVINOSTAT HYDROCHLORIDE
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 14 |
DailyMed Link: | GIVINOSTAT HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for GIVINOSTAT HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Italfarmaco | Phase 1 |
Cromsource | Phase 2/Phase 3 |
Italfarmaco | Phase 2/Phase 3 |
US Patents and Regulatory Information for GIVINOSTAT HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Italfarmaco Spa | DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865-001 | Mar 21, 2024 | RX | Yes | Yes | ⤷ 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 |