Givinostat hydrochloride - Generic Drug Details
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What are the generic drug sources for givinostat hydrochloride and what is the scope of freedom to operate?
Givinostat hydrochloride
is the generic ingredient in one branded drug marketed by Italfarmaco Spa and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Givinostat hydrochloride has fifty-eight patent family members in twenty-nine countries.
One supplier is listed for this compound.
Summary for givinostat hydrochloride
| International Patents: | 58 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 15 |
| Patent Applications: | 2 |
| DailyMed Link: | givinostat hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for givinostat hydrochloride
Generic Entry Date for givinostat hydrochloride*:
Constraining patent/regulatory exclusivity:
TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 6 YEARS OF AGE AND OLDER Dosage:
SUSPENSION;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 |
Anatomical Therapeutic Chemical (ATC) Classes for givinostat hydrochloride
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Italfarmaco Spa | DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865-001 | Mar 21, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Italfarmaco Spa | DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865-001 | Mar 21, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Italfarmaco Spa | DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865-001 | Mar 21, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Italfarmaco Spa | DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865-001 | Mar 21, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for givinostat hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2012368818 | Diethyl- [6- (4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl) - naphthalen-2-yl-methyl] -ammonium chloride for use in the treatment of muscular dystrophy | ⤷ Sign Up |
| Australia | 2016349169 | Physically and chemically stable oral suspensions of Givinostat | ⤷ Sign Up |
| Peru | 20181369 | SUSPENSIONES ORALES ACUOSAS FISICA Y QUIMICAMENTE ESTABLES DE GIVINOSTAT | ⤷ Sign Up |
| New Zealand | 741467 | Physically and chemically stable oral suspensions of givinostat | ⤷ Sign Up |
| European Patent Office | 2809313 | CHLORURE DE DIÉTHYL-[6-(4-HYDROXYCARBAMOYL-PHÉNYL-CARBAMOYLOXY-MÉTHYL)-NAPHTALÈNE -2-YL-MÉTHYL]AMMONIUM POUR UNE UTILISATION DANS LE TRAITEMENT DE LA DYSTROPHIE MUSCULAIRE (DIETHYL- [6- (4-HYDROXYCARBAMOYL-PHENYL-CARBAMOYLOXY-METHYL) - NAPHTHALEN-2-YL-METHYL]-AMMONIUM CHLORIDE FOR USE IN THE TREATMENT OF MUSCULAR DYSTROPHY) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
