Details for New Drug Application (NDA): 217865
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NDA 217865 describes DUVYZAT, which is a drug marketed by Italfarmaco Spa and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the DUVYZAT profile page.
The generic ingredient in DUVYZAT is givinostat hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the givinostat hydrochloride profile page.
The generic ingredient in DUVYZAT is givinostat hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the givinostat hydrochloride profile page.
Summary for 217865
| Tradename: | DUVYZAT |
| Applicant: | Italfarmaco Spa |
| Ingredient: | givinostat hydrochloride |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217865
Generic Entry Date for 217865*:
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.
Pharmacology for NDA: 217865
Suppliers and Packaging for NDA: 217865
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865 | NDA | Italfarmaco SPA | 11797-110 | 11797-110-02 | 1 BOTTLE in 1 CARTON (11797-110-02) / 140 mL in 1 BOTTLE (11797-110-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;ORAL | Strength | EQ 8.86MG BASE/ML | ||||
| Approval Date: | Mar 21, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 21, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 21, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 6 YEARS OF AGE AND OLDER | ||||||||
| Patent: | 10,688,047 | Patent Expiration: | Oct 28, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) USING GIVINOSTAT | ||||||||
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