DUVYZAT Drug Patent Profile

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Which patents cover Duvyzat, and when can generic versions of Duvyzat launch?

Duvyzat is a drug marketed by Italfarmaco Spa and is included in one NDA. There are five patents protecting this drug.

The generic ingredient in DUVYZAT is givinostat hydrochloride. One supplier is listed for this compound. Additional details are available on the givinostat hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Duvyzat

Duvyzat will be eligible for patent challenges on March 21, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 21, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for DUVYZAT

US Patents:	5
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for DUVYZAT

DUVYZAT is protected by five US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DUVYZAT is ⤷ Start Trial.

This potential generic entry date is based on TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 6 YEARS OF AGE AND OLDER.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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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	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y	Y		⤷ Start Trial
>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 DUVYZAT

See the table below for patents covering DUVYZAT around the world.

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Country	Patent Number	Title	Estimated Expiration
Argentina	106559		⤷ Start Trial
Australia	2016349169		⤷ Start Trial
Brazil	112018008870		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DUVYZAT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3370697	2025C/548	Belgium	⤷ Start Trial	PRODUCT NAME: GIVINOSTAT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, INCLUSIEF HYDROCHLORIDEMONOHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/25/1930 20250606
3370697	PA2025540	Lithuania	⤷ Start Trial	PRODUCT NAME: DUVIZAT (GIVINOSTAT); REGISTRATION NO/DATE: EU/1/25/1930 20250606
3370697	CA 2025 00043	Denmark	⤷ Start Trial	PRODUCT NAME: GIVINOSTAT I EN HVILKEN SOM HELST FORM BESKYTTET AF BASISPATENTET; REG. NO/DATE: EU/1/25/1930 20250606
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Indicators of Generic Entry

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Summary for DUVYZAT

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