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 four patents protecting this drug.

This drug has fifty-eight patent family members in twenty-nine countries.

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

International Patents:	58
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in DUVYZAT?	DUVYZAT excipients list
DailyMed Link:	DUVYZAT at DailyMed

Drug patent expirations by year for DUVYZAT

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DUVYZAT

Generic Entry Date for DUVYZAT^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 6 YEARS OF AGE AND OLDER NDA: 217865 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.

US Patents and Regulatory Information for DUVYZAT

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

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

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.

Patents protecting DUVYZAT

Physically and chemically stable oral suspensions of givinostat
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) USING GIVINOSTAT

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride for use in the treatment of muscular dystrophy
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) USING GIVINOSTAT

FDA Regulatory Exclusivity protecting DUVYZAT

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 6 YEARS OF AGE AND OLDER
Exclusivity Expiration: ⤷ Sign Up

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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	⤷ 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
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			⤷ 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 DUVYZAT

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

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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
>Country	>Patent Number	>Title	>Estimated Expiration