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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DUVYZAT
Generic Entry Date for DUVYZAT*:
Constraining patent/regulatory exclusivity:
TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 6 YEARS OF AGE AND OLDER NDA:
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 ⤷ Subscribe.
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.
| 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 | 9,421,184 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Italfarmaco Spa | DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865-001 | Mar 21, 2024 | RX | Yes | Yes | 7,329,689 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Italfarmaco Spa | DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865-001 | Mar 21, 2024 | RX | Yes | Yes | 9,867,799 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Italfarmaco Spa | DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865-001 | Mar 21, 2024 | RX | Yes | Yes | 10,688,047 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Italfarmaco Spa | DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865-001 | Mar 21, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Italfarmaco Spa | DUVYZAT | givinostat hydrochloride | SUSPENSION;ORAL | 217865-001 | Mar 21, 2024 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| >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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Cyprus | 1124092 | ⤷ Subscribe | |
| Japan | 2016128504 | 筋ジストロフィーの治療に用いられるジエチル−［６−（４−ヒドロキシカルバモイル−フェニル−カルバモイルオキシ−メチル）−ナフタレン−２−イル−メチル］−アンモニウムクロリド (DIETHYL-[6-(4-HYDROXYCARBAMOYL-PHENYL-CARBAMOYLOXY-METHYL)-NAPHTHALEN-2-YL-METHYL]-AMMONIUM CHLORIDE FOR TREATING MUSCULAR DYSTROPHY) | ⤷ Subscribe |
| Mexico | 370451 | CLORURO DE DIETIL-[6-(4-HIDROXICARBAMOIL-FENIL-CARBAMOILOXI METIL)-NAFTALEN-2-IL-METIL]-AMONIO PARA SU USO EN EL TRATAMIENTO DE DISTROFIA MUSCULAR. (DIETHYL- [6- (4-HYDROXYCARBAMOYL-PHENYL-CARBAMOYLOXY-METHYL) - NAPHTHALEN-2-YL-METHYL] -AMMONIUM CHLORIDE FOR USE IN THE TREATMENT OF MUSCULAR DYSTROPHY.) | ⤷ Subscribe |
| Colombia | 2018003971 | ⤷ Subscribe | |
| Brazil | 112018008870 | ⤷ Subscribe | |
| Croatia | P20210747 | ⤷ Subscribe | |
| Taiwan | I727983 | ⤷ Subscribe | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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