Duvyzat is a drug owned by Italfarmaco Spa. It is protected by 4 US drug patents filed in 2024 out of which none have expired yet. Duvyzat's patents will be open to challenges from 21 March, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 28, 2036. Details of Duvyzat's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7329689 | Monohydrate hydrochloride of the 4-hydroxycarbamoyl-phenyl)-carbamic acid (6-diethylaminomethyl-naphtalen-2-yl) ester |
Jan, 2025
(a month from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10688047 | Physically and chemically stable oral suspensions of givinostat |
Oct, 2036
(11 years from now) | Active |
| US9421184 | Diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride for use in the treatment of muscular dystrophy |
Feb, 2032
(7 years from now) | Active |
| US9867799 | Diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride for use in the treatment of muscular dystrophy |
Feb, 2032
(7 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Duvyzat's patents.
Latest Legal Activities on Duvyzat's Patents
Given below is the list of recent legal activities going on the following patents of Duvyzat.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Term Extension Application under 35 USC 156 Filed | 17 May, 2024 | US9421184 |
| Patent Term Extension Application under 35 USC 156 Filed | 17 May, 2024 | US10688047 |
| Patent Term Extension Application under 35 USC 156 Filed | 17 May, 2024 | US9867799 |
| Patent Term Extension Application under 35 USC 156 Filed | 17 May, 2024 | US7329689 |
| Email Notification Critical | 15 May, 2024 | US9867799 |
| Change in Power of Attorney (May Include Associate POA) Critical | 15 May, 2024 | US9421184 |
| Email Notification Critical | 15 May, 2024 | US9421184 |
| Change in Power of Attorney (May Include Associate POA) Critical | 15 May, 2024 | US9867799 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Feb, 2024 | US9421184 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Dec, 2023 | US10688047 |
FDA has granted several exclusivities to Duvyzat. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Duvyzat, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Duvyzat.
Exclusivity Information
Duvyzat holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Duvyzat's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 21, 2029 |
| Orphan Drug Exclusivity(ODE-473) | Mar 21, 2031 |
US patents provide insights into the exclusivity only within the United States, but Duvyzat is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Duvyzat's family patents as well as insights into ongoing legal events on those patents.
Duvyzat's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Duvyzat's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 28, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Duvyzat Generics:
There are no approved generic versions for Duvyzat as of now.
About Duvyzat
Duvyzat is a drug owned by Italfarmaco Spa. Duvyzat uses Givinostat Hydrochloride as an active ingredient. Duvyzat was launched by Italfarmaco Spa in 2024.
Approval Date:
Duvyzat was approved by FDA for market use on 21 March, 2024.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Duvyzat is 21 March, 2024, its NCE-1 date is estimated to be 21 March, 2028.
Active Ingredient:
Duvyzat uses Givinostat Hydrochloride as the active ingredient. Check out other Drugs and Companies using Givinostat Hydrochloride ingredient
Dosage:
Duvyzat is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 8.86MG BASE/ML | SUSPENSION | Prescription | ORAL |