Hepzato is a drug owned by Delcath Systems Inc. It is protected by 10 US drug patents filed in 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 17, 2034. Details of Hepzato's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10098997 | Apparatus for removing chemotherapy compounds from blood |
Nov, 2032
(8 years from now) | Active |
| US11633528 | Apparatus for removing chemotherapy compounds from blood |
Nov, 2032
(8 years from now) | Active |
| US11241522 | Apparatus for removing chemotherapy compounds from blood |
Nov, 2032
(8 years from now) | Active |
| US10369264 | Apparatus for removing chemotherapy compounds from blood |
Nov, 2032
(8 years from now) | Active |
| US10569004 | Apparatus for removing chemotherapy compounds from blood |
Nov, 2032
(8 years from now) | Active |
| US11833286 | Filter and frame apparatus and method of use |
Dec, 2032
(8 years from now) | Active |
| US11083831 | Filter and frame apparatus and method of use |
Dec, 2032
(8 years from now) | Active |
| US10195334 | Filter and frame apparatus and method of use |
Jan, 2033
(8 years from now) | Active |
| US9314561 | Filter and frame apparatus and method of use |
Feb, 2034
(9 years from now) | Active |
| US9707331 | Apparatus for removing chemotherapy compounds from blood |
Sep, 2034
(10 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 Hepzato's patents.
Latest Legal Activities on Hepzato's Patents
Given below is the list of recent legal activities going on the following patents of Hepzato.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Initial letter Re: PTE Application to regulating agency | 25 Apr, 2024 | US10369264 |
| Email Notification | 05 Dec, 2023 | US11833286 |
| Mail Patent eGrant Notification | 05 Dec, 2023 | US11833286 |
| Recordation of Patent eGrant | 05 Dec, 2023 | US11833286 |
| Patent Issue Date Used in PTA Calculation | 05 Dec, 2023 | US11833286 |
| Recordation of Patent Grant Mailed | 05 Dec, 2023 | US11833286 |
| Patent eGrant Notification | 05 Dec, 2023 | US11833286 |
| Email Notification | 16 Nov, 2023 | US11833286 |
| Issue Notification Mailed | 15 Nov, 2023 | US11833286 |
| Application Is Considered Ready for Issue | 26 Oct, 2023 | US11833286 |
FDA has granted several exclusivities to Hepzato. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Hepzato, 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 Hepzato.
Exclusivity Information
Hepzato holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Hepzato's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Aug 14, 2026 |
| Orphan Drug Exclusivity(ODE-438) | Aug 14, 2030 |
US patents provide insights into the exclusivity only within the United States, but Hepzato 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 Hepzato's family patents as well as insights into ongoing legal events on those patents.
Hepzato's family patents
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Generic Launch
Generic Release Date:
Hepzato's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 17, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Hepzato Generics:
Melphalan Hydrochloride is the generic name for the brand Hepzato. 15 different companies have already filed for the generic of Hepzato, with Mylan Institutional having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Hepzato's generic
About Hepzato
Hepzato is a drug owned by Delcath Systems Inc. It is used for treating uveal melanoma with unresectable hepatic metastases. Hepzato uses Melphalan Hydrochloride as an active ingredient. Hepzato was launched by Delcath Systems Inc in 2023.
Market Authorisation Date:
Hepzato was approved by FDA for market use on 14 August, 2023.
Active Ingredient:
Hepzato uses Melphalan Hydrochloride as the active ingredient. Check out other Drugs and Companies using Melphalan Hydrochloride ingredient
Treatment:
Hepzato is used for treating uveal melanoma with unresectable hepatic metastases.
Dosage:
Hepzato is available in powder form for intra-arterial use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE/VIAL | POWDER | Prescription | INTRA-ARTERIAL |