Hepzato Patent Expiration

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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9707331 Apparatus for removing chemotherapy compounds from blood
Sep, 2034

(9 years from now)

Active
US9314561 Filter and frame apparatus and method of use
Feb, 2034

(9 years from now)

Active
US10195334 Filter and frame apparatus and method of use
Jan, 2033

(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
US10569004 Apparatus for removing chemotherapy compounds from blood
Nov, 2032

(7 years from now)

Active
US10369264 Apparatus for removing chemotherapy compounds from blood
Nov, 2032

(7 years from now)

Active
US10098997 Apparatus for removing chemotherapy compounds from blood
Nov, 2032

(7 years from now)

Active
US11241522 Apparatus for removing chemotherapy compounds from blood
Nov, 2032

(7 years from now)

Active
US11633528 Apparatus for removing chemotherapy compounds from blood
Nov, 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 Hepzato's patents.

Given below is the list of recent legal activities going on the following patents of Hepzato.

Activity Date Patent Number
Patent litigations
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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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


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 Generic API suppliers:

Melphalan Hydrochloride is the generic name for the brand Hepzato. 16 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

Alternative Brands for Hepzato

Hepzato which is used for treating uveal melanoma with unresectable hepatic metastases., has several other brand drugs using the same active ingredient (Melphalan Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name
Acrotech Biopharma
Evomela
Apotex
Ivra


Apart from brand drugs containing the same ingredient, some generics have also been filed for Melphalan Hydrochloride, Hepzato's active ingredient. Check the complete list of approved generic manufacturers for Hepzato





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.

Approval 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