Hepzato Generic: When Will Generic Melphalan Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Hepzato Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2035 About 8.5 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet
- When does the last patent end? September 2034 10 patents listed with the FDA
- Can you buy a generic today? Yes 18 companies list one
It already is. A generic melphalan is listed for sale by 18 companies, so ask your pharmacy whether it can fill your prescription with one.
Why February 2035?
It is when Hepzato’s patent 10,369,264 ends. That patent covers the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Hepzato, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Hepzato by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2023 August 2023 FDA Orange Book
- Patents listed 10 last runs to September 2034 FDA Orange Book
Hepzato’s Road to a Generic
Hepzato has had the market to itself since the FDA approved it in August 2023 (Delcath Systems Inc). Its FDA protection (orphan drug) runs to August 2030. Its 10 listed patents run to September 2034.
The first generic of Hepzato is expected in February 2035.
Why that month: patent 10,369,264, on the product’s formulation, ends then.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Hepzato Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Hepzato’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
The one that matters for a generic launch: patent 10,369,264, which ends in November 2032; the first generic is expected after it, in February 2035, about 8.5 years away.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,098,997 | The product’s formulation | November 2032 | Active |
| 10,369,264 Sets the expected month of generic availability | The product’s formulation | November 2032 | Active |
| 10,569,004 | A way of using it (U-3680, U-3683) | November 2032 | Active |
| 11,241,522 | The product’s formulation | November 2032 | Active |
| 11,633,528 | A way of using it (U-3675) | November 2032 | Active |
| 11,083,831 | The product’s formulation | December 2032 | Active |
| 11,833,286 | The product’s formulation | December 2032 | Active |
| 10,195,334 | The product’s formulation | January 2033 | Active |
| 9,314,561 | The product’s formulation | February 2034 | Active |
| 9,707,331 | The product’s formulation | September 2034 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New product NP | Three years of protection for a change that needed new clinical studies. | August 2026 | Ended |
| Orphan drug ODE-438 | Seven years of protection for a use in a rare disease. | August 2030 | Active |
Source: FDA Orange Book, application 201848. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Melphalan
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
No company is recorded as having applied to the FDA to make a generic Hepzato yet.
Approved by the FDA
Not yet. The FDA has not approved a generic melphalan. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Yes. A generic melphalan is listed for sale by 18 companies. Ask your pharmacy whether it can fill your prescription with it.
Actavis Pharma, Inc., Almaject, Inc., Arthur Group LLC, Athenex Pharmaceutical Division, LLC., Avenacy Inc., BPI Labs LLC and 12 more
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Hepzato Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Hepzato, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017).
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
Hepzato Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 50MG BASE/VIAL | Powder | Intra-arterial | August 2023 | Prescription reference product |
Source: FDA Orange Book, Delcath Systems Inc.
What a Generic Hepzato Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Questions people ask about Hepzato
Is there a generic for Hepzato right now?
Yes. The FDA NDC Directory lists a generic melphalan from 18 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Hepzato go generic?
It already has. The FDA NDC Directory lists a generic melphalan from 18 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic melphalan be the same as Hepzato?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Hepzato?
Not yet. The FDA Orange Book lists no approved generic version of Hepzato.
When does the Hepzato patent expire?
The FDA Orange Book lists 10 patents for Hepzato; the last runs to September 2034. The one behind the expected month is patent 10,369,264, which ends in November 2032. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected month on this page (February 2035) weighs all of that.
Changes to This Projection
- First generic expected February 2035 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- AveedTestosterone UndecanoateMay 2027
- KerendiaFinerenoneAugust 2033
- OrserduElacestrant Hydrochloride2035 to 2037
- XacduroDurlobactam and SulbactamNovember 2035
- EpidiolexCannabidiol2038 to 2039
- SunosiSolriamfetol HydrochlorideDuring 2040
About Hepzato
- Generic name melphalan
- How it is taken Into a vein (IV)
- Company Delcath Systems Inc
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- More drugs Brand-name drugs starting with H
- Have a question? A pharmacist answers, free. Ask about Hepzato
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.