Illuccix Generic: When Will Generic Gallium Ga-68 Gozetotide Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Illuccix Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? July 2035 About 9 years away Why then?
  2. Has the FDA approved a generic? May 2026 2 companies approved
  3. When does the last patent end? July 2035 Its only patent listed with the FDA
  4. Can you buy a generic today? Yes 1 company lists one

Explains

PharmD, BCPS · Clinical pharmacist Updated

It already is. A generic gallium ga-68 gozetotide is listed for sale by 1 company, so ask your pharmacy whether it can fill your prescription with one.

Why July 2035?

It is when Illuccix’s patent 11,027,031 ends. That patent covers a way of using it, 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 Illuccix, 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.

Illuccix 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 2021 December 2021 FDA Orange Book
  • Patents listed 1 last runs to July 2035 FDA Orange Book
  • Generics FDA-approved 2 companies, the first approved May 2026 FDA Orange Book
  • Medicaid prescriptions 647 in the last four reported quarters, $2.7M CMS Medicaid drug utilization, to Q1 2026

Illuccix’s Road to a Generic

Illuccix has had the market to itself since the FDA approved it in December 2021 (Telix Pharmaceuticals US Inc). Its one listed patent runs to July 2035.

The first generic of Illuccix is expected in July 2035.

Why that month: patent 11,027,031, on a way of using it, ends then.

Brand alone on the market Since FDA approval, December 2021
Patent 11,027,031 Expires July 2035 The patent behind the expected month of generic availability
Brand alone on the market Patent on a use First generic expected Swipe the chart sideways to see every year.

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.

Illuccix Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Illuccix’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 11,027,031, which ends in July 2035, the month the first generic is expected.

Patents listed with the FDA (1)
PatentWhat it coversProtects untilStatus
11,027,031 Sets the expected month of generic availability A way of using it (U-3317) July 2035 Active

Source: FDA Orange Book, application 214032. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Gallium Ga-68 Gozetotide

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.

1

Applied to the FDA

No application count is on record for Illuccix, but the FDA has already approved 2 companies (step 2), and every approval starts with an application.

2

Approved by the FDA

The FDA has approved generic versions from 2 companies, the first in May 2026. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.

3

For Sale in Pharmacies

Yes. A generic gallium ga-68 gozetotide is listed for sale by 1 company. Ask your pharmacy whether it can fill your prescription with it.

Ionetix Corporation

Generic versions the FDA has approved (2 companies)
CompanyFirst approvedStrengthsRated
Ionetix Corp May 20260.5-5mCi/MLAP
Radiomedix Inc June 20260.5-5mCi/MLAP

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).

Illuccix 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 Illuccix, 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.

What Medicare and Medicaid Spend on Illuccix

Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.

Medicaid Prescriptions by Quarter

647 prescriptions in the four quarters to Q1 2026, $2.7M paid.

See the numbers
QuarterPrescriptionsMedicaid paid
Q1 2026108$407,742
Q4 2025180$690,491
Q3 2025187$817,187
Q2 2025172$773,104
Q1 202593$396,818

Source: CMS Medicaid State Drug Utilization Data, over Illuccix’s own package codes.

Illuccix Strengths and Forms

StrengthFormHow it is takenApprovedStatus
N/APowderIntravenousDecember 2021Prescription reference product

Source: FDA Orange Book, Telix Pharmaceuticals US Inc. Listed for sale today by Telix Pharmaceuticals US Inc. and Telix Pharmaceuticals (US) Inc. (FDA NDC Directory).

Illuccix NDC Codes and Packages

Each Illuccix package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.

Illuccix packages (4)
NDCProductPackageCompany
74725-0100-25kit1 KIT in 1 CARTON * 2.5 mL in 1 VIAL, MULTI-DOSE * 6.4 mL in 1 VIAL, MULTI-DOSE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSETelix Pharmaceuticals (US) Inc.
74725-0100-25kit1 KIT in 1 CARTON * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE * 2.5 mL in 1 VIAL, MULTI-DOSE * 6.4 mL in 1 VIAL, MULTI-DOSETelix Pharmaceuticals (US) Inc.
74725-0100-64kit1 KIT in 1 CARTON * 2.5 mL in 1 VIAL, MULTI-DOSE * 6.4 mL in 1 VIAL, MULTI-DOSE * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSETelix Pharmaceuticals (US) Inc.
74725-0100-64kit1 KIT in 1 CARTON * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, MULTI-DOSE * 2.5 mL in 1 VIAL, MULTI-DOSE * 6.4 mL in 1 VIAL, MULTI-DOSETelix Pharmaceuticals (US) Inc.

Source: the FDA NDC Directory, current listings only. Only packages sold under Illuccix’s own FDA approval (NDA 214032) are listed, never a generic. Some codes belong to companies that repackage Illuccix: it is the same medicine in a different package.

What a Generic Illuccix 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 Illuccix

Is there a generic for Illuccix right now?

Yes. The FDA NDC Directory lists a generic gallium ga-68 gozetotide from 1 company. Ask your pharmacy whether it can fill your prescription with it.

When will Illuccix go generic?

It already has. The FDA NDC Directory lists a generic gallium ga-68 gozetotide from 1 company, so ask your pharmacy whether it can fill your prescription with one.

Will generic gallium ga-68 gozetotide be the same as Illuccix?

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. The FDA has already approved 2 companies to make a generic, and how many of them launch decides how far the price falls.

Has the FDA approved a generic Illuccix?

Yes. The FDA Orange Book lists approved generic versions from 2 companies, the first approved in May 2026: Ionetix Corp and Radiomedix Inc. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.

When does the Illuccix patent expire?

One patent is listed for Illuccix in the FDA Orange Book; it runs to July 2035. The one behind the expected month is patent 11,027,031, which ends in July 2035. 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 (July 2035) weighs all of that.

Changes to This Projection

  • First generic expected July 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

All upcoming generics

About Illuccix

  • Generic name gallium ga-68 gozetotide
  • How it is taken Into a vein (IV)
  • Company Telix Pharmaceuticals US 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 I
  • Have a question? A pharmacist answers, free. Ask about Illuccix

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, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.