Cytalux Generic: When Will Generic Pafolacianine 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
Cytalux Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? November 2035 About 9 years away Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? November 2035 6 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic pafolacianine sodium is expected to be available in November 2035, about 9 years away. None is for sale yet.
Why November 2035?
It is when Cytalux’s patent 9,061,057 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Cytalux as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Cytalux by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2021 November 2021 FDA Orange Book
- Patents listed 6 last runs to November 2035 FDA Orange Book
Cytalux’s Road to a Generic
Cytalux has had the market to itself since the FDA approved it in November 2021 (On Target Laboratories Inc). Its FDA protection (orphan drug) runs to November 2028. Its 6 listed patents run to November 2035.
The first generic of Cytalux is expected in November 2035.
Why that month: patent 9,061,057, on the active ingredient, the product’s formulation and a way of using it, 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.
Cytalux Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Cytalux’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 9,061,057, which ends in November 2035, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,333,270 | The active ingredient; the product’s formulation; a way of using it (U-3291) | August 2033 | Active |
| 9,341,629 | The active ingredient; the product’s formulation | August 2033 | Active |
| 9,789,208 | The active ingredient; the product’s formulation; a way of using it (U-3291) | August 2033 | Active |
| 10,881,747 | The active ingredient; the product’s formulation; a way of using it (U-3291) | August 2033 | Active |
| 9,254,341 | The active ingredient; the product’s formulation | October 2033 | Active |
| 9,061,057 Sets the expected month of generic availability | The active ingredient; the product’s formulation; a way of using it (U-3291) | November 2035 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | November 2026 | Active |
| Orphan drug ODE-390 | Seven years of protection for a use in a rare disease. | November 2028 | Active |
Source: FDA Orange Book, application 214907. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Pafolacianine Sodium
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 Cytalux yet.
Approved by the FDA
Not yet. The FDA has not approved a generic pafolacianine sodium. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic pafolacianine sodium for sale with the FDA.
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).
Cytalux 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 Cytalux, 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.
Cytalux Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) | Solution | Intravenous | November 2021 | Prescription reference product |
Source: FDA Orange Book, On Target Laboratories Inc. Listed for sale today by On Target Laboratories, Inc. (FDA NDC Directory).
Cytalux NDC Codes and Packages
Each Cytalux 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.
| NDC | Product | Package | Company |
|---|---|---|---|
| 81052-0138-10 | PAFOLACIANINE SODIUM 3.2 mg/1.6mL injection | carton of 10 cartons of 1 vial of 1.6 mL | On Target Laboratories, Inc. |
| 81052-0138-10 | PAFOLACIANINE SODIUM 3.2 mg/1.6mL injection | carton of 10 cartons of 1 vial of 1.6 mL | On Target Laboratories, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Cytalux’s own FDA approval (NDA 214907) are listed, never a generic. Some codes belong to companies that repackage Cytalux: it is the same medicine in a different package.
What a Generic Cytalux Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Cytalux as usual. When one arrives, there is nothing you need to sign up for.
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.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Cytalux”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Cytalux
Is there a generic for Cytalux right now?
No. As of October 9, 2026 no generic pafolacianine sodium is listed for sale in the FDA NDC Directory.
When will Cytalux go generic?
November 2035 is the expected month, and that is probable but not certain. It is when Cytalux’s patent 9,061,057 ends. That patent covers the active ingredient, the product’s formulation and a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic pafolacianine sodium be the same as Cytalux?
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 Cytalux?
Not yet. The FDA Orange Book lists no approved generic version of Cytalux.
When does the Cytalux patent expire?
The FDA Orange Book lists 6 patents for Cytalux; the last runs to November 2035. The one behind the expected month is patent 9,061,057, which ends in November 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 (November 2035) weighs all of that.
Changes to This Projection
- First generic expected November 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
- BeleodaqBelinostat2026 to 2027
- KyprolisCarfilzomibDuring 2027
- TadliqTadalafil2030 to 2031
- XermeloTelotristat EtiprateFebruary 2031
- EvrysdiRisdiplam2036 to 2037
- PalsonifyPaltusotine Hydrochloride2041 to 2042
About Cytalux
- Generic name pafolacianine sodium
- How it is taken Into a vein (IV)
- Company On Target Laboratories Inc
- More drugs Brand-name drugs starting with C
- Have a question? A pharmacist answers, free. Ask about Cytalux
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.