Pluvicto Generic: When Will It 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
Pluvicto Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? September 2041 About 15 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? September 2041 5 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic lutetium lu 177 vipivotide tetraxetan is expected to be available in September 2041, about 15 years away. None is for sale yet.
Why September 2041?
It is when Pluvicto’s patent 12,208,102 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 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 Pluvicto 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.
Pluvicto 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
- $2.0B a yearBlockbuster
- FDA approved 2022 March 2022 FDA Orange Book
- Patents listed 5 last runs to September 2041 FDA Orange Book
Pluvicto’s Road to a Generic
Pluvicto has had the market to itself since the FDA approved it in March 2022 (Novartis Pharmaceuticals Corp). Its FDA protection (new use) runs to July 2029. Its 5 listed patents run to September 2041.
The first generic of Pluvicto is expected in September 2041.
Why that month: patent 12,208,102, on 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.
Pluvicto Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Pluvicto’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 12,208,102, which ends in September 2041, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,406,240 | The active ingredient; the product’s formulation; a way of using it (U-4169, U-4594, U-4593) | August 2028 | Active |
| 11,318,121 | The active ingredient; the product’s formulation; a way of using it (U-4169, U-4594, U-4593) | August 2028 | Active |
| 11,951,190 | A way of using it (U-4169, U-4594, U-4593) | November 2035 | Active |
| 10,398,791 | The active ingredient; the product’s formulation | March 2036 | Active |
| 12,208,102 Sets the expected month of generic availability | A way of using it (U-4169, U-4592, U-4593) | September 2041 | 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. | March 2027 | Active |
| New use I-965 | Three years of protection for a newly approved use (indication). | March 2028 | Active |
| New use I-996 | Three years of protection for a newly approved use (indication). | July 2029 | Active |
Source: FDA Orange Book, application 215833. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Lutetium Lu 177 Vipivotide Tetraxetan
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 Pluvicto yet.
Approved by the FDA
Not yet. The FDA has not approved a generic lutetium lu 177 vipivotide tetraxetan. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic lutetium lu 177 vipivotide tetraxetan 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).
Pluvicto 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 Pluvicto, 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.
Pluvicto Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 27mCi/ML | Solution | Intravenous | March 2022 | Prescription reference product |
Source: FDA Orange Book, Novartis Pharmaceuticals Corp. Listed for sale today by Advanced Accelerator Applications USA, Inc and Novartis Pharmaceuticals Corporation (FDA NDC Directory).
Pluvicto NDC Codes and Packages
Each Pluvicto 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 |
|---|---|---|---|
| 69488-0010-61 | 27 mCi/mL injection, solution | vial of 7.5 mL | Advanced Accelerator Applications USA, Inc |
| 00078-1217-61 | LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN 27 mCi/mL injection, solution | vial of 7.5 mL | Novartis Pharmaceuticals Corporation |
Source: the FDA NDC Directory, current listings only. Only packages sold under Pluvicto’s own FDA approval (NDA 215833) are listed, never a generic. Some codes belong to companies that repackage Pluvicto: it is the same medicine in a different package.
What a Generic Pluvicto Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Pluvicto 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 Pluvicto”. 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 Pluvicto
Is there a generic for Pluvicto right now?
No. As of October 9, 2026 no generic lutetium lu 177 vipivotide tetraxetan is listed for sale in the FDA NDC Directory.
When will Pluvicto go generic?
September 2041 is the expected month, and that is probable but not certain. It is when Pluvicto’s patent 12,208,102 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.
Will generic lutetium lu 177 vipivotide tetraxetan be the same as Pluvicto?
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 Pluvicto?
Not yet. The FDA Orange Book lists no approved generic version of Pluvicto.
When does the Pluvicto patent expire?
The FDA Orange Book lists 5 patents for Pluvicto; the last runs to September 2041. The one behind the expected month is patent 12,208,102, which ends in September 2041. 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 (September 2041) weighs all of that.
Changes to This Projection
- First generic expected September 2041 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
- VistogardUridine TriacetateAugust 2027
- InvokametCanagliflozin and Metformin HydrochlorideJanuary to June 2028
- DovatoDolutegravir Sodium and Lamivudine2029 to 2030
- SeglentisCelecoxib and Tramadol HydrochlorideApril 2030
- NuplazidPimavanserin TartrateSeptember 2036
- AmbelvistGadoquatrane2039 to 2040
About Pluvicto
- Generic name lutetium lu 177 vipivotide tetraxetan
- How it is taken Into a vein (IV)
- Company Novartis Pharmaceuticals Corp
- 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 P
- Have a question? A pharmacist answers, free. Ask about Pluvicto
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.