Posluma Generic: When Will Generic Flotufolastat F 18 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
Posluma Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? November 2038 About 12 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 2041 6 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic flotufolastat f 18 is expected to be available in November 2038, about 12 years away. None is for sale yet.
Why November 2038?
It is when Posluma’s patent 11,413,360 ends. That patent covers the active ingredient and a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. We rate it probable: more likely than not, but it can still move.
If Posluma’s last patent runs to November 2041, how can a generic come sooner?
The 2 patents that run past the expected month, to November 2041 (12,036,290 and 12,427,207), cover the product’s formulation and a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. That is why the expected month comes before the last protection ends. See the road to a generic
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 Posluma 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.
Posluma 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 2023 May 2023 FDA Orange Book
- Patents listed 6 last runs to November 2041 A generic is expected sooner, in November 2038. See why FDA Orange Book
Posluma’s Road to a Generic
Posluma has had the market to itself since the FDA approved it in May 2023 (Blue Earth Diagnostics Ltd). Its FDA protection (new chemical entity) runs to May 2028. Its 6 listed patents run to November 2041.
The first generic of Posluma is expected in November 2038.
Why that month: patent 11,413,360, on the active ingredient and a way of using it, ends then. That is about 3 years before the last listed patent runs out, in November 2041.
Why a Generic Can Come Before November 2041
The last listed patent runs to November 2041, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
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.
Posluma Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Posluma’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 11,413,360, which ends in November 2038, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 12,390,540 | The active ingredient | August 2038 | Active |
| 11,413,360 Sets the expected month of generic availability | The active ingredient; a way of using it (U-3614, U-3615) | November 2038 | Active |
| 12,357,711 | The active ingredient | November 2038 | Active |
| 12,377,176 | The active ingredient | November 2038 | Active |
| 12,036,290 | The product’s formulation; a way of using it (U-3614, U-3615) | November 2041 | Active |
| 12,427,207 | The product’s formulation | November 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. | May 2028 | Active |
Source: FDA Orange Book, application 216023. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Flotufolastat F 18
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 Posluma yet.
Approved by the FDA
Not yet. The FDA has not approved a generic flotufolastat f 18. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic flotufolastat f 18 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).
Posluma 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 Posluma, 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.
Posluma Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 25ML (8-158mCi/ML) | Solution | Intravenous | May 2023 | Prescription reference product |
Source: FDA Orange Book, Blue Earth Diagnostics Ltd. Listed for sale today by Blue Earth Diagnostics (FDA NDC Directory).
Posluma NDC Codes and Packages
Each Posluma 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 |
|---|---|---|---|
| 69932-0002-50 | FLOTUFOLASTAT F-18 158 mCi/mL injection | vial of 25 mL | Blue Earth Diagnostics |
| 69932-0002-50 | FLOTUFOLASTAT F-18 158 mCi/mL injection | vial of 25 mL | Blue Earth Diagnostics |
Source: the FDA NDC Directory, current listings only. Only packages sold under Posluma’s own FDA approval (NDA 216023) are listed, never a generic. Some codes belong to companies that repackage Posluma: it is the same medicine in a different package.
What a Generic Posluma Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Posluma 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 Posluma”. 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 Posluma
Is there a generic for Posluma right now?
No. As of October 9, 2026 no generic flotufolastat f 18 is listed for sale in the FDA NDC Directory.
When will Posluma go generic?
November 2038 is the expected month, and that is probable but not certain. It is when Posluma’s patent 11,413,360 ends. That patent covers the active ingredient and a way of using it, and once it ends, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to November 2041, but it covers the product’s formulation and a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic flotufolastat f 18 be the same as Posluma?
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 Posluma?
Not yet. The FDA Orange Book lists no approved generic version of Posluma.
When does the Posluma patent expire?
The FDA Orange Book lists 6 patents for Posluma; the last runs to November 2041. The one behind the expected month is patent 11,413,360, which ends in November 2038. 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 2038) weighs all of that.
Changes to This Projection
- First generic expected November 2038 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
- VivitrolNaltrexoneJanuary 2027
- Duaklir PressairAclidinium Bromide and Formoterol FumarateMarch 2029
- IonsysFentanyl HydrochlorideFebruary 2033
- AmvuttraVutrisiran SodiumJuly 2036
- SephienceSepiapterin2037 to 2038
- NuzolvenceZoliflodacinJanuary 2039
About Posluma
- Generic name flotufolastat f 18
- How it is taken Into a vein (IV)
- Company Blue Earth Diagnostics Ltd
- 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 Posluma
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.