Tauklarify Generic: When Will Generic Florquinitau F18 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

Tauklarify Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? June 2040 About 13.5 years away Why then?
  2. Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
  3. When does the last patent end? June 2035 2 patents listed with the FDA
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist Updated

Generic florquinitau f18 is expected to be available in June 2040, about 13.5 years away. None is for sale yet.

Why June 2040?

It is when Tauklarify’s patent 9,808,542 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 toss-up: still unsettled. Just as likely to slip as to hold.

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 Tauklarify 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.

Tauklarify 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 2026 August 2026 FDA Orange Book
  • Patents listed 2 last runs to June 2035 FDA Orange Book

Tauklarify’s Road to a Generic

Tauklarify has had the market to itself since the FDA approved it in August 2026 (Cerveau Technologies Inc A Lantheus Co). Its FDA protection (new chemical entity) runs to August 2031. Its 2 listed patents run to June 2035.

The first generic of Tauklarify is expected in June 2040.

Why that month: patent 9,808,542, on the active ingredient, the product’s formulation and a way of using it, ends then.

Brand alone on the market Since FDA approval, August 2026
New chemical entity Ends August 2031
Patent 9,808,542 Expires June 2035 The patent behind the expected month of generic availability
Patent 10,022,461 Expires June 2035
Brand alone on the market FDA exclusivity Patent on the active ingredient 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.

Tauklarify Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Tauklarify’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 9,808,542, which ends in June 2035; the first generic is expected after it, in June 2040, about 13.5 years away.

Patents listed with the FDA (2)
PatentWhat it coversProtects untilStatus
9,808,542 Sets the expected month of generic availability The active ingredient; the product’s formulation; a way of using it (U-4597) June 2035 Active
10,022,461 A way of using it (U-4597) June 2035 Active
FDA exclusivities (1)
ExclusivityWhat it meansEndsStatus
New chemical entity NCEFive years of protection for a medicine whose active ingredient the FDA had never approved before.August 2031Active

Source: FDA Orange Book, application 220496. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Florquinitau F18

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 company is recorded as having applied to the FDA to make a generic Tauklarify yet.

2

Approved by the FDA

Not yet. The FDA has not approved a generic florquinitau f18. Final approval often comes close to the day a generic can be sold.

3

For Sale in Pharmacies

Not yet. No company lists a generic florquinitau f18 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).

Tauklarify 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 Tauklarify, 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.

Tauklarify Strengths and Forms

StrengthFormHow it is takenApprovedStatus
1-40mCi/MLSolutionIntravenousAugust 2026Prescription reference product

Source: FDA Orange Book, Cerveau Technologies Inc A Lantheus Co.

What a Generic Tauklarify Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Tauklarify 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 Tauklarify”. 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 Tauklarify

Is there a generic for Tauklarify right now?

No. As of October 9, 2026 no generic florquinitau f18 is listed for sale in the FDA NDC Directory.

When will Tauklarify go generic?

June 2040 is the expected month, and that is toss-up but not certain. It is when Tauklarify’s patent 9,808,542 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 florquinitau f18 be the same as Tauklarify?

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 Tauklarify?

Not yet. The FDA Orange Book lists no approved generic version of Tauklarify.

When does the Tauklarify patent expire?

The FDA Orange Book lists 2 patents for Tauklarify; the last runs to June 2035. The one behind the expected month is patent 9,808,542, which ends in June 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 (June 2040) weighs all of that.

Changes to This Projection

  • First generic expected June 2040 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 Tauklarify

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.