Caprelsa Generic: When Will Generic Vandetanib 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

Caprelsa Generic at a Glance

Four quick answers from FDA records and our estimate.

When is the first generic expected? August 2028 About 2 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? August 2028 Its only patent listed with the FDA
Can you buy a generic today? Not yet No company lists one for sale

Dr. Brian Staiger Explains

PharmD, BCPS · Clinical pharmacist Updated October 9, 2026

Generic vandetanib is expected to be available in August 2028, about 2 years away. None is for sale yet.

Why August 2028?

It is when Caprelsa’s patent 8,067,427 ends. That patent covers the product’s formulation, 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 Caprelsa 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.

Caprelsa 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: $11M a yearSmaller seller

FDA approved 2011 April 2011 FDA Orange Book
Patents listed 1 last runs to August 2028 FDA Orange Book
Medicare Part D spent $3.7M in 2025, for 31 people CMS Part D Spending by Drug

Caprelsa’s Road to a Generic

Caprelsa has had the market to itself since the FDA approved it in April 2011 (Genzyme Corp). Its one listed patent runs to August 2028.

The first generic of Caprelsa is expected in August 2028.

Why that month: patent 8,067,427, on the product’s formulation, ends then.

Brand alone on the market Since FDA approval, April 2011

Patent 8,067,427 Expires August 2028 The patent behind the expected month of generic availability

Brand alone on the market Patent on the formulation 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.

Caprelsa Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Caprelsa’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 8,067,427, which ends in August 2028, the month the first generic is expected.

Patents listed with the FDA (1)
Patent	What it covers	Protects until	Status
8,067,427 Sets the expected month of generic availability	The product’s formulation	August 2028	Active

Source: FDA Orange Book, application 022405. Patent numbers open the patent on Google Patents.

Who Is Lined Up to Make Generic Vandetanib

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 Caprelsa yet.

Approved by the FDA

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

For Sale in Pharmacies

Not yet. No company lists a generic vandetanib 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).

Caprelsa 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 Caprelsa, 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).

Brandbefore generics

1 makerabout 31% less

2 makersabout 44% less

4 makersabout 73% less

6+ makersover 95% less

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 Caprelsa

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.

Medicare Part D Spending

What Medicare drug plans spent on Caprelsa, before manufacturer rebates.

$739.3K: January to March 2026, the latest CMS has posted
For 20 people, about $16,430 per prescription fill
$3.7M: 2025, the whole year
For 31 people, about $17,066 per prescription fill

See the numbers

Period	Spending	People	Per fill
January to March 2026	$739,339	20	$16,429.77
2025	$3,737,354	31	$17,065.54

Source: CMS Medicare Part D Spending by Drug, matched by the brand name Caprelsa only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat thyroid cancer (medullary type). It works by slowing or stopping the growth of cancer cells.

Caprelsa Strengths and Forms

Strength	Form	How it is taken	Approved	Status
100MG	Tablet	Oral	April 2011	Prescription reference product
300MG	Tablet	Oral	April 2011	Prescription reference product

Source: FDA Orange Book, Genzyme Corp. Listed for sale today by Genzyme Corporation (FDA NDC Directory).

Caprelsa NDC Codes and Packages

Each Caprelsa 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.

Caprelsa packages (4)
NDC	Product	Package	Company
58468-7820-03	VANDETANIB 100 mg/1 tablet, film coated	bottle of 30 tablets	Genzyme Corporation
58468-7820-03	VANDETANIB 100 mg/1 tablet, film coated	bottle of 30 tablets	Genzyme Corporation
58468-7840-03	VANDETANIB 300 mg/1 tablet, film coated	bottle of 30 tablets	Genzyme Corporation
58468-7840-03	VANDETANIB 300 mg/1 tablet, film coated	bottle of 30 tablets	Genzyme Corporation

Source: the FDA NDC Directory, current listings only. Only packages sold under Caprelsa’s own FDA approval (NDA 22405) are listed, never a generic. Some codes belong to companies that repackage Caprelsa: it is the same medicine in a different package.

What a Generic Caprelsa Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Caprelsa 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 Caprelsa”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.

Ask a pharmacist about Caprelsa Vandetanib drug page

Questions people ask about Caprelsa

Is there a generic for Caprelsa right now?

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

When will Caprelsa go generic?

August 2028 is the expected month, and that is toss-up but not certain. It is when Caprelsa’s patent 8,067,427 ends. That patent covers the product’s formulation, and once it ends, generics can go on sale as soon as the FDA approves them.

Will generic vandetanib be the same as Caprelsa?

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 Caprelsa?

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

When does the Caprelsa patent expire?

One patent is listed for Caprelsa in the FDA Orange Book; it runs to August 2028. The one behind the expected month is patent 8,067,427, which ends in August 2028. 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 (August 2028) weighs all of that.

Changes to This Projection

October 2026First generic expected August 2028 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 Caprelsa

Generic name vandetanib
How it is taken By mouth
Company Genzyme 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 C
Have a question? A pharmacist answers, free. Ask about Caprelsa

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, CMS Medicare Part D Spending by Drug, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.