Zykadia Generic: When Will Generic Ceritinib 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
Zykadia Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? February 2032 About 5.5 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? December 2037 8 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 ceritinib is expected to be available in February 2032, about 5.5 years away. None is for sale yet.
Why February 2032?
It is when Zykadia’s patent 8,703,787 ends. That patent covers 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 Zykadia’s last patent runs to December 2037, how can a generic come sooner?
The patent that runs to December 2037 (12,357,630) covers 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 Zykadia 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
- capsuleFebruary 2032Probable · patent expires
- tabletFebruary 2032Probable · patent expires
Our month is only an estimate based on available information, so we never name a day.
Zykadia 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 2014 April 2014 FDA Orange Book
- Patents listed 8 last runs to December 2037 A generic is expected sooner, in February 2032. See why FDA Orange Book
- Medicare Part D spent $4.1M in 2025, for 43 people CMS Part D Spending by Drug
Zykadia’s Road to a Generic
Zykadia has had the market to itself since the FDA approved it in April 2014 (Novartis Pharmaceuticals Corp). Its 8 listed patents run to December 2037 (1 already expired).
The first generic of Zykadia is expected in February 2032.
Why that month: patent 8,703,787, on a way of using it, ends then. That is about 6 years before the last listed patent runs out, in December 2037.
Why a Generic Can Come Before December 2037
The last listed patent runs to December 2037, but it covers 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.
Zykadia Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Zykadia’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 8,703,787, which ends in February 2032, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,893,074 | The active ingredient; the product’s formulation | April 2026 | Expired |
| 8,377,921 | A way of using it (U-1179) | November 2027 | Active |
| 8,399,450 | The active ingredient; the product’s formulation | November 2027 | Active |
| 7,964,592 | The active ingredient; the product’s formulation | April 2028 | Active |
| 8,039,479 | The active ingredient; the product’s formulation | June 2030 | Active |
| 9,309,229 | The active ingredient; the product’s formulation | January 2032 | Active |
| 8,703,787 Sets the expected month of generic availability | A way of using it (U-1179) | February 2032 | Active |
| 12,357,630 | A way of using it (U-3096) | December 2037 | Active |
Source: FDA Orange Book, application 205755, 211225. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Ceritinib
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 Zykadia yet.
Approved by the FDA
Not yet. The FDA has not approved a generic ceritinib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic ceritinib 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).
Zykadia 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 Zykadia, 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.
What Medicare and Medicaid Spend on Zykadia
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 Zykadia, before manufacturer rebates.
- $1.1M
- January to March 2026, the latest CMS has posted
For 32 people, about $12,164 per prescription fill - $4.1M
- 2025, the whole year
For 43 people, about $11,233 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $1,094,741 | 32 | $12,163.79 |
| 2025 | $4,099,896 | 43 | $11,232.59 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Zykadia only, so no generic is counted in it. What CMS says it is used for: Ceritinib is used to treat lung cancer. It is used for lung cancers that have a certain type of abnormal "ALK" gene.
Zykadia Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 150MG | Tablet | Oral | March 2019 | Prescription reference product |
| 150MG | Capsule | Oral | April 2014 | Discontinued reference product |
Source: FDA Orange Book, Novartis Pharmaceuticals Corp. Listed for sale today by Novartis Pharmaceuticals Corporation (FDA NDC Directory).
Zykadia NDC Codes and Packages
Each Zykadia 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 |
|---|---|---|---|
| 00078-0694-48 | CERITINIB 150 mg/1 tablet, film coated | bottle of 21 tablets | Novartis Pharmaceuticals Corporation |
| 00078-0694-48 | CERITINIB 150 mg/1 tablet, film coated | bottle of 21 tablets | Novartis Pharmaceuticals Corporation |
| 00078-0694-84 | CERITINIB 150 mg/1 tablet, film coated | bottle of 84 tablets | Novartis Pharmaceuticals Corporation |
| 00078-0694-84 | CERITINIB 150 mg/1 tablet, film coated | bottle of 84 tablets | Novartis Pharmaceuticals Corporation |
Source: the FDA NDC Directory, current listings only. Only packages sold under Zykadia’s own FDA approval (NDA 205755, NDA 211225) are listed, never a generic. Some codes belong to companies that repackage Zykadia: it is the same medicine in a different package.
What a Generic Zykadia Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Zykadia 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 Zykadia”. 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 Zykadia
Is there a generic for Zykadia right now?
No. As of October 9, 2026 no generic ceritinib is listed for sale in the FDA NDC Directory.
When will Zykadia go generic?
February 2032 is the expected month, and that is probable but not certain. It is when Zykadia’s patent 8,703,787 ends. That patent covers 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 December 2037, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic ceritinib be the same as Zykadia?
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 Zykadia?
Not yet. The FDA Orange Book lists no approved generic version of Zykadia.
When does the Zykadia patent expire?
The FDA Orange Book lists 8 patents for Zykadia; the last runs to December 2037. The one behind the expected month is patent 8,703,787, which ends in February 2032. 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 (February 2032) weighs all of that.
Changes to This Projection
- First generic expected February 2032 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
- EvomelaMelphalan HydrochlorideOctober to December 2026
- SymtuzaCobicistat, Darunavir, Emtricitabine, and Tenofovir AlafenamideDuring 2032
- XcopriCenobamate2035 to 2036
- KrazatiAdagrasibMay 2037
- BarhemsysAmisulprideFebruary 2038
- OtiprioCiprofloxacinNovember 2038
About Zykadia
- Generic name ceritinib
- How it is taken By mouth
- Company Novartis Pharmaceuticals Corp
- More drugs Brand-name drugs starting with Z
- Have a question? A pharmacist answers, free. Ask about Zykadia
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.