Zelboraf Generic: When Will Generic Vemurafenib 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
Zelboraf Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? June 2029 About 2.5 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? June 2032 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 vemurafenib is expected to be available in June 2029, about 2.5 years away. None is for sale yet.
Why June 2029?
It is when Zelboraf’s patent 7,863,288 ends. That patent covers the active ingredient and the product’s formulation, and once it ends, generics should be able to 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.
If Zelboraf’s last patent runs to June 2032, how can a generic come sooner?
The 2 patents that run past the expected month, to June 2032 (8,741,920 and 9,447,089), cover the active ingredient and the product’s formulation. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. 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 Zelboraf 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.
Zelboraf 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
- $34M a yearSmaller seller
- FDA approved 2011 August 2011 FDA Orange Book
- Patents listed 6 last runs to June 2032 A generic is expected sooner, in June 2029. See why FDA Orange Book
- Medicare Part D spent $17.3M in 2025, for 407 people CMS Part D Spending by Drug
- Medicaid prescriptions 24 in the last four reported quarters, $94.5K CMS Medicaid drug utilization, to Q1 2026
Zelboraf’s Road to a Generic
Zelboraf has had the market to itself since the FDA approved it in August 2011 (Hoffmann La Roche Inc). Its 6 listed patents run to June 2032 (2 already expired).
The first generic of Zelboraf is expected in June 2029.
Why that month: patent 7,863,288, on the active ingredient and the product’s formulation, ends then. That is about 3 years before the last listed patent runs out, in June 2032.
Why a Generic Can Come Before June 2032
The last listed patent runs to June 2032; a court ruling or a settlement can bring a generic sooner. 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.
Zelboraf Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Zelboraf’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 7,863,288, which ends in June 2029, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,143,271 | The active ingredient; the product’s formulation | June 2026 | Expired |
| 8,470,818 | A way of using it (U-2164, U-1418) | August 2026 | Expired |
| 7,504,509 | The active ingredient; the product’s formulation | October 2026 | Active |
| 7,863,288 Sets the expected month of generic availability | The active ingredient; the product’s formulation | June 2029 | Active |
| 8,741,920 | The active ingredient; the product’s formulation | July 2030 | Active |
| 9,447,089 | The product’s formulation | June 2032 | Active |
Source: FDA Orange Book, application 202429. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Vemurafenib
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 Zelboraf yet.
Approved by the FDA
Not yet. The FDA has not approved a generic vemurafenib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic vemurafenib 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).
Zelboraf 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 Zelboraf, 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 Zelboraf
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 Zelboraf, before manufacturer rebates.
- $4M
- January to March 2026, the latest CMS has posted
For 242 people, about $7,821 per prescription fill - $17.3M
- 2025, the whole year
For 407 people, about $7,773 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $3,988,616 | 242 | $7,820.82 |
| 2025 | $17,340,631 | 407 | $7,772.58 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Zelboraf only, so no generic is counted in it. What CMS says it is used for: Vemurafenib is used to treat a type of skin cancer (melanoma). It is also used to treat a rare type of blood cell cancer called Erdheim-Chester disease.
Medicaid Prescriptions by Quarter
24 prescriptions in the four quarters to Q1 2026, $94.5K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 0 | $0 |
| Q4 2025 | 0 | $0 |
| Q3 2025 | 24 | $94,465 |
| Q2 2025 | 0 | $0 |
| Q1 2025 | 0 | $0 |
Source: CMS Medicaid State Drug Utilization Data, over Zelboraf’s own package codes.
Zelboraf Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 240MG | Tablet | Oral | August 2011 | Prescription reference product |
Source: FDA Orange Book, Hoffmann La Roche Inc. Listed for sale today by Genentech, Inc. (FDA NDC Directory).
Zelboraf NDC Codes and Packages
Each Zelboraf 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 |
|---|---|---|---|
| 50242-0090-02 | VEMURAFENIB 240 mg/1 tablet, film coated | bottle of 112 tablets | Genentech, Inc. |
| 50242-0090-02 | VEMURAFENIB 240 mg/1 tablet, film coated | bottle of 112 tablets | Genentech, Inc. |
| 50242-0090-86 | VEMURAFENIB 240 mg/1 tablet, film coated | bottle of 112 tablets | Genentech, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Zelboraf’s own FDA approval (NDA 202429) are listed, never a generic. Some codes belong to companies that repackage Zelboraf: it is the same medicine in a different package.
What a Generic Zelboraf Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Zelboraf 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 Zelboraf”. 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 Zelboraf
Is there a generic for Zelboraf right now?
No. As of October 9, 2026 no generic vemurafenib is listed for sale in the FDA NDC Directory.
When will Zelboraf go generic?
June 2029 is the expected month, and that is toss-up but not certain. It is when Zelboraf’s patent 7,863,288 ends. That patent covers the active ingredient and the product’s formulation, 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 June 2032; a court ruling or a settlement can bring a generic sooner.
Will generic vemurafenib be the same as Zelboraf?
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 Zelboraf?
Not yet. The FDA Orange Book lists no approved generic version of Zelboraf.
When does the Zelboraf patent expire?
The FDA Orange Book lists 6 patents for Zelboraf; the last runs to June 2032. The one behind the expected month is patent 7,863,288, which ends in June 2029. 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 2029) weighs all of that.
Changes to This Projection
- First generic expected June 2029 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
- AplenzinBupropion HydrobromideJuly to December 2026
- Jakafi XRRuxolitinib Phosphate2030 to 2031
- SivextroTedizolid PhosphateDecember 2030
- OlumiantBaricitinibJanuary to June 2032
- VoqueznaVonoprazan Fumarate2033 to 2034
- EkterlySebetralstatMay 2039
About Zelboraf
- Generic name vemurafenib
- How it is taken By mouth
- Company Hoffmann La Roche Inc
- 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 Z
- Have a question? A pharmacist answers, free. Ask about Zelboraf
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, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.