Tafinlar Generic: When Will Generic Dabrafenib 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
Tafinlar Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July 2030 About 4 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 2038 7 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 dabrafenib mesylate is expected to be available in July 2030, about 4 years away, first for Tafinlar tablet for oral suspension. None is for sale yet. Each product has its own month below.
Why July 2030?
It is when Tafinlar’s patents 7,994,185 and 8,415,345 end. They cover the active ingredient, the product’s formulation and a way of using it, and once they end, 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 Tafinlar’s last patent runs to December 2038, how can a generic come sooner?
The 4 patents that run past the expected month, to December 2038 (8,703,781, 8,952,018, 10,869,869 and 11,504,333), cover the active ingredient, the product’s formulation and a way of using it. 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. Its FDA protection (pediatric) also runs past the expected month, to September 2030. The FDA lists when a protection like that ends, but the companies’ own plans and agreements decide when a generic actually launches. Generic companies have been challenging Tafinlar’s patents with the FDA since November 2025. 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 Tafinlar 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
- capsule2030 to 2031Probable · settlement expected
- tablet for oral suspensionJuly 2030Probable · patent expires
Our month is only an estimate based on available information, so we never name a day.
Tafinlar 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
- $549M a yearBig seller, all 2 products
- FDA approved 2013 May 2013 FDA Orange Book
- Patents listed 7 last runs to December 2038 A generic is expected sooner, in July 2030. See why FDA Orange Book
- Medicare Part D spent $255.2M in 2025, for 3,309 people CMS Part D Spending by Drug
- Medicaid prescriptions 2,605 in the last four reported quarters, $37M CMS Medicaid drug utilization, to Q1 2026
Tafinlar’s Road to a Generic
Tafinlar has had the market to itself since the FDA approved it in May 2013 (Novartis Pharmaceuticals Corp). Its FDA protection (pediatric) runs to September 2030. Its 7 listed patents run to December 2038. Generic companies have challenged its patents with the FDA since November 2025.
The first generic of Tafinlar is expected in July 2030.
Why that month: patents 7,994,185 and 8,415,345, on the active ingredient, the product’s formulation and a way of using it, end then. That is about 8.5 years before the last listed patent runs out, in December 2038.
Why a Generic Can Come Before December 2038
The last listed patent runs to December 2038; 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.
Tafinlar Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Tafinlar’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: patents 7,994,185 and 8,415,345, which end in July 2030, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 9,233,956 | A way of using it (U-2032, U-2296, U-1811, U-2031) | November 2029 with the pediatric extension | Active |
| 7,994,185 Sets the expected month of generic availability | The active ingredient; the product’s formulation; a way of using it (U-2296, U-2032, U-1406, U-2031) | July 2030 with the pediatric extension | Active |
| 8,415,345 Sets the expected month of generic availability | The active ingredient; the product’s formulation; a way of using it (U-2032, U-2031, U-1406, U-2296) | July 2030 with the pediatric extension | Active |
| 8,703,781 | The active ingredient; the product’s formulation; a way of using it (U-2296, U-1713, U-2298, U-2032, U-3565) | April 2031 with the pediatric extension | Active |
| 8,952,018 | A way of using it (U-2027) | April 2031 with the pediatric extension | Active |
| 10,869,869 | A way of using it (U-3185) | February 2034 with the pediatric extension | Active |
| 11,504,333 | The product’s formulation | December 2038 with the pediatric extension | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New use I-908 | Three years of protection for a newly approved use (indication). | March 2026 | Ended |
| New product NP | Three years of protection for a change that needed new clinical studies. | March 2026 | Ended |
| Orphan drug ODE-428 | Seven years of protection for a use in a rare disease. | March 2030 | Active |
| Pediatric PED | Six more months, earned by studying the medicine in children. | September 2030 | Active |
Source: FDA Orange Book, application 202806, 217514. Patent numbers open the patent on Google Patents.
Patent Challenges to Tafinlar
The first patent challenge to Tafinlar reached the FDA in November 2025, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Tafinlar’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Capsules, 50 mg and 75 mg | November 2025 | 1 company | No decision yet | Not yet | Not yet | October 2030 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Dabrafenib Mesylate
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 Tafinlar yet.
Generic companies have challenged Tafinlar’s patents with the FDA since November 2025: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic dabrafenib mesylate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic dabrafenib mesylate 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).
Tafinlar 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 Tafinlar, 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 Tafinlar
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 Tafinlar, before manufacturer rebates.
- $70M
- January to March 2026, the latest CMS has posted
For 2,144 people, about $14,785 per prescription fill - $255.2M
- 2025, the whole year
For 3,309 people, about $13,965 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $70,021,074 | 2,144 | $14,784.86 |
| 2025 | $255,225,973 | 3,309 | $13,965.09 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Tafinlar only, so no generic is counted in it. What CMS says it is used for: Dabrafenib is used to treat various cancers (such as skin, thyroid, lung, solid tumors, brain). It belongs to a class of drugs known as kinase inhibitors.
Medicaid Prescriptions by Quarter
2,605 prescriptions in the four quarters to Q1 2026, $37M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 619 | $9,257,477 |
| Q4 2025 | 634 | $8,792,850 |
| Q3 2025 | 677 | $9,543,003 |
| Q2 2025 | 675 | $9,367,582 |
| Q1 2025 | 724 | $9,627,877 |
Source: CMS Medicaid State Drug Utilization Data, over Tafinlar’s own package codes.
Tafinlar Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 50MG BASE | Capsule | Oral | May 2013 | Prescription reference product |
| EQ 75MG BASE | Capsule | Oral | May 2013 | Prescription reference product |
| EQ 10MG BASE | Tablet, for suspension | Oral | March 2023 | Prescription reference product |
Source: FDA Orange Book, Novartis Pharmaceuticals Corp. Listed for sale today by Novartis Pharmaceuticals Corporation (FDA NDC Directory).
Tafinlar NDC Codes and Packages
Each Tafinlar 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 |
|---|---|---|---|
| 00078-1154-21 | DABRAFENIB MESYLATE 10 mg/1 tablet, for suspension | bottle of 210 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1154-21 | DABRAFENIB MESYLATE 10 mg/1 tablet, for suspension | bottle of 210 tablets | Novartis Pharmaceuticals Corporation |
| 00078-0682-66 | DABRAFENIB MESYLATE 50 mg/1 capsule | bottle of 120 capsules | Novartis Pharmaceuticals Corporation |
| 00078-0682-66 | DABRAFENIB MESYLATE 50 mg/1 capsule | bottle of 120 capsules | Novartis Pharmaceuticals Corporation |
| 00078-0681-66 | DABRAFENIB MESYLATE 75 mg/1 capsule | bottle of 120 capsules | Novartis Pharmaceuticals Corporation |
| 00078-0681-66 | DABRAFENIB MESYLATE 75 mg/1 capsule | bottle of 120 capsules | Novartis Pharmaceuticals Corporation |
Source: the FDA NDC Directory, current listings only. Only packages sold under Tafinlar’s own FDA approval (NDA 202806, NDA 217514) are listed, never a generic. Some codes belong to companies that repackage Tafinlar: it is the same medicine in a different package.
What a Generic Tafinlar Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Tafinlar 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 Tafinlar”. 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 Tafinlar
Is there a generic for Tafinlar right now?
No. As of October 9, 2026 no generic dabrafenib mesylate is listed for sale in the FDA NDC Directory.
When will Tafinlar go generic?
July 2030 is the expected month, and that is probable but not certain. It is when Tafinlar’s patents 7,994,185 and 8,415,345 end. They cover the active ingredient, the product’s formulation and a way of using it, and once they end, generics should be able to go on sale as soon as the FDA approves them. The last listed patent runs to December 2038; a court ruling or a settlement can bring a generic sooner.
Will generic dabrafenib mesylate be the same as Tafinlar?
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 Tafinlar?
Not yet. The FDA Orange Book lists no approved generic version of Tafinlar.
When does the Tafinlar patent expire?
The FDA Orange Book lists 7 patents for Tafinlar; the last runs to December 2038, counting a six-month pediatric extension. The one behind the expected month is patents 7,994,185 and 8,415,345, which end in July 2030. 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 (July 2030) weighs all of that.
Has anyone challenged the Tafinlar patents?
Yes. The first patent challenge to Tafinlar reached the FDA in November 2025, from one company on that first day. The FDA has not approved a first challenger’s generic yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
Changes to This Projection
- First generic expected July 2030 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
- VelphoroFerric OxyhydroxideDuring 2026
- ImvexxyEstradiolDuring 2032
- RiViveNaloxone HydrochlorideMay 2032
- NexletolBempedoic AcidDuring 2033
- AdqueyDifamilast2037 to 2038
- DefinityPerflutrenMay 2037
About Tafinlar
- Generic name dabrafenib mesylate
- How it is taken By mouth
- Company Novartis Pharmaceuticals Corp
- Hard to copy Inhalers, injectables, patches and other hard-to-copy products. Fewer companies attempt them and dates slip more often.
- Patent challenges Since November 2025 (FDA)
- More drugs Brand-name drugs starting with T
- Have a question? A pharmacist answers, free. Ask about Tafinlar
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 Paragraph IV Patent Certifications list, 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.