Mekinist Generic: When Will Generic Trametinib Dimethyl Sulfoxide 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
Mekinist Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2027 to 2028 A wide window Why then?
- Has the FDA approved a generic? August 2024 Since discontinued Why not yet?
- When does the last patent end? February 2034 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 trametinib dimethyl sulfoxide is expected to be available between 2027 and 2028, first for Mekinist tablet. None is for sale yet. Each product has its own month below.
Why 2027 to 2028?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If Mekinist’s last patent runs to February 2034, how can a generic come sooner?
The 7 patents that run past the expected month, to February 2034 (8,703,781, 8,952,018, 8,580,304, 9,155,706 and 3 more), 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. That protection covers only the use it was granted for, so a generic may be able to launch for other uses and leave that one off its label. Here, a settlement between the companies sets the date. Generic companies have been challenging Mekinist’s patents with the FDA since September 2023. 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, and more so as more companies sell one. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. See the price pattern
What should I do now?
Keep taking Mekinist 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
- tablet2027 to 2028Probable · settlement between companies
- for oral solution2027 to 2029Probable · not yet clear
Our month is only an estimate based on available information, so we never name a day.
Mekinist by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Moderate 3 companies have filed, 1 first in line
- Brand sales
- $674M a yearBig seller, all 2 products
- FDA approved 2013 May 2013 FDA Orange Book
- Patents listed 8 last runs to February 2034 A generic is expected sooner, between 2027 and 2028. See why FDA Orange Book
- Medicare Part D spent $302.2M in 2025, for 3,588 people CMS Part D Spending by Drug
- Medicaid prescriptions 4,772 in the last four reported quarters, $57.1M CMS Medicaid drug utilization, to Q1 2026
Mekinist’s Road to a Generic
Mekinist 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 8 listed patents run to February 2034. Generic companies have challenged its patents with the FDA since September 2023.
The first generic of Mekinist is expected between 2027 and 2028.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before February 2034
The last listed patent runs to February 2034; 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.
Mekinist Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Mekinist’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 7,378,423 | The active ingredient; the product’s formulation | November 2027 with the pediatric extension | Active |
| 8,703,781 | The active ingredient; the product’s formulation; a way of using it (U-2305, U-2302, U-2037, U-1712, U-2020, U-3564) | April 2031 with the pediatric extension | Active |
| 8,952,018 | A way of using it (U-2020) | April 2031 with the pediatric extension | Active |
| 8,580,304 | The product’s formulation | July 2032 with the pediatric extension | Active |
| 9,155,706 | The product’s formulation | July 2032 with the pediatric extension | Active |
| 9,271,941 | The product’s formulation | July 2032 with the pediatric extension | Active |
| 9,399,021 | The product’s formulation | July 2032 with the pediatric extension | Active |
| 10,869,869 | A way of using it (U-3184) | February 2034 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 217513, 204114. Patent numbers open the patent on Google Patents.
Patent Challenges to Mekinist
The first patent challenge to Mekinist reached the FDA in September 2023, from one company on that first day. The FDA’s list has 2 entries for Mekinist, by form and strength. The FDA approved a first challenger’s generic in August 2024, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Mekinist’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 | |||||
| Tablets, 0.5 mg and 2 mg | September 2023 | 1 company | First challenger eligible decided August 2024 | August 2024 | Not yet | January 2032 |
| Tablets, 1 mg | August 2026 | 1 company | No decision yet | Not yet | Not yet | January 2032 |
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 Trametinib Dimethyl Sulfoxide
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
3 companies have applied to the FDA to make generic trametinib dimethyl sulfoxide.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for these yet, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Mekinist’s patents with the FDA since September 2023: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic trametinib dimethyl sulfoxide. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic trametinib dimethyl sulfoxide for sale with the FDA.
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Hikma Pharmaceuticals International Ltd discontinued | August 2024 | EQ 0.5MG, EQ 2MG | – |
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).
Mekinist 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 Mekinist, 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 Mekinist
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 Mekinist, before manufacturer rebates.
- $81.4M
- January to March 2026, the latest CMS has posted
For 2,248 people, about $15,715 per prescription fill - $302.2M
- 2025, the whole year
For 3,588 people, about $15,077 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $81,402,999 | 2,248 | $15,714.86 |
| 2025 | $302,152,650 | 3,588 | $15,076.73 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Mekinist only, so no generic is counted in it. What CMS says it is used for: Trametinib 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
4,772 prescriptions in the four quarters to Q1 2026, $57.1M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 867 | $12,315,477 |
| Q4 2025 | 1,315 | $14,834,226 |
| Q3 2025 | 1,321 | $15,125,342 |
| Q2 2025 | 1,269 | $14,864,164 |
| Q1 2025 | 1,263 | $15,047,053 |
Source: CMS Medicaid State Drug Utilization Data, over Mekinist’s own package codes.
Mekinist Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 0.5MG | Tablet | Oral | May 2013 | Prescription reference product |
| EQ 2MG | Tablet | Oral | May 2013 | Prescription reference product |
| EQ 0.05MG BASE/ML | Solution | Oral | March 2023 | Prescription reference product |
| EQ 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Tablet | Oral | May 2013 | Discontinued reference product |
Source: FDA Orange Book, Novartis Pharmaceuticals Corp. Listed for sale today by Novartis Pharmaceuticals Corporation (FDA NDC Directory).
Mekinist NDC Codes and Packages
Each Mekinist 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 |
|---|---|---|---|
| 00078-0666-15 | 0.5 mg tablet, film coated | bottle of 30 tablets | Novartis Pharmaceuticals Corporation |
| 00078-0668-15 | 2 mg tablet, film coated | bottle of 30 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1161-47 | TRAMETINIB DIMETHYL SULFOXIDE .05 mg/mL powder, for solution | bottle of 90 mL | Novartis Pharmaceuticals Corporation |
| 00078-1161-47 | TRAMETINIB DIMETHYL SULFOXIDE .05 mg/mL powder, for solution | bottle of 90 mL | Novartis Pharmaceuticals Corporation |
| 00078-1105-15 | TRAMETINIB DIMETHYL SULFOXIDE .5 mg/1 tablet, film coated | bottle of 30 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1105-15 | TRAMETINIB DIMETHYL SULFOXIDE .5 mg/1 tablet, film coated | bottle of 30 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1112-15 | TRAMETINIB DIMETHYL SULFOXIDE 2 mg/1 tablet, film coated | bottle of 30 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1112-15 | TRAMETINIB DIMETHYL SULFOXIDE 2 mg/1 tablet, film coated | bottle of 30 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1112-94 | TRAMETINIB DIMETHYL SULFOXIDE 2 mg/1 tablet, film coated | bottle of 14 tablets | Novartis Pharmaceuticals Corporation |
| 00078-1112-94 | TRAMETINIB DIMETHYL SULFOXIDE 2 mg/1 tablet, film coated | bottle of 14 tablets | Novartis Pharmaceuticals Corporation |
Source: the FDA NDC Directory, current listings only. Only packages sold under Mekinist’s own FDA approval (NDA 217513, NDA 204114) are listed, never a generic. Some codes belong to companies that repackage Mekinist: it is the same medicine in a different package.
What a Generic Mekinist Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Mekinist 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 Mekinist”. 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 Mekinist
Is there a generic for Mekinist right now?
No. As of October 9, 2026 no generic trametinib dimethyl sulfoxide is listed for sale in the FDA NDC Directory. 1 generic version is FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Mekinist go generic?
2027 to 2028 is the expected window, and that is probable but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to February 2034; a court ruling or a settlement can bring a generic sooner.
Will generic trametinib dimethyl sulfoxide be the same as Mekinist?
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. 3 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 44% less once two companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Mekinist?
Not yet. The FDA Orange Book lists no approved generic version of Mekinist that is still marketed.
When does the Mekinist patent expire?
The FDA Orange Book lists 8 patents for Mekinist; the last runs to February 2034, counting a six-month pediatric extension. 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 window on this page (2027 to 2028) weighs all of that.
Has anyone challenged the Mekinist patents?
Yes. The first patent challenge to Mekinist reached the FDA in September 2023, from one company on that first day. The FDA approved a first challenger’s generic in August 2024, and the list records no sale by a first challenger 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 2027 to 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
- Stiolto RespimatOlodaterol and TiotropiumOctober 2030
- Jornay PMMethylphenidate HydrochlorideMarch 2032
- WainuaEplontersen SodiumNovember 2036
- OpfoldaMiglustatAugust 2037
- EmpaveliPegcetacoplanDecember 2038
- AttrubyAcoramidis HydrochlorideMarch 2039
About Mekinist
- Generic name trametinib dimethyl sulfoxide
- 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 September 2023 (FDA)
- More drugs Brand-name drugs starting with M
- Have a question? A pharmacist answers, free. Ask about Mekinist
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.