Cotellic Generic: When Will Generic Cobimetinib 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
Cotellic Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2030 About 3.5 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 2036 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 cobimetinib is expected to be available in May 2030, about 3.5 years away. None is for sale yet.
Why May 2030?
It is when Cotellic’s patent 7,803,839 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 Cotellic’s last patent runs to December 2036, how can a generic come sooner?
The 4 patents that run past the expected month, to December 2036 (11,087,354, 10,478,400, 10,590,102 and 11,254,649), cover a way of using it, 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 Cotellic 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.
Cotellic 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
- $29M a yearSmaller seller
- FDA approved 2015 November 2015 FDA Orange Book
- Patents listed 7 last runs to December 2036 A generic is expected sooner, in May 2030. See why FDA Orange Book
- Medicare Part D spent $11.3M in 2025, for 337 people CMS Part D Spending by Drug
- Medicaid prescriptions 168 in the last four reported quarters, $988.9K CMS Medicaid drug utilization, to Q4 2025
Cotellic’s Road to a Generic
Cotellic has had the market to itself since the FDA approved it in November 2015 (Genentech Inc). Its FDA protection (orphan drug) runs to October 2029. Its 7 listed patents run to December 2036 (1 already expired).
The first generic of Cotellic is expected in May 2030.
Why that month: patent 7,803,839, on the active ingredient and the product’s formulation, ends then. That is about 6.5 years before the last listed patent runs out, in December 2036.
Why a Generic Can Come Before December 2036
The last listed patent runs to December 2036; 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.
Cotellic Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Cotellic’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 7,803,839, which ends in May 2030, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 11,597,699 | A way of using it (U-3554) | October 2026 | Expired |
| 8,362,002 | A way of using it (U-1776) | April 2027 with the pediatric extension | Active |
| 7,803,839 Sets the expected month of generic availability | The active ingredient; the product’s formulation | May 2030 with the pediatric extension | Active |
| 11,087,354 | A way of using it (U-1776) | December 2034 with the pediatric extension | Active |
| 10,478,400 | The active ingredient; the product’s formulation; a way of using it (U-1776) | December 2036 with the pediatric extension | Active |
| 10,590,102 | The active ingredient; the product’s formulation; a way of using it (U-1776) | December 2036 with the pediatric extension | Active |
| 11,254,649 | The active ingredient; the product’s formulation; a way of using it (U-1776) | December 2036 with the pediatric extension | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New clinical information M-278 | Three years of protection for a change backed by new clinical studies. | July 2025 | Ended |
| Pediatric PED | Six more months, earned by studying the medicine in children. | January 2026 | Ended |
| Orphan drug ODE-416 | Seven years of protection for a use in a rare disease. | October 2029 | Active |
Source: FDA Orange Book, application 206192. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Cobimetinib
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 Cotellic yet.
Approved by the FDA
Not yet. The FDA has not approved a generic cobimetinib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic cobimetinib 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).
Cotellic 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 Cotellic, 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 Cotellic
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 Cotellic, before manufacturer rebates.
- $2.8M
- January to March 2026, the latest CMS has posted
For 233 people, about $4,964 per prescription fill - $11.3M
- 2025, the whole year
For 337 people, about $5,136 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $2,804,811 | 233 | $4,964.27 |
| 2025 | $11,264,164 | 337 | $5,136.42 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Cotellic only, so no generic is counted in it. What CMS says it is used for: Cobimetinib is used to treat a type of skin cancer (melanoma). It is also used to treat a certain group of blood cancers (histiocytic neoplasms).
Medicaid Prescriptions by Quarter
168 prescriptions in the four quarters to Q4 2025, $988.9K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q4 2025 | 52 | $309,899 |
| Q3 2025 | 47 | $304,510 |
| Q2 2025 | 33 | $183,321 |
| Q1 2025 | 36 | $191,171 |
Source: CMS Medicaid State Drug Utilization Data, over Cotellic’s own package codes.
Cotellic Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 20MG BASE | Tablet | Oral | November 2015 | Prescription reference product |
Source: FDA Orange Book, Genentech Inc. Listed for sale today by Genentech, Inc. (FDA NDC Directory).
Cotellic NDC Codes and Packages
Each Cotellic 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 |
|---|---|---|---|
| 50242-0717-01 | COBIMETINIB FUMARATE 20 mg/1 tablet, film coated | bottle of 63 tablets | Genentech, Inc. |
| 50242-0717-01 | COBIMETINIB FUMARATE 20 mg/1 tablet, film coated | bottle of 63 tablets | Genentech, Inc. |
| 50242-0717-86 | COBIMETINIB FUMARATE 20 mg/1 tablet, film coated | bottle of 63 tablets | Genentech, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Cotellic’s own FDA approval (NDA 206192) are listed, never a generic. Some codes belong to companies that repackage Cotellic: it is the same medicine in a different package.
What a Generic Cotellic Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Cotellic 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 Cotellic”. 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 Cotellic
Is there a generic for Cotellic right now?
No. As of October 9, 2026 no generic cobimetinib is listed for sale in the FDA NDC Directory.
When will Cotellic go generic?
May 2030 is the expected month, and that is toss-up but not certain. It is when Cotellic’s patent 7,803,839 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 December 2036; a court ruling or a settlement can bring a generic sooner.
Will generic cobimetinib be the same as Cotellic?
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 Cotellic?
Not yet. The FDA Orange Book lists no approved generic version of Cotellic.
When does the Cotellic patent expire?
The FDA Orange Book lists 7 patents for Cotellic; the last runs to December 2036, counting a six-month pediatric extension. The one behind the expected month is patent 7,803,839, which ends in May 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 (May 2030) weighs all of that.
Changes to This Projection
- First generic expected May 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
- XalkoriCrizotinibOctober 2029
- KloxxadoNaloxone Hydrochloride2033 to 2034
- SyfovrePegcetacoplan2035 to 2036
- AyvakitAvapritinib2035 to 2036
- Osmolex ERAmantadine HydrochlorideFebruary 2038
- EraxisAnidulafunginTBD no date yet
About Cotellic
- Generic name cobimetinib
- How it is taken By mouth
- Company Genentech 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 C
- Have a question? A pharmacist answers, free. Ask about Cotellic
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.