Lumakras Generic: When Will Generic Sotorasib 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
Lumakras Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? August 2040 About 14 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? September 2040 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 sotorasib is expected to be available in August 2040, about 14 years away. None is for sale yet.
Why August 2040?
It is when Lumakras’s patent 11,426,404 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 Lumakras’s last patent runs to September 2040, how can a generic come sooner?
The patent that runs to September 2040 (11,426,404) 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 Lumakras 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.
Lumakras 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
- $262M a yearBig seller
- FDA approved 2021 May 2021 FDA Orange Book
- Patents listed 6 last runs to September 2040 A generic is expected sooner, in August 2040. See why FDA Orange Book
- Medicare Part D spent $202.3M in 2025, for 2,003 people CMS Part D Spending by Drug
- Medicaid prescriptions 264 in the last four reported quarters, $4.9M CMS Medicaid drug utilization, to Q1 2026
Lumakras’s Road to a Generic
Lumakras has had the market to itself since the FDA approved it in May 2021 (Amgen Inc). Its FDA protection (orphan drug) runs to January 2032. Its 6 listed patents run to September 2040.
The first generic of Lumakras is expected in August 2040.
Why that month: patent 11,426,404, on a way of using it, ends then. That is a few months before the last listed patent runs out, in September 2040.
Why a Generic Can Come Before September 2040
The last listed patent runs to September 2040, 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.
Lumakras Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Lumakras’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 11,426,404, which ends in September 2040. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,519,146 | The active ingredient; the product’s formulation | May 2038 | Active |
| 12,280,056 | A way of using it (U-4107) | November 2039 | Active |
| 11,236,091 | The active ingredient; the product’s formulation; a way of using it (U-3306, U-4107) | May 2040 | Active |
| 11,827,635 | The active ingredient; the product’s formulation; a way of using it (U-4107, U-3306) | May 2040 | Active |
| 12,398,133 | The active ingredient; the product’s formulation; a way of using it (U-3306, U-4107) | May 2040 | Active |
| 11,426,404 Sets the expected month of generic availability | A way of using it (U-3306, U-4107) | September 2040 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | May 2026 | Ended |
| New use I-962 | Three years of protection for a newly approved use (indication). | January 2028 | Active |
| FDA exclusivity ODE* | A period of protection the FDA granted (code ODE*). | May 2028 | Active |
| Orphan drug ODE-352 | Seven years of protection for a use in a rare disease. | May 2028 | Active |
| Orphan drug ODE-507 | Seven years of protection for a use in a rare disease. | January 2032 | Active |
Source: FDA Orange Book, application 214665. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Sotorasib
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 Lumakras yet.
Approved by the FDA
Not yet. The FDA has not approved a generic sotorasib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic sotorasib 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).
Lumakras 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 Lumakras, 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 Lumakras
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 Lumakras, before manufacturer rebates.
- $56.6M
- January to March 2026, the latest CMS has posted
For 1,330 people, about $18,161 per prescription fill - $202.3M
- 2025, the whole year
For 2,003 people, about $17,959 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $56,645,428 | 1,330 | $18,161.41 |
| 2025 | $202,313,178 | 2,003 | $17,959.45 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Lumakras only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat certain types of cancer (such as lung, colorectal). It works by slowing or stopping the growth of cancer cells.
Medicaid Prescriptions by Quarter
264 prescriptions in the four quarters to Q1 2026, $4.9M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 71 | $1,371,212 |
| Q4 2025 | 84 | $1,489,157 |
| Q3 2025 | 42 | $864,972 |
| Q2 2025 | 67 | $1,204,068 |
| Q1 2025 | 87 | $1,644,051 |
Source: CMS Medicaid State Drug Utilization Data, over Lumakras’s own package codes.
Lumakras Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 120MG | Tablet | Oral | May 2021 | Prescription reference product |
| 320MG | Tablet | Oral | January 2023 | Prescription reference product |
| 240MG | Tablet | Oral | June 2024 | Prescription reference product |
Source: FDA Orange Book, Amgen Inc. Listed for sale today by Amgen Inc (FDA NDC Directory).
Lumakras NDC Codes and Packages
Each Lumakras 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 |
|---|---|---|---|
| 55513-0488-02 | SOTORASIB 120 mg/1 tablet, coated | carton of 2 bottles of 120 tablets | Amgen Inc |
| 55513-0488-02 | SOTORASIB 120 mg/1 tablet, coated | carton of 2 bottles of 120 tablets | Amgen Inc |
| 55513-0488-24 | SOTORASIB 120 mg/1 tablet, coated | bottle of 240 tablets | Amgen Inc |
| 55513-0488-24 | SOTORASIB 120 mg/1 tablet, coated | bottle of 240 tablets | Amgen Inc |
| 55513-0488-96 | SOTORASIB 120 mg/1 tablet, coated | bottle of 120 tablets | Amgen Inc |
| 55513-0488-96 | SOTORASIB 120 mg/1 tablet, coated | bottle of 120 tablets | Amgen Inc |
| 55513-0512-60 | SOTORASIB 240 mg/1 tablet, coated | bottle of 120 tablets | Amgen Inc |
| 55513-0504-50 | SOTORASIB 320 mg/1 tablet, coated | bottle of 90 tablets | Amgen Inc |
| 55513-0504-50 | SOTORASIB 320 mg/1 tablet, coated | bottle of 90 tablets | Amgen Inc |
Source: the FDA NDC Directory, current listings only. Only packages sold under Lumakras’s own FDA approval (NDA 214665) are listed, never a generic. Some codes belong to companies that repackage Lumakras: it is the same medicine in a different package.
What a Generic Lumakras Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Lumakras 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 Lumakras”. 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 Lumakras
Is there a generic for Lumakras right now?
No. As of October 9, 2026 no generic sotorasib is listed for sale in the FDA NDC Directory.
When will Lumakras go generic?
August 2040 is the expected month, and that is probable but not certain. It is when Lumakras’s patent 11,426,404 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 September 2040, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic sotorasib be the same as Lumakras?
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 Lumakras?
Not yet. The FDA Orange Book lists no approved generic version of Lumakras.
When does the Lumakras patent expire?
The FDA Orange Book lists 6 patents for Lumakras; the last runs to September 2040. The one behind the expected month is patent 11,426,404, which ends in September 2040. 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 (August 2040) weighs all of that.
Changes to This Projection
- First generic expected August 2040 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
- IyuzehLatanoprostJuly 2031
- Voquezna Dual PakAmoxicillin and Vonoprazan Fumarate2033 to 2034
- SkyclarysOmaveloxoloneFebruary 2037
- DylojectDiclofenac SodiumTBD no date yet
- OleptroTrazodone HydrochlorideTBD no date yet
About Lumakras
- Generic name sotorasib
- How it is taken By mouth
- Company Amgen Inc
- More drugs Brand-name drugs starting with L
- Have a question? A pharmacist answers, free. Ask about Lumakras
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.