Rasonque Generic: When Will Generic Daraxonrasib Be Available?

Dr. Brian Staiger, PharmD, BCPS

This page is aggregated from FDA records, court filings and company announcements. Coded and designed by

Updated October 9, 2026 How we build our data

Rasonque Generic at a Glance

Four quick answers from FDA records and our estimate.

  1. When is the first generic expected? During 2041 Sometime that year Why then?
  2. Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
  3. When does the brand’s protection end? None listed No patent or exclusivity on file
  4. Can you buy a generic today? Not yet No company lists one for sale

Explains

PharmD, BCPS · Clinical pharmacist Updated

Generic daraxonrasib is expected to be available sometime in 2041. None is for sale yet.

Why 2041?

The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it toss-up: still unsettled. Just as likely to slip as to hold.

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 Rasonque 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.

Rasonque by the Numbers

Reason
Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
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
Sales not reported
  • FDA approved 2026 August 2026 FDA Orange Book
  • Patents listed 0 none listed FDA Orange Book

Rasonque’s Road to a Generic

Rasonque has had the market to itself since the FDA approved it in August 2026 (Revolution Medicines Inc).

The first generic of Rasonque is expected sometime in 2041.

Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.

Brand alone on the market Since FDA approval, August 2026
Brand alone on the market First generic expected Swipe the chart sideways to see every year.

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.

Who Is Lined Up to Make Generic Daraxonrasib

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.

1

Applied to the FDA

No company is recorded as having applied to the FDA to make a generic Rasonque yet.

2

Approved by the FDA

Not yet. The FDA has not approved a generic daraxonrasib. Final approval often comes close to the day a generic can be sold.

3

For Sale in Pharmacies

Not yet. No company lists a generic daraxonrasib 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).

Rasonque 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 Rasonque, 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.

Rasonque Strengths and Forms

StrengthFormHow it is takenApprovedStatus
100MGTabletOralAugust 2026Prescription reference product
150MGTabletOralAugust 2026Prescription reference product

Source: FDA Orange Book, Revolution Medicines Inc. Listed for sale today by Revolution Medicines, Inc. and Shanghai SynTheAll Pharmaceutical Co., Ltd. (FDA NDC Directory).

Rasonque NDC Codes and Packages

Each Rasonque 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.

Rasonque packages (6)
NDCProductPackageCompany
24538-0440-01DARAXONRASIB 100 mg/1 tablet, film coatedbottle of 30 tabletsShanghai SynTheAll Pharmaceutical Co., Ltd.
85219-0101-01DARAXONRASIB 100 mg/1 tablet, film coatedbottle of 30 tabletsRevolution Medicines, Inc.
24538-0430-01DARAXONRASIB 100 mg/100mg tablet, film coatedbottle of 30 mgShanghai SynTheAll Pharmaceutical Co., Ltd.
24538-0441-01DARAXONRASIB 150 mg/1 tablet, film coatedbottle of 30 tabletsShanghai SynTheAll Pharmaceutical Co., Ltd.
85219-0104-01DARAXONRASIB 150 mg/1 tablet, film coatedbottle of 30 tabletsRevolution Medicines, Inc.
24538-0435-01DARAXONRASIB 150 mg/150mg tablet, film coatedbottle of 30 mgShanghai SynTheAll Pharmaceutical Co., Ltd.

Source: the FDA NDC Directory, current listings only. Only packages sold under Rasonque’s own FDA approval (NDA 220910) are listed, never a generic. Some codes belong to companies that repackage Rasonque: it is the same medicine in a different package.

What a Generic Rasonque Means for You

Nothing Changes Until It Is in Pharmacies

Until a generic is actually for sale, keep filling Rasonque 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 Rasonque”. 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 Rasonque

Is there a generic for Rasonque right now?

No. As of October 9, 2026 no generic daraxonrasib is listed for sale in the FDA NDC Directory.

When will Rasonque go generic?

Sometime in 2041 is the expected window, and that is toss-up but not certain. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.

Will generic daraxonrasib be the same as Rasonque?

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 Rasonque?

Not yet. The FDA Orange Book lists no approved generic version of Rasonque.

When does the Rasonque patent expire?

No patents are listed for Rasonque in the FDA Orange Book. Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.

Changes to This Projection

  • First generic expected Sometime in 2041 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

All upcoming generics

About Rasonque

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, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.