Gavreto Generic: When Will Generic Pralsetinib 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
Gavreto Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? April 2039 About 12.5 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? April 2043 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 pralsetinib is expected to be available in April 2039, about 12.5 years away. None is for sale yet.
Why April 2039?
It is when Gavreto’s patents 11,273,160, 11,872,192 and 11,963,958 end. They cover 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 Gavreto’s last patent runs to April 2043, how can a generic come sooner?
The 2 patents that run past the expected month, to April 2043 (12,448,366 and 12,692,251), cover 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 Gavreto 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.
Gavreto 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
- $50M a yearSmaller seller
- FDA approved 2020 September 2020 FDA Orange Book
- Patents listed 8 last runs to April 2043 A generic is expected sooner, in April 2039. See why FDA Orange Book
- Medicare Part D spent $25M in 2025, for 245 people CMS Part D Spending by Drug
Gavreto’s Road to a Generic
Gavreto has had the market to itself since the FDA approved it in September 2020 (Rigel Pharmaceuticals Inc). Its FDA protection (orphan drug) runs to December 2027. Its 8 listed patents run to April 2043.
The first generic of Gavreto is expected in April 2039.
Why that month: patents 11,273,160, 11,872,192 and 11,963,958, on a way of using it, end then. That is about 4 years before the last listed patent runs out, in April 2043.
Why a Generic Can Come Before April 2043
The last listed patent runs to April 2043; 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.
Gavreto Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Gavreto’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 11,273,160, 11,872,192 and 11,963,958, which end in April 2039, the month the first generic is expected. Why the later ones may not hold it back
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,030,005 | The active ingredient; the product’s formulation; a way of using it (U-2952, U-3002) | November 2036 | Active |
| 12,655,128 | The active ingredient; the product’s formulation | November 2036 | Active |
| 11,273,160 Sets the expected month of generic availability | A way of using it (U-2952) | April 2039 | Active |
| 11,872,192 Sets the expected month of generic availability | A way of using it (U-2952) | April 2039 | Active |
| 11,963,958 Sets the expected month of generic availability | A way of using it (U-2828) | April 2039 | Active |
| 12,539,303 | A way of using it (U-2828) | April 2039 | Active |
| 12,448,366 | The active ingredient | July 2042 | Active |
| 12,692,251 | The product’s formulation | April 2043 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| Orphan drug ODE-318 | Seven years of protection for a use in a rare disease. | September 2027 | Active |
| Orphan drug ODE-340 | Seven years of protection for a use in a rare disease. | December 2027 | Active |
| Orphan drug ODE-341 | Seven years of protection for a use in a rare disease. | December 2027 | Active |
Source: FDA Orange Book, application 213721. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Pralsetinib
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 Gavreto yet.
Approved by the FDA
Not yet. The FDA has not approved a generic pralsetinib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic pralsetinib 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).
Gavreto 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 Gavreto, 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 Gavreto
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 Gavreto, before manufacturer rebates.
- $6.3M
- January to March 2026, the latest CMS has posted
For 173 people, about $15,088 per prescription fill - $25M
- 2025, the whole year
For 245 people, about $15,288 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $6,321,737 | 173 | $15,087.68 |
| 2025 | $24,964,722 | 245 | $15,287.64 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Gavreto 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 (lung and thyroid). Pralsetinib belongs to a class of drugs known as kinase inhibitors.
Gavreto Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG | Capsule | Oral | September 2020 | Prescription reference product |
Source: FDA Orange Book, Rigel Pharmaceuticals Inc. Listed for sale today by Genentech, Inc. and Rigel Pharmaceuticals, Inc. (FDA NDC Directory).
Gavreto NDC Codes and Packages
Each Gavreto 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 |
|---|---|---|---|
| 50242-0210-12 | 100 mg capsule | bottle of 120 capsules | Genentech, Inc. |
| 50242-0210-60 | 100 mg capsule | bottle of 60 capsules | Genentech, Inc. |
| 50242-0210-60 | 100 mg capsule | bottle of 60 capsules | Genentech, Inc. |
| 50242-0210-83 | 100 mg capsule | bottle of 60 capsules | Genentech, Inc. |
| 50242-0210-83 | 100 mg capsule | bottle of 60 capsules | Genentech, Inc. |
| 50242-0210-90 | 100 mg capsule | bottle of 90 capsules | Genentech, Inc. |
| 50242-0210-90 | 100 mg capsule | bottle of 90 capsules | Genentech, Inc. |
| 71332-0006-12 | PRALSETINIB 100 mg/1 capsule | bottle of 120 capsules | Rigel Pharmaceuticals, Inc. |
| 71332-0006-60 | PRALSETINIB 100 mg/1 capsule | bottle of 60 capsules | Rigel Pharmaceuticals, Inc. |
| 71332-0006-90 | PRALSETINIB 100 mg/1 capsule | bottle of 90 capsules | Rigel Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Gavreto’s own FDA approval (NDA 213721) are listed, never a generic. Some codes belong to companies that repackage Gavreto: it is the same medicine in a different package.
What a Generic Gavreto Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Gavreto 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 Gavreto”. 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 Gavreto
Is there a generic for Gavreto right now?
No. As of October 9, 2026 no generic pralsetinib is listed for sale in the FDA NDC Directory.
When will Gavreto go generic?
April 2039 is the expected month, and that is probable but not certain. It is when Gavreto’s patents 11,273,160, 11,872,192 and 11,963,958 end. They cover 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 April 2043; a court ruling or a settlement can bring a generic sooner.
Will generic pralsetinib be the same as Gavreto?
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 Gavreto?
Not yet. The FDA Orange Book lists no approved generic version of Gavreto.
When does the Gavreto patent expire?
The FDA Orange Book lists 8 patents for Gavreto; the last runs to April 2043. The one behind the expected month is patents 11,273,160, 11,872,192 and 11,963,958, which end in April 2039. 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 (April 2039) weighs all of that.
Changes to This Projection
- First generic expected April 2039 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
- Edurant PedRilpivirine HydrochlorideSeptember 2027
- Sodium ThiosulfateSodium ThiosulfateDuring 2028
- Jakafi XRRuxolitinib Phosphate2030 to 2031
- VoseviSofosbuvir, Velpatasvir, and Voxilaprevir2035 to 2036
- OmlontiOmidenepag IsopropylJanuary 2035
- AqneursaLevacetylleucineApril 2037
About Gavreto
- Generic name pralsetinib
- How it is taken By mouth
- Company Rigel Pharmaceuticals Inc
- More drugs Brand-name drugs starting with G
- Have a question? A pharmacist answers, free. Ask about Gavreto
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, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.