Retevmo Generic: When Will Generic Selpercatinib 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
Retevmo 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 2039 6 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic selpercatinib is expected to be available in April 2039, about 12.5 years away, first for Retevmo tablet. None is for sale yet. Each product has its own month below.
Why April 2039?
It is when Retevmo’s patent 12,138,250 ends. That patent covers a way of using it, and once it ends, generics can 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.
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 Retevmo 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
- tabletApril 2039Toss-up · patent expires
- capsulea date that is not known yetNot rated · not yet clear
Our month is only an estimate based on available information, so we never name a day.
Retevmo 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
- $342M a yearBig seller
- FDA approved 2020 May 2020 FDA Orange Book
- Patents listed 6 last runs to April 2039 FDA Orange Book
- Medicare Part D spent $120M in 2025, for 875 people CMS Part D Spending by Drug
- Medicaid prescriptions 206 in the last four reported quarters, $4.2M CMS Medicaid drug utilization, to Q1 2026
Retevmo’s Road to a Generic
Retevmo has had the market to itself since the FDA approved it in May 2020 (Eli Lilly And Co). Its FDA protection (pediatric) runs to November 2031. Its 6 listed patents run to April 2039. Generic companies have challenged its patents with the FDA since May 2024.
The first generic of Retevmo is expected in April 2039.
Why that month: patent 12,138,250, on a way of using it, ends then.
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.
Retevmo Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Retevmo’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 12,138,250, which ends in April 2039, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,112,942 | The active ingredient; the product’s formulation | April 2038 with the pediatric extension | Active |
| 10,137,124 | A way of using it (U-3450, U-3949, U-3950, U-3951) | April 2038 with the pediatric extension | Active |
| 10,172,851 | A way of using it (U-3450, U-3949, U-3950, U-3951) | April 2038 with the pediatric extension | Active |
| 10,584,124 | The active ingredient; a way of using it (U-3450, U-3949, U-3950, U-3951) | April 2039 with the pediatric extension | Active |
| 10,786,489 | The product’s formulation; a way of using it (U-3450, U-3949, U-3951, U-3950) | April 2039 with the pediatric extension | Active |
| 12,138,250 Sets the expected month of generic availability | A way of using it (U-3949, U-3951, U-3950, U-3450) | April 2039 with the pediatric extension | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| Orphan drug ODE-301 | Seven years of protection for a use in a rare disease. | May 2027 | Active |
| Orphan drug ODE-302 | Seven years of protection for a use in a rare disease. | May 2027 | Active |
| Orphan drug ODE-303 | Seven years of protection for a use in a rare disease. | May 2027 | Active |
| New patient population NPP | Three years of protection for a newly approved group of patients. | May 2027 | Active |
| New clinical information M-311 | Three years of protection for a change backed by new clinical studies. | September 2027 | Active |
| New clinical information M-312 | Three years of protection for a change backed by new clinical studies. | September 2027 | Active |
| Orphan drug ODE-409 | Seven years of protection for a use in a rare disease. | September 2029 | Active |
| Orphan drug ODE-412 | Seven years of protection for a use in a rare disease. | September 2029 | Active |
| FDA exclusivity ODE* | A period of protection the FDA granted (code ODE*). | May 2031 | Active |
| Orphan drug ODE-484 | Seven years of protection for a use in a rare disease. | May 2031 | Active |
| Orphan drug ODE-485 | Seven years of protection for a use in a rare disease. | May 2031 | Active |
| Orphan drug ODE-487 | Seven years of protection for a use in a rare disease. | May 2031 | Active |
| Pediatric PED | Six more months, earned by studying the medicine in children. | November 2031 | Active |
Source: FDA Orange Book, application 213246, 218160. Patent numbers open the patent on Google Patents.
Patent Challenges to Retevmo
The first patent challenge to Retevmo reached the FDA in May 2024, from one company on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Retevmo’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 | |||||
| Capsules, 40 mg and 80 mg | May 2024 | 1 company | Head start no longer applies decided August 2024 | Not yet | Not yet | October 2037 |
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 Selpercatinib
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 Retevmo yet.
Generic companies have challenged Retevmo’s patents with the FDA since May 2024: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic selpercatinib. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic selpercatinib 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).
Retevmo 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 Retevmo, 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 Retevmo
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 Retevmo, before manufacturer rebates.
- $35.8M
- January to March 2026, the latest CMS has posted
For 734 people, about $18,995 per prescription fill - $120M
- 2025, the whole year
For 875 people, about $18,767 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $35,768,192 | 734 | $18,995.32 |
| 2025 | $119,994,536 | 875 | $18,766.74 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Retevmo 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 cancer, thyroid cancer, medullary thyroid cancer, certain other solid tumors). Selpercatinib belongs to a class of drugs known as kinase inhibitors.
Medicaid Prescriptions by Quarter
206 prescriptions in the four quarters to Q1 2026, $4.2M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 65 | $1,434,638 |
| Q4 2025 | 63 | $1,240,862 |
| Q3 2025 | 44 | $912,915 |
| Q2 2025 | 34 | $601,564 |
| Q1 2025 | 41 | $680,551 |
Source: CMS Medicaid State Drug Utilization Data, over Retevmo’s own package codes.
Retevmo Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 40MG | Capsule | Oral | May 2020 | Prescription reference product |
| 80MG | Capsule | Oral | May 2020 | Prescription reference product |
| 120MG | Tablet | Oral | April 2024 | Prescription reference product |
| 160MG | Tablet | Oral | April 2024 | Prescription reference product |
| 40MG | Tablet | Oral | April 2024 | Prescription reference product |
| 80MG | Tablet | Oral | April 2024 | Prescription reference product |
Source: FDA Orange Book, Eli Lilly And Co. Listed for sale today by Eli Lilly and Company (FDA NDC Directory).
Retevmo NDC Codes and Packages
Each Retevmo 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 |
|---|---|---|---|
| 00002-6120-60 | SELPERCATINIB 120 mg/1 tablet, coated | bottle of 60 tablets | Eli Lilly and Company |
| 00002-5562-60 | SELPERCATINIB 160 mg/1 tablet, coated | bottle of 60 tablets | Eli Lilly and Company |
| 00002-3977-60 | SELPERCATINIB 40 mg/1 capsule | bottle of 60 capsules | Eli Lilly and Company |
| 00002-3977-60 | SELPERCATINIB 40 mg/1 capsule | bottle of 60 capsules | Eli Lilly and Company |
| 00002-5340-60 | SELPERCATINIB 40 mg/1 tablet, coated | bottle of 60 tablets | Eli Lilly and Company |
| 00002-2980-26 | SELPERCATINIB 80 mg/1 capsule | bottle of 120 capsules | Eli Lilly and Company |
| 00002-2980-26 | SELPERCATINIB 80 mg/1 capsule | bottle of 120 capsules | Eli Lilly and Company |
| 00002-2980-60 | SELPERCATINIB 80 mg/1 capsule | bottle of 60 capsules | Eli Lilly and Company |
| 00002-2980-60 | SELPERCATINIB 80 mg/1 capsule | bottle of 60 capsules | Eli Lilly and Company |
| 00002-6082-60 | SELPERCATINIB 80 mg/1 tablet, coated | bottle of 60 tablets | Eli Lilly and Company |
Source: the FDA NDC Directory, current listings only. Only packages sold under Retevmo’s own FDA approval (NDA 213246, NDA 218160) are listed, never a generic. Some codes belong to companies that repackage Retevmo: it is the same medicine in a different package.
What a Generic Retevmo Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Retevmo 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 Retevmo”. 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 Retevmo
Is there a generic for Retevmo right now?
No. As of October 9, 2026 no generic selpercatinib is listed for sale in the FDA NDC Directory.
When will Retevmo go generic?
April 2039 is the expected month, and that is toss-up but not certain. It is when Retevmo’s patent 12,138,250 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic selpercatinib be the same as Retevmo?
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 Retevmo?
Not yet. The FDA Orange Book lists no approved generic version of Retevmo.
When does the Retevmo patent expire?
The FDA Orange Book lists 6 patents for Retevmo; the last runs to April 2039, counting a six-month pediatric extension. The one behind the expected month is patent 12,138,250, which ends 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.
Has anyone challenged the Retevmo patents?
Yes. The first patent challenge to Retevmo reached the FDA in May 2024, from one company on that first day. The FDA has not approved a first challenger’s generic 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 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
- SymdekoIvacaftor and TezacaftorJuly 2031
- Esmolol HydrochlorideEsmolol HydrochlorideMarch 2033
- XdemvyLotilaner2036 to 2037
- BarhemsysAmisulprideFebruary 2038
- KomziftiZiftomenibNovember 2039
- OsmoprepSodium Phosphate, Dibasic, Anhydrous and Sodium Phosphate, Monobasic, MonohydrateTBD no date yet
About Retevmo
- Generic name selpercatinib
- How it is taken By mouth
- Company Eli Lilly And Co
- Patent challenges Since May 2024 (FDA)
- More drugs Brand-name drugs starting with R
- Have a question? A pharmacist answers, free. Ask about Retevmo
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.