Vitrakvi Generic: When Will Generic Larotrectinib 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
Vitrakvi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? May 2037 About 10.5 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? May 2037 20 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic larotrectinib sulfate is expected to be available in May 2037, about 10.5 years away. None is for sale yet.
Why May 2037?
It is when Vitrakvi’s patent 11,337,967 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 probable: more likely than not, but it can still move.
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 Vitrakvi 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
- oral solutionMay 2037Probable · patent expires
- capsuleMay 2037Toss-up · patent expires
Our month is only an estimate based on available information, so we never name a day.
Vitrakvi 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
- Sales not reported
- FDA approved 2018 November 2018 FDA Orange Book
- Patents listed 20 last runs to May 2037 FDA Orange Book
- Medicare Part D spent $55.4M in 2025, for 232 people CMS Part D Spending by Drug
- Medicaid prescriptions 27 in the last four reported quarters, $894.4K CMS Medicaid drug utilization, to Q1 2026
Vitrakvi’s Road to a Generic
Vitrakvi has had the market to itself since the FDA approved it in November 2018 (Bayer Healthcare Pharmaceuticals Inc). Its 20 listed patents run to May 2037. Generic companies have challenged its patents with the FDA since May 2025.
The first generic of Vitrakvi is expected in May 2037.
Why that month: patent 11,337,967, 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.
Vitrakvi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Vitrakvi’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 11,337,967, which ends in May 2037, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,865,698 | A way of using it (U-2469) | October 2029 | Active |
| 9,127,013 | The active ingredient; the product’s formulation | October 2029 | Active |
| 9,447,104 | A way of using it (U-2470) | October 2029 | Active |
| 9,676,783 | A way of using it (U-2469) | October 2029 | Active |
| 10,005,783 | A way of using it (U-2472) | October 2029 | Active |
| 10,047,097 | A way of using it (U-2474) | October 2029 | Active |
| 10,774,085 | A way of using it (U-2470) | October 2029 | Active |
| 8,513,263 | The active ingredient; the product’s formulation | December 2029 | Active |
| 9,782,414 | A way of using it (U-2475, U-2471) | November 2035 | Active |
| 10,172,861 | The active ingredient; the product’s formulation | November 2035 | Active |
| 10,285,993 | A way of using it (U-2470) | November 2035 | Active |
| 10,813,936 | A way of using it (U-2987) | November 2035 | Active |
| 10,799,505 | The active ingredient; the product’s formulation | August 2036 | Active |
| 10,045,991 | A way of using it (U-2473) | April 2037 | Active |
| 10,137,127 | The product’s formulation | April 2037 | Active |
| 10,668,072 | The product’s formulation | April 2037 | Active |
| 11,191,766 | A way of using it (U-2471) | April 2037 | Active |
| 11,484,535 | A way of using it (U-2470) | April 2037 | Active |
| 11,337,967 Sets the expected month of generic availability | A way of using it (U-4123) | May 2037 | Active |
| 11,974,998 | A way of using it (U-4124) | May 2037 | Active |
Source: FDA Orange Book, application 210861, 211710. Patent numbers open the patent on Google Patents.
Patent Challenges to Vitrakvi
The first patent challenge to Vitrakvi reached the FDA in May 2025, 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 Vitrakvi’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, 25 mg and 100 mg | May 2025 | 1 company | No decision yet | Not yet | Not yet | May 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 Larotrectinib Sulfate
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 Vitrakvi yet.
Generic companies have challenged Vitrakvi’s patents with the FDA since May 2025: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic larotrectinib sulfate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic larotrectinib sulfate 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).
Vitrakvi 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 Vitrakvi, 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 Vitrakvi
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 Vitrakvi, before manufacturer rebates.
- $15.3M
- January to March 2026, the latest CMS has posted
For 157 people, about $39,993 per prescription fill - $55.4M
- 2025, the whole year
For 232 people, about $38,028 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $15,277,511 | 157 | $39,993.48 |
| 2025 | $55,368,158 | 232 | $38,027.58 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Vitrakvi only, so no generic is counted in it. What CMS says it is used for: Larotrectinib is used to treat cancer. It works by slowing or stopping the growth of cancer cells.
Medicaid Prescriptions by Quarter
27 prescriptions in the four quarters to Q1 2026, $894.4K paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 0 | $0 |
| Q4 2025 | 16 | $461,855 |
| Q3 2025 | 11 | $432,567 |
| Q2 2025 | 0 | $0 |
| Q1 2025 | 15 | $644,208 |
Source: CMS Medicaid State Drug Utilization Data, over Vitrakvi’s own package codes.
Vitrakvi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 100MG BASE | Capsule | Oral | November 2018 | Prescription reference product |
| EQ 20MG BASE/ML | Solution | Oral | November 2018 | Prescription reference product |
| EQ 25MG BASE | Capsule | Oral | November 2018 | Prescription reference product |
Source: FDA Orange Book, Bayer Healthcare Pharmaceuticals Inc. Listed for sale today by Bayer HealthCare Pharmaceuticals Inc. and Loxo Oncology, Inc. (FDA NDC Directory).
Vitrakvi NDC Codes and Packages
Each Vitrakvi 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 |
|---|---|---|---|
| 50419-0391-01 | LAROTRECTINIB 100 mg/1 capsule | bottle of 60 capsules | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0391-01 | LAROTRECTINIB 100 mg/1 capsule | bottle of 60 capsules | Bayer HealthCare Pharmaceuticals Inc. |
| 71777-0391-01 | LAROTRECTINIB 100 mg/1 capsule | bottle of 60 capsules | Loxo Oncology, Inc. |
| 71777-0391-01 | LAROTRECTINIB 100 mg/1 capsule | bottle of 60 capsules | Loxo Oncology, Inc. |
| 71777-0392-01 | LAROTRECTINIB 20 mg/mL solution | bottle of 100 mL | Loxo Oncology, Inc. |
| 71777-0392-01 | LAROTRECTINIB 20 mg/mL solution | bottle of 100 mL | Loxo Oncology, Inc. |
| 50419-0392-01 | LAROTRECTINIB 20 mg/mL solution, concentrate | bottle of 100 mL | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0392-01 | LAROTRECTINIB 20 mg/mL solution, concentrate | bottle of 100 mL | Bayer HealthCare Pharmaceuticals Inc. |
Show the other 6 Vitrakvi packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 50419-0393-03 | LAROTRECTINIB 20 mg/mL solution, concentrate | carton of 2 bottles of 50 mL | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0393-03 | LAROTRECTINIB 20 mg/mL solution, concentrate | carton of 2 bottles of 50 mL | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0390-01 | LAROTRECTINIB 25 mg/1 capsule | bottle of 60 capsules | Bayer HealthCare Pharmaceuticals Inc. |
| 50419-0390-01 | LAROTRECTINIB 25 mg/1 capsule | bottle of 60 capsules | Bayer HealthCare Pharmaceuticals Inc. |
| 71777-0390-01 | LAROTRECTINIB 25 mg/1 capsule | bottle of 60 capsules | Loxo Oncology, Inc. |
| 71777-0390-01 | LAROTRECTINIB 25 mg/1 capsule | bottle of 60 capsules | Loxo Oncology, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Vitrakvi’s own FDA approval (NDA 210861, NDA 211710) are listed, never a generic. Some codes belong to companies that repackage Vitrakvi: it is the same medicine in a different package.
What a Generic Vitrakvi Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Vitrakvi 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 Vitrakvi”. 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 Vitrakvi
Is there a generic for Vitrakvi right now?
No. As of October 9, 2026 no generic larotrectinib sulfate is listed for sale in the FDA NDC Directory.
When will Vitrakvi go generic?
May 2037 is the expected month, and that is probable but not certain. It is when Vitrakvi’s patent 11,337,967 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 larotrectinib sulfate be the same as Vitrakvi?
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 Vitrakvi?
Not yet. The FDA Orange Book lists no approved generic version of Vitrakvi.
When does the Vitrakvi patent expire?
The FDA Orange Book lists 20 patents for Vitrakvi; the last runs to May 2037. The one behind the expected month is patent 11,337,967, which ends in May 2037. 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 2037) weighs all of that.
Has anyone challenged the Vitrakvi patents?
Yes. The first patent challenge to Vitrakvi reached the FDA in May 2025, 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 May 2037 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
- Lotemax SMLoteprednol Etabonate2031 to 2032
- TpoxxTecovirimatSeptember 2031
- ZecuitySumatriptan SuccinateOctober 2032
- Furoscix ReadyFlowFurosemideJanuary 2040
- CabenuvaCabotegravir and RilpivirineOctober 2040
- Primatene MistEpinephrineTBD no date yet
About Vitrakvi
- Generic name larotrectinib sulfate
- How it is taken By mouth
- Company Bayer Healthcare Pharmaceuticals Inc
- Patent challenges Since May 2025 (FDA)
- More drugs Brand-name drugs starting with V
- Have a question? A pharmacist answers, free. Ask about Vitrakvi
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.