Imkeldi Generic: When Will Generic Imatinib 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
Imkeldi Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? April 2040 About 13.5 years away Why then?
- Has the FDA approved a generic? December 2015 12 companies approved
- When does the last patent end? April 2040 Its only patent listed with the FDA
- Can you buy a generic today? Yes 34 companies list one
It already is. A generic imatinib mesylate is listed for sale by 34 companies, so ask your pharmacy whether it can fill your prescription with one.
Why April 2040?
It is when Imkeldi’s patent 11,957,681 ends. That patent covers the product’s formulation, 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.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Imkeldi, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Imkeldi 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
- Sales not reported
- FDA approved 2024 November 2024 FDA Orange Book
- Patents listed 1 last runs to April 2040 FDA Orange Book
- Generics FDA-approved 12 companies, the first approved December 2015 FDA Orange Book
- Medicare Part D spent $210.8K in 2025, for 22 people CMS Part D Spending by Drug
Imkeldi’s Road to a Generic
Imkeldi has had the market to itself since the FDA approved it in November 2024 (Shorla Oncology). Its one listed patent runs to April 2040.
The first generic of Imkeldi is expected in April 2040.
Why that month: patent 11,957,681, on the product’s formulation, 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.
Imkeldi Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Imkeldi’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 11,957,681, which ends in April 2040, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 11,957,681 Sets the expected month of generic availability | The product’s formulation | April 2040 | Active |
Source: FDA Orange Book, application 219097. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Imatinib Mesylate
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 application count is on record for Imkeldi, but the FDA has already approved 12 companies (step 2), and every approval starts with an application.
Approved by the FDA
The FDA has approved generic versions from 12 companies, the first in December 2015. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic imatinib mesylate is listed for sale by 34 companies. Ask your pharmacy whether it can fill your prescription with it.
American Health Packaging, Amneal Pharmaceuticals LLC, Apotex Corp, Archis Pharma LLC, Areva Pharmaceuticals, Armas Pharmaceuticals Inc. and 28 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Teva Pharmaceuticals USA | August 2016 | EQ 100MG BASE, EQ 400MG BASE | AB |
| Apotex Inc | August 2016 | EQ 100MG BASE, EQ 400MG BASE | AB |
| Mylan Pharmaceuticals Inc | June 2017 | EQ 100MG BASE, EQ 400MG BASE | AB |
| Dr Reddys Laboratories Ltd | August 2018 | EQ 100MG BASE, EQ 400MG BASE | AB |
| Chartwell Rx Sciences LLC | January 2019 | EQ 100MG BASE, EQ 400MG BASE | AB |
| Shilpa Medicare Ltd | January 2019 | EQ 100MG BASE, EQ 400MG BASE | AB |
| Natco Pharma Ltd | March 2019 | EQ 100MG BASE, EQ 400MG BASE | AB |
| Zydus Pharmaceuticals USA Inc | April 2020 | EQ 100MG BASE, EQ 400MG BASE | AB |
| Eugia Pharma Specialities Ltd | July 2020 | EQ 100MG BASE, EQ 400MG BASE | AB |
| Qilu Pharmaceutical Hainan Co Ltd | June 2022 | EQ 100MG BASE, EQ 400MG BASE | AB |
| Hetero Labs Ltd Unit V | April 2025 | EQ 100MG BASE, EQ 400MG BASE | AB |
| Cspc Ouyi Pharmaceutical Co Ltd | April 2025 | EQ 100MG BASE, EQ 400MG BASE | AB |
| Sun Pharmaceutical Industries Ltd discontinued | December 2015 | EQ 100MG BASE, EQ 400MG BASE | – |
| Hikma Pharmaceuticals USA Inc discontinued | July 2018 | EQ 100MG BASE, EQ 400MG BASE | – |
| Amneal Pharmaceuticals Of New York LLC discontinued | February 2019 | EQ 100MG BASE, EQ 400MG BASE | – |
| Novitium Pharma LLC discontinued | February 2019 | EQ 100MG BASE, EQ 400MG BASE | – |
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).
Imkeldi 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 Imkeldi, 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 Imkeldi
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 Imkeldi, before manufacturer rebates.
- $73.5K
- January to March 2026, the latest CMS has posted
For 18 people, about $2,298 per prescription fill - $210.8K
- 2025, the whole year
For 22 people, about $2,292 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $73,550 | 18 | $2,298.43 |
| 2025 | $210,823 | 22 | $2,291.56 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Imkeldi 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 acute lymphoblastic leukemia, chronic myeloid leukemia, gastrointestinal stromal tumors, and myelodysplastic/myeloproliferative diseases). It works by slowing or stopping the growth of cancer cells.
Imkeldi Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 80MG BASE/ML | Solution | Oral | November 2024 | Prescription reference product |
Source: FDA Orange Book, Shorla Oncology. Listed for sale today by Shorla Oncology Inc., (FDA NDC Directory).
Imkeldi NDC Codes and Packages
Each Imkeldi 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 |
|---|---|---|---|
| 81927-0201-01 | IMATINIB MESYLATE 80 mg/mL solution | bottle of 140 mL | Shorla Oncology Inc., |
Source: the FDA NDC Directory, current listings only. Only packages sold under Imkeldi’s own FDA approval (NDA 219097) are listed, never a generic. Some codes belong to companies that repackage Imkeldi: it is the same medicine in a different package.
What a Generic Imkeldi Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
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.
Questions people ask about Imkeldi
Is there a generic for Imkeldi right now?
Yes. The FDA NDC Directory lists a generic imatinib mesylate from 34 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Imkeldi go generic?
It already has. The FDA NDC Directory lists a generic imatinib mesylate from 34 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic imatinib mesylate be the same as Imkeldi?
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. The FDA has already approved 12 companies to make a generic, and how many of them launch decides how far the price falls.
Has the FDA approved a generic Imkeldi?
Yes. The FDA Orange Book lists approved generic versions from 12 companies, the first approved in December 2015: Teva Pharmaceuticals USA, Apotex Inc, Mylan Pharmaceuticals Inc, Dr Reddys Laboratories Ltd and 8 more. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Imkeldi patent expire?
One patent is listed for Imkeldi in the FDA Orange Book; it runs to April 2040. The one behind the expected month is patent 11,957,681, which ends in April 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 (April 2040) weighs all of that.
Changes to This Projection
- First generic expected April 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
- LastacaftAlcaftadine2026 to 2027
- PerserisRisperidoneFebruary 2028
- Bevespi AerosphereFormoterol Fumarate and GlycopyrrolateMarch 2031
- EysuvisLoteprednol EtabonateMay 2033
- XolremdiMavorixaforApril 2038
- TauklarifyFlorquinitau F18June 2040
About Imkeldi
- Generic name imatinib mesylate
- How it is taken By mouth
- Company Shorla Oncology
- More drugs Brand-name drugs starting with I
- Have a question? A pharmacist answers, free. Ask about Imkeldi
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.