Kisqali Generic: When Will Generic Ribociclib 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
Kisqali Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? July to September 2031 A 3-month window 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? October 2036 12 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 ribociclib succinate is expected to be available between July and September 2031. None is for sale yet.
Why July to September 2031?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it very likely: few things could still move it, but a court ruling or a new deal can.
If Kisqali’s last patent runs to October 2036, how can a generic come sooner?
The 7 patents that run past the expected month, to October 2036 (9,193,732, 9,868,739, 12,544,379, 12,544,380 and 3 more), cover the active ingredient, the product’s formulation and a way of using it. 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. Here, a settlement between the companies sets the date. Generic companies have been challenging Kisqali’s patents with the FDA since March 2021. 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, and more so as more companies sell one. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $346.95 pharmacies pay per tablet for Kisqali today to about $93.68. See the price estimate
What should I do now?
Keep taking Kisqali 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.
Kisqali by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Very likely Few things could still move it, but a court ruling or a new deal can.
- Price competition
- Strong 5 companies have filed, 3 first in line
- Brand sales
- $4.2B a yearBlockbuster
- FDA approved 2017 March 2017 FDA Orange Book
- Patents listed 12 last runs to October 2036 A generic is expected sooner, between July and September 2031. See why FDA Orange Book
- Pharmacies pay $346.95 per tablet NADAC, October 2026
- Medicare Part D spent $1.8B in 2025, for 17.4K people CMS Part D Spending by Drug
- Medicaid prescriptions 24.2K in the last four reported quarters, $386.8M CMS Medicaid drug utilization, to Q1 2026
Kisqali’s Road to a Generic
Kisqali has had the market to itself since the FDA approved it in March 2017 (Novartis Pharmaceuticals Corp). Its FDA protection (pediatric) runs to January 2030. Its 12 listed patents run to October 2036. Generic companies have challenged its patents with the FDA since March 2021.
The first generic of Kisqali is expected between July and September 2031.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before October 2036
The last listed patent runs to October 2036; 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.
Kisqali Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Kisqali’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.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,324,225 | The active ingredient; the product’s formulation | December 2028 with the pediatric extension | Active |
| 9,416,136 | A way of using it (U-2355, U-2356, U-1981, U-3999, U-3266, U-3265, U-3975) | February 2030 with the pediatric extension | Active |
| 8,962,630 | A way of using it (U-1981, U-2356, U-2355, U-3999, U-3265, U-3266, U-3975) | June 2030 with the pediatric extension | Active |
| 8,685,980 | The active ingredient; the product’s formulation | November 2030 with the pediatric extension | Active |
| 8,415,355 | The active ingredient; the product’s formulation | September 2031 with the pediatric extension | Active |
| 9,193,732 | The active ingredient; the product’s formulation | May 2032 with the pediatric extension | Active |
| 9,868,739 | A way of using it (U-2355, U-2356, U-3999, U-1981, U-3975, U-3265, U-3266) | May 2032 with the pediatric extension | Active |
| 12,544,379 | A way of using it (U-3975) | February 2035 with the pediatric extension | Active |
| 12,544,380 | A way of using it (U-4404, U-4405) | February 2035 with the pediatric extension | Active |
| 10,799,506 | The product’s formulation | October 2036 with the pediatric extension | Active |
| 12,064,434 | The product’s formulation | October 2036 with the pediatric extension | Active |
| 12,419,894 | The product’s formulation | October 2036 with the pediatric extension | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New use I-950 | Three years of protection for a newly approved use (indication). | September 2027 | Active |
| New clinical information M-14 | Three years of protection for a change backed by new clinical studies. | July 2029 | Active |
| Pediatric PED | Six more months, earned by studying the medicine in children. | January 2030 | Active |
Source: FDA Orange Book, application 209092. Patent numbers open the patent on Google Patents.
Patent Challenges to Kisqali
The first patent challenge to Kisqali reached the FDA in March 2021, from 4 companies 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 Kisqali’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 | |||||
| Tablets, 200 mg | March 2021 | 4 companies | No decision yet | Not yet | Not yet | April 2036 |
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 Ribociclib Succinate
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
5 companies have applied to the FDA to make generic ribociclib succinate.
The FDA names a company only once it approves its application, even tentatively, and it has not done that for these yet, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. 3 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Kisqali’s patents with the FDA since March 2021: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic ribociclib succinate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic ribociclib succinate 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).
Kisqali Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Kisqali 400 mg daily dose
$346.95 per tablet in October 2026.
Hover over or tap anywhere on the chart to see that month’s price.
- Kisqali 400 mg daily dose $346.95 per tablet
- Kisqali 600 mg daily dose $289.72 per tablet
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $346.95 |
| September 2026 | $346.95 |
| August 2026 | $346.95 |
| July 2026 | $346.95 |
| June 2026 | $346.95 |
| May 2026 | $346.95 |
| April 2026 | $346.94 |
| March 2026 | $347.41 |
| February 2026 | $347.41 |
| January 2026 | $347.41 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Kisqali today: $346.95 per tablet for Kisqali 400 mg daily dose in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price 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). Kisqali has 5 companies lined up, so our estimate uses the figure for four companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $346.95 pharmacies pay per tablet today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
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 Kisqali
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 Kisqali, before manufacturer rebates.
- $556.5M
- January to March 2026, the latest CMS has posted
For 14,714 people, about $14,661 per prescription fill - $1.8B
- 2025, the whole year
For 17,371 people, about $15,175 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $556,454,043 | 14,714 | $14,660.50 |
| 2025 | $1,757,782,320 | 17,371 | $15,174.62 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Kisqali only, so no generic is counted in it. What CMS says it is used for: Ribociclib is used to treat breast cancer. It works by slowing or stopping the growth of cancer cells.
Medicaid Prescriptions by Quarter
24,221 prescriptions in the four quarters to Q1 2026, $386.8M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 6,677 | $103,131,716 |
| Q4 2025 | 6,532 | $103,395,231 |
| Q3 2025 | 5,999 | $97,294,502 |
| Q2 2025 | 5,013 | $83,006,968 |
| Q1 2025 | 4,440 | $73,305,996 |
Source: CMS Medicaid State Drug Utilization Data, over Kisqali’s own package codes.
Kisqali Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 200MG BASE | Tablet | Oral | March 2017 | Prescription reference product |
Source: FDA Orange Book, Novartis Pharmaceuticals Corp. Listed for sale today by Novartis Pharmaceuticals Corporation (FDA NDC Directory).
Kisqali NDC Codes and Packages
Each Kisqali 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 |
|---|---|---|---|
| 00078-0860-01 | RIBOCICLIB SUCCINATE 200 mg/1 tablet, film coated | blister pack of 21 tablets | Novartis Pharmaceuticals Corporation |
| 00078-0860-01 | RIBOCICLIB SUCCINATE 200 mg/1 tablet, film coated | blister pack of 21 tablets | Novartis Pharmaceuticals Corporation |
| 00078-0867-42 | RIBOCICLIB SUCCINATE 200 mg/1 tablet, film coated | carton of 3 blister packs of 14 tablets | Novartis Pharmaceuticals Corporation |
| 00078-0867-42 | RIBOCICLIB SUCCINATE 200 mg/1 tablet, film coated | carton of 3 blister packs of 14 tablets | Novartis Pharmaceuticals Corporation |
| 00078-0874-63 | RIBOCICLIB SUCCINATE 200 mg/1 tablet, film coated | carton of 3 blister packs of 21 tablets | Novartis Pharmaceuticals Corporation |
| 00078-0874-63 | RIBOCICLIB SUCCINATE 200 mg/1 tablet, film coated | carton of 3 blister packs of 21 tablets | Novartis Pharmaceuticals Corporation |
Source: the FDA NDC Directory, current listings only. Only packages sold under Kisqali’s own FDA approval (NDA 209092) are listed, never a generic. Some codes belong to companies that repackage Kisqali: it is the same medicine in a different package.
What a Generic Kisqali Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Kisqali 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 Kisqali”. 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 Kisqali
Is there a generic for Kisqali right now?
No. As of October 9, 2026 no generic ribociclib succinate is listed for sale in the FDA NDC Directory.
When will Kisqali go generic?
July to September 2031 is the expected window, and that is very likely but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to October 2036; a court ruling or a settlement can bring a generic sooner.
Will generic ribociclib succinate be the same as Kisqali?
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. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic, which would take the $346.95 pharmacies pay per tablet for Kisqali today to about $93.68. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Kisqali?
Not yet. The FDA Orange Book lists no approved generic version of Kisqali.
When does the Kisqali patent expire?
The FDA Orange Book lists 12 patents for Kisqali; the last runs to October 2036, counting a six-month pediatric extension. 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 window on this page (July to September 2031) weighs all of that.
Has anyone challenged the Kisqali patents?
Yes. The first patent challenge to Kisqali reached the FDA in March 2021, from 4 companies 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.
How much does Kisqali cost now?
Pharmacies paid about $346.95 per tablet for Kisqali 400 mg daily dose in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected July to September 2031 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
- ReyvowLasmiditan Succinate2030 to 2031
- ZykadiaCeritinibFebruary 2032
- CtexliChenodiolFebruary 2032
- VafseoVadadustat2034 to 2035
- MyfembreeEstradiol, Norethindrone Acetate, and Relugolix2034 to 2035
- IbtroziTaletrectinib AdipateJune 2038
About Kisqali
- Generic name ribociclib succinate
- How it is taken By mouth
- Company Novartis Pharmaceuticals Corp
- Patent challenges Since March 2021 (FDA)
- More drugs Brand-name drugs starting with K
- Have a question? A pharmacist answers, free. Ask about Kisqali
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, NADAC (CMS), 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.