Prescription medicine
Ribociclib Brand names: Kisqali
Ribociclib (Kisqali) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $289.72 per unit (Kisqali 600 mg daily dose) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the ribociclib FDA label on DailyMed (effective July 1, 2026, Novartis Pharmaceuticals Corporation); the NDA 209092 record on Drugs@FDA; every ribociclib label on DailyMed.
Highlights of the record
FDA label of July 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageKISQALI is a kinase inhibitor indicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.
Forms and strengths
- 200 mg
Film-coated tablet.
On the market
- Earliest approval on file
- March 13, 2017 Kisqali, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 14, 2036 Kisqali tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $289.72 per unit Kisqali 600 mg daily dose
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 31,378 through July 30, 2026
What is ribociclib used for?
From the label: indications and usageKISQALI is a kinase inhibitor indicated: in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence. ( 1 ) for the treatment of adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with: an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy. […]
Conditions named in the indications of ribociclib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (KISQALI), Novartis Pharmaceuticals Corporation, effective July 1, 2026 (SPL set aaeaef94-f3f5-4367-8ea2-b181d7be2da8), via openFDA; the full label on DailyMed
What does the patient leaflet for ribociclib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about KISQALI?KISQALI may cause serious side effects, including: Lung problems. KISQALI may cause severe or life-threatening inflammation of the lungs during treatment that may lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including: trouble breathing or shortness of breath cough with or without mucus chest pain Severe skin reactions. Tell your healthcare provider or get medical help right away if you get severe rash or rash that keeps getting worse, reddened skin, flu-like symptoms, skin pain or burning, blistering of the lips, eyes or mouth, blisters on the skin or skin peeling, with or without fever. Heart rhythm problems (QT prolongation). KISQALI can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Your healthcare provider should check your heart and do blood tests before and during treatment with KISQALI. Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or if you feel dizzy or faint. Liver problems. KISQALI can cause serious liver problems. Your healthcare provider should do blood tests to check your liver before and during treatment with KISQALI. Tell your healthcare provider right away if you get any of the following signs and symptoms of liver problems: o yellowing of your skin or the whites of your eyes (jaundice) o dark or brown (tea-colored) urine o feeling very tired o loss of appetite o pain on the upper right side of your stomach area (abdomen) o bleeding or bruising more easily than normal Low white blood cell counts (neutropenia). Low white blood cell counts are very common during treatment with KISQALI and may result in infections that may be severe. […]
From the patient leaflet: How should I store KISQALI?Store KISQALI at room temperature between 68°F to 77°F (20°C to 25°C). Store KISQALI in the original blister package in order to protect from moisture. Keep KISQALI and all medicines out of the reach of children.
Source: FDA drug label (KISQALI), Novartis Pharmaceuticals Corporation, effective July 1, 2026 (SPL set aaeaef94-f3f5-4367-8ea2-b181d7be2da8), via openFDA; the full label on DailyMed
Is there a generic for ribociclib (Kisqali)?
No generic ribociclib is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 12 patents for Kisqali tablets: the compound patent runs to November 9, 2031 (pediatric exclusivity to May 9, 2032), and the last listed entry to October 14, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ribociclib (Kisqali)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $289.72 per unit (Kisqali 600 mg daily dose), down 1% from $292.68 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Kisqali 600 mg daily dose (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Kisqali 400 mg daily dose | Brand | $346.95 per unit | n/a | n/a |
| Kisqali 600 mg daily dose | Brand | $289.72 per unit | n/a | -1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the ribociclib label say about other medicines?
The ribociclib label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name ribociclib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fulvestrant | warnings and precautions | In patients with advanced or metastatic breast cancer (MONALEESA-2, MONALEESA-3, and MONALEESA-7) who received 600 mg KISQALI plus NSAI or fulvestrant, 15 out of 1054 patients (1.4%) had a > 500 ms post-baseline QTcF value and 61 out of 1054 patients (6%) had a > 60 ms QTcF increase from baseline. |
| Tamoxifen | warnings and precautions | Avoid using KISQALI with drugs known to prolong QT interval and/or strong CYP3A inhibitors. ( 2.2 , 5.3 , 7.1 , 7.4 ) Increased QT Prolongation with Concomitant Use of Tamoxifen: |
Other labels that name ribociclib
Source: FDA drug label (KISQALI), Novartis Pharmaceuticals Corporation, effective July 1, 2026 (SPL set aaeaef94-f3f5-4367-8ea2-b181d7be2da8), via openFDA; the full label on DailyMed
What do FAERS reports show for ribociclib?
The FDA Adverse Event Reporting System holds 31,378 reports that list ribociclib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,597 are coded as a death and 7,206 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ribociclib?
17 other medicines are given the same way (oral) and in the same FDA class as ribociclib or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Everolimus | Breast cancer | 14 labelers | $26.32 per tablet 10 mg tablet | A presentation being discontinued |
| Palbociclib | Breast cancer | none listed | n/a | A presentation being discontinued |
| Abemaciclib | Breast cancer | none listed | n/a | No current entry |
| Lapatinib ditosylate | Breast cancer | 3 labelers | n/a | No current entry |
| Tucatinib | Breast cancer | none listed | n/a | No current entry |
| Neratinib | Breast cancer | none listed | n/a | No current entry |
| Anastrozole | Breast cancer | 24 labelers | $0.142 per tablet 1 mg tablet | No current entry |
| Letrozole | Breast cancer | 19 labelers | $0.145 per tablet 2.5 mg tablet | No current entry |
Every medicine labeled for the same conditions as ribociclib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ribociclib
- 17 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Ribociclib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other