Quick answers
- What is Everolimus used for?
- The FDA-approved label (Afinitor, Novartis Pharmaceuticals Corporation, June 1, 2026) says: “AFINITOR is a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Everolimus have a boxed warning?
- The label we quote has no boxed warning, but 6 of 17 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Everolimus?
- The FDA drug shortage list shows “To be discontinued” for a product of this medicine (updated October 14, 2026). Ask your pharmacist about alternatives.
- Has Everolimus been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Everolimus?
- 15 companies list prescription products of Everolimus in the FDA NDC Directory, including Novartis Pharmaceuticals Corporation, Breckenridge Pharmaceutical, Inc. and Biocon Pharma Inc..
What Everolimus is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AFINITOR is a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. …
— FDA label: Afinitor, Novartis Pharmaceuticals Corporation, effective June 1, 2026. Read the full label on DailyMed →
The FDA has 17 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
6 of 17 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, for suspension |
|---|---|
| Route | Oral |
| Prescription products | 85 in the FDA NDC Directory |
| Brand names | Yulithira, Zortress, Afinitor, Torpenz, Afinitor Disperz |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| everolimus 0.25 mg tablet | Generic | $1.69 per tablet |
| everolimus 0.5 mg tablet | Generic | $3.20 per tablet |
| everolimus 0.75 mg tablet | Generic | $3.87 per tablet |
| everolimus 1 mg tablet | Generic | $5.49 per tablet |
| everolimus 10 mg tablet | Generic | $26.32 per tablet |
| everolimus 5 mg tablet | Generic | $14.77 per tablet |
NADAC list of November 4, 2026; these prices took effect between September 9, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Novartis Pharmaceuticals Corporation11 products
- Breckenridge Pharmaceutical, Inc.11 products
- Biocon Pharma Inc.11 products
- Natco Pharma Limited8 products
- Hikma Pharmaceuticals USA Inc.8 products
- i3 Pharmaceuticals, LLC4 products
- NorthStar RxLLC4 products
- CivicaScript LLC4 products
- Novugen Pharma (USA) LLC4 products
- Aurobindo Pharma Limited4 products
- Ascend Laboratories, LLC4 products
- Upsher-Smith Laboratories, LLC4 products
- ANI Pharmaceuticals, Inc.3 products
- Amneal Pharmaceuticals NY LLC3 products
- Par Health USA, LLC2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021560 ZORTRESS | Novartis | April 20, 2010 | 20, latest September 16, 2026 2026: Labeling · 2024: Labeling · 2023: Labeling |
| NDA022334 AFINITOR | Novartis | March 30, 2009 | 37, latest June 1, 2026 2026: Labeling · 2022: Labeling · 2021: Efficacy |
| NDA203985 AFINITOR DISPERZ | Novartis Pharm | August 29, 2012 | 17, latest June 1, 2026 2026: Labeling · 2024: Manufacturing (CMC) · 2022: Labeling |
Generic approvals (15)
- ANDA206133Hikma · April 12, 2018
- ANDA207486Hikma · June 8, 2020
- ANDA214182Biocon Pharma · February 11, 2021
- ANDA205426Breckenridge · March 5, 2021
- ANDA205432Breckenridge · May 20, 2021
- ANDA205775Ph Health · October 18, 2021
- ANDA214138Alkem Labs Ltd · November 26, 2021
- ANDA218863Amneal · January 10, 2025
- ANDA217640Natco · January 28, 2025
- ANDA216140Biocon Pharma · April 9, 2025
- ANDA219955Neocubes Pharma · October 30, 2025
- ANDA217216Biocon Pharma · January 9, 2026
- ANDA219533Eugia Pharma · February 25, 2026
- ANDA219464Pharmazone · June 30, 2026
- ANDA220597Novitium Pharma · September 21, 2026
Shortage status
To be discontinued · updated October 14, 2026 · first posted October 14, 2026
| Product | Everolimus, Tablet, .5 mg (NDC 49884-159-02) |
|---|---|
| Company | Par Health, USA LLC |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Afinitor, Novartis Pharmaceuticals Corporation, effective June 1, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →