Drug
Who makes everolimus?
16 companies list everolimus as a human prescription drug, including under the names Afinitor, Afinitor Disperz, Zortress, TORPENZ, Yulithira. Forms: tablet; tablet, for suspension. Routes: oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing everolimus
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Novartis Pharmaceuticals CorporationSwitzerland | tablet; tablet, for suspension | NDANDA021560, NDA022334, NDA203985 | 11 | 20 |
| Biocon Biologics LimitedIndia | tablet; tablet, for suspension | ANDAANDA214182, ANDA216140, ANDA217216 | 11 | 9 |
| Novartis Pharma Stein AG | tablet; tablet, for suspension | DRUG FOR FURTHER PROCESSING | 11 | 0 |
| NATCO PHARMA LIMITEDIndia | tablet | ANDAANDA205426, ANDA205432 | 8 | 5 |
| Hikma Pharmaceuticals USA Inc.United States | tablet | ANDAANDA206133, ANDA207486 | 8 | 4 |
| Breckenridge Pharmaceutical, Inc. | tablet; tablet, for suspension | ANDAANDA205426, ANDA217640 | 7 | 0 |
| Aurobindo Pharma LimitedIndia | tablet | ANDAANDA219533 | 4 | 6 |
| Teva Pharmaceutical Industries Ltd.Canada | tablet | ANDAANDA210050 | 4 | 6 |
| Par Health USA, LLCIndia | tablet | ANDAANDA205775 | 4 | 5 |
| Novugen Pharma Sdn. Bhd.Malaysia | tablet | ANDAANDA219955 | 4 | 1 |
| ASCEND Therapeutics US, LLC | tablet | ANDAANDA214138 | 4 | 0 |
| CivicaScript, LLC | tablet | ANDAANDA205426 | 4 | 0 |
| NorthStar RxLLC | tablet | ANDAANDA214182 | 4 | 0 |
| Upsher-Smith Laboratories, Inc. | tablet | ANDAANDA214182 | 4 | 0 |
| i3 Pharmaceuticals, LLC | tablet | ANDAANDA219464 | 4 | 0 |
| Amneal Pharmaceuticals NY LLC | tablet, for suspension | ANDAANDA218863 | 3 | 0 |
Bulk ingredient listings
- Biocon Biologics LimitedIndia · 3 NDC
- Chunghwa Chemical Synthesis & Biotech Co., Ltd. · 3 NDC
- Farmhispania S.A.Spain · 2 NDC
- BrightGene Bio-Medical Technology Co., Ltd.China · 1 NDC
- Concord Biotech LimitedIndia · 1 NDC
- Dr. Reddy's Laboratories LimitedIndia · 1 NDC
- MSN Laboratories Private Limited,India · 1 NDC
- NATCO PHARMA LIMITEDIndia · 1 NDC
- Novartis Pharmaceuticals CorporationSwitzerland · 1 NDC
- ScinoPharm Taiwan, Ltd.Taiwan · 1 NDC
Orange Book patents
1 unexpired patent lists everolimus as the active ingredient, expiring between Jul 2028 and Jul 2028. Application holder: NOVARTIS PHARMACEUTICALS CORP.
Enquiry
Common questions
- Who makes everolimus?
- 16 companies list everolimus as a human prescription drug in the openFDA NDC Directory, led by Novartis Pharmaceuticals Corporation, Biocon Biologics Limited, Novartis Pharma Stein AG, NATCO PHARMA LIMITED, Hikma Pharmaceuticals USA Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Afinitor?
- 14 companies list everolimus under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies everolimus active ingredient?
- 10 companies list everolimus as a bulk ingredient, including Biocon Biologics Limited, Chunghwa Chemical Synthesis & Biotech Co., Ltd., Farmhispania S.A., BrightGene Bio-Medical Technology Co., Ltd..