Treats postmenopausal women with estrogen-receptor positive early breast cancer. Sold as Aromasin. Every FDA application for this active ingredient: 1 branded and 11 generic.
As of Nov 13, 2026, FDA lists 12 applications for Exemestane (sold as Aromasin), first approved Oct 21, 1999, with 2 new uses approved and 0 published complete response letters.
| Exemestane | Part D | $26.1M | -18% | 60,827 |
| Aromasin | Part D | $922K | -21% | 102 |
| A Study of Tersolisib (LY4064809) and Abemaciclib With Hormone Therapies in Participants With PIK3CA-Mutated Early Breast CancerBreast Neoplasms · Eli Lilly and Company | Phase 2 | Not yet recruiting | Nov 13, 2026 |
| Chemotherapy Exemption in Elderly Women With Node-Positive ER+/HER2- Breast CancerBreast Cancer, Adjuvant Therapy · Fudan University | Phase 2 | Not yet recruiting | Sep 17, 2026 |
| Dalpiciclib Combined With Aromatase Inhibitors and Olmesartan as the First-line Treatment for HR+/HER2- Advanced Breast CancerHR+ / HER2- Advanced Breast Cancer · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Phase 2 | Recruiting | Sep 9, 2026 |
| Neoadjuvant Culmerciclib Combined With Endocrine Therapy for Hormone Receptor-Positive， Human Epidermal Growth Factor Receptor 2-Negative Breast CancerHormone Receptor-Positive Breast Cancer, HER2 Low Breast Carcinoma · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Phase 2 | Recruiting | Sep 1, 2026 |
| QL1706 Plus Neoadjuvant Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer With a Poor Response to Neoadjuvant ChemotherapyBreast Cancer · Hebei Medical University Fourth Hospital | Phase 2 | Not yet recruiting | Aug 24, 2026 |
| Tai Chi for Reducing Aromatase Inhibitor-Induced ArthralgiaHormone Receptor Positive Breast Carcinoma, Postmenopausal · Thomas Jefferson University | Not applicable | Recruiting | Jul 30, 2026 |
| Neu Direction: Testing the Efficacy of Adding HER Inhibition to Standard of Care in Metastatic MLH1-low Endocrine-resistant ER+/HER2- Breast CancerMetastatic Invasive Breast Cancer, Resistant Breast Cancer · University of California, San Diego | Phase 2 | Not yet recruiting | Jul 27, 2026 |
| Entinostat Plus Pyrotinib and Endocrine Therapy in Advanced Triple-Positive Breast Cancer After Trastuzumab FailureBreast Cancer, HER2-positive Breast Cancer · Tianjin Medical University Cancer Institute and Hospital | Phase 1 / Phase 2 | Recruiting | Jul 16, 2026 |
| Oct 21, 1999 | AromasinNDA 20753 · New molecular entity | Pfizer | 17 | Marketed |
| Apr 1, 2011 | ExemestaneANDA 77431 | Hikma | 7 | Discontinued |
| Jul 28, 2014 | ExemestaneANDA 200898 | Eirgen | 4 | Marketed |
| Mar 10, 2017 | ExemestaneANDA 203315 | Rising | 2 | Marketed |
| Jul 26, 2017 | ExemestaneANDA 209208 | Upsher Smith Labs | 3 | Marketed |
| Apr 27, 2018 | ExemestaneANDA 210323 | Cipla | 3 | Marketed |
| Oct 3, 2018 | ExemestaneANDA 202602 | Zydus Pharms | 2 | Marketed |
| Dec 28, 2018 | ExemestaneANDA 206421 | Amneal Pharms | 2 | Discontinued |
| Feb 21, 2019 | ExemestaneANDA 211031 | Breckenridge | 1 | Marketed |
| Aug 8, 2019 | ExemestaneANDA 208764 | Dr Reddys Labs SA | 1 | Discontinued |
| Apr 13, 2020 | ExemestaneANDA 213547 | Qilu | 2 | Marketed |
| May 20, 2022 | ExemestaneANDA 216454 | Eugia Pharma | 1 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Pfizer
Hikma
Cipla
Zydus Pharms
Eugia Pharma