Abiraterone Acetate

Treats Metastatic castration-resistant prostate cancer (CRPC) … prostate cancer (CSPC). Sold as Zytiga, Yonsa. Every FDA application for this active ingredient: 2 branded and 15 generic.

As of Nov 15, 2026, FDA lists 17 applications for Abiraterone Acetate (sold as Zytiga, Yonsa), first approved Apr 28, 2011, with 4 new uses approved and 0 published complete response letters.

First approved: Apr 28, 2011
Applications: 17
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $617M
First approved in the EU: Sep 5, 2011
First approved in Japan: Jul 4, 2014

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Abiraterone Acetate	Part D	$601M	-13%	61,053
Zytiga	Part D	$16.1M	-27%	203
Abirtega	Part D	$151K	New	432

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

ABIRATERONE ACETATE 250 MG TAB: $0.788 per unitGeneric · -25% in a year
ABIRATERONE ACETATE 500 MG TAB: $2.51 per unitGeneric · -54% in a year

Approvals in the EU (EMA)

First approved in the EU 4 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Abiraterone Mylan, genericMylan Pharmaceuticals Limited · Aug 20, 2021
Abiraterone Krka, genericKRKA tovarna zdravil d.d. Novo mesto · Jun 24, 2021
Abiraterone Accord, genericAccord Healthcare S.L.U. · Apr 26, 2021
Zytiga, new substanceJanssen-Cilag International · Sep 5, 2011

Approvals in Japan (PMDA)

First approved in Japan 38 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

ZytigaA drug with a new additional indication for the treatment of prostate cancer in patients with high- risk prognostic factors who have not received previous… · Janssen Pharmaceutical K.K. · Feb 16, 2018
Zytiga, new ingredientA drug with a new active ingredient indicated for the treatment of castration-resistant prostate cancer. · Janssen Pharmaceutical K.K. · Jul 4, 2014

Clinical Trials

107 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


MK-2870-U01 Substudy 1: A Clinical Trial of Sacituzumab Tirumotecan to Treat Prostate Cancer (MK-2870-01A)Metastatic Castration-resistant Prostate Cancer · Merck Sharp & Dohme LLC	Phase 1 / Phase 2	Not yet recruiting	Nov 2, 2026
Testing the Use of High Dose Testosterone Followed by Darolutamide Compared to the Usual Care for Patients With Metastatic Prostate CancerMetastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 · ECOG-ACRIN Cancer Research Group	Phase 2 / Phase 3	Not yet recruiting	Oct 1, 2026
Study of XNW5004 Tablets in Advanced Prostate CancerAdvanced Prostate Cancer · Evopoint Biosciences Inc.	Phase 2	Not yet recruiting	Jul 28, 2026
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)Metastatic Castration Resistant Prostate Cancer · ORIC Pharmaceuticals	Phase 3	Recruiting	Jul 23, 2026
Observing the Real-world Non-interventional Study of Abiraterone Acetate Tablets (II) in Treating Chinese Patients With Metastatic Prostate CancerDiagnosed With Metastatic Prostate Cancer · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	—	Active, not recruiting	Jul 23, 2026
Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients.Prostatic Neoplasms, Castration-Resistant · Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic	Phase 2	Recruiting	Jul 21, 2026
Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE TrialRecurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 · Mayo Clinic	Phase 2	Recruiting	Jun 16, 2026
AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)Metastatic Castration-resistant Prostate Cancer · AstraZeneca	Phase 3	Recruiting	May 28, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 28, 2011	ZytigaNDA 202379 · New molecular entity	Janssen Biotech	25	Marketed
May 22, 2018	YonsaNDA 210308 · New formulation or manufacturer	Sun Pharm	4	Marketed
Oct 31, 2018	Abiraterone AcetateANDA 208339	Hikma	4	Marketed
Oct 31, 2018	Abiraterone AcetateANDA 208432	Teva Pharms USA	2	Discontinued
Oct 31, 2018	Abiraterone AcetateANDA 208446	Mylan	5	Marketed
Oct 31, 2018	Abiraterone AcetateANDA 208453	Apotex	4	Marketed
Jan 7, 2019	Abiraterone AcetateANDA 208327	Amneal Pharms	3	Marketed
Feb 25, 2019	Abiraterone AcetateANDA 208371	Rising	1	Marketed
Feb 27, 2019	Abiraterone AcetateANDA 208380	Wockhardt Bio AG	1	Marketed
Jul 10, 2019	Abiraterone AcetateANDA 210686	Msn	3	Marketed
Sep 27, 2019	Abiraterone AcetateANDA 212462	Qilu	2	Marketed
Oct 16, 2019	Abiraterone AcetateANDA 209227	Glenmark Speclt	3	Marketed
May 18, 2020	Abiraterone AcetateANDA 208416	Dr Reddys	3	Marketed
Jan 5, 2022	Abiraterone AcetateANDA 215947	Novugen	0	Marketed
Jun 24, 2022	Abiraterone AcetateANDA 212206	Teva Pharms USA	0	Discontinued
Jan 26, 2023	Abiraterone AcetateANDA 210726	Teva Pharms USA	0	Discontinued
Mar 23, 2023	Abiraterone AcetateANDA 215086	Regcon Holdings	0	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