NDAORALTABLET
Approved
Oct 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
CASODEX (bicalutamide) by ANI Pharmaceuticals is androgen receptor antagonists [moa]. Approved for prostate cancer. First approved in 1995.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CASODEX (bicalutamide) is an oral androgen receptor antagonist approved in 1995 for prostate cancer and indicated off-label across multiple hematologic malignancies and solid tumors. It blocks androgen signaling by inhibiting the androgen receptor, reducing tumor proliferation in hormone-sensitive cancers. The drug has evolved from a monotherapy standard to an adjunct in modern combination regimens.
$0.381MPart D
LOE ApproachingDeclining
Mature product in decline with minimal Medicare utilization; brand teams are likely consolidating and shifting focus to newer androgen receptor inhibitors.
Mechanism of Action
Androgen Receptor Antagonists
Pharmacologic Class:
Androgen Receptor Inhibitor
Indications (1)
Clinical Trials (20)
An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment
Started Jun 2026
800 enrolled
Non-metastatic Castration-resistant Prostate Cancer
Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer
Started Apr 2024
53 enrolled
Triple Negative Breast Neoplasms
Nivolumab, Ipilimumab, and Bicalutamide in Human Epidermal Growth Factor (HER) 2 Negative Breast Cancer Patients
Started Apr 2019
30 enrolled
Breast Neoplasm FemaleBreast CancerBreast Carcinoma+1 more
Ribociclib and Bicalutamide in AR+ TNBC
Started May 2018
37 enrolled
Triple Negative Breast Cancer
Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)
Started Nov 2015
46 enrolled
Metastatic Breast Cancer (MBC)
Worked on CASODEX at ANI Pharmaceuticals? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.