Viewing data from:

CASODEX

NDA

BICALUTAMIDE | N020498 | ANI PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

148 trials from ClinicalTrials.gov — 2 recruiting, 12 active, 93 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms NCT03348670	Phase 2/3	Active	Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair	600	2023-08-18 → 2026-12-28
A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery NCT03809000	Phase 2	Active	RTOG Foundation, Inc.	188	2019-04-15 → 2029-09-15
Feasibility of Hormones and Radiation for Intermediate or High Risk Prostate Cancer NCT01342367	N/A	Active	University of Chicago	74	2010-12-17 → 2026-02
Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer NCT01786265	Phase 2	Active	M.D. Anderson Cancer Center	310	2013-02-05 → 2027-02-01
Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)NCT02605486	Phase 1/2	Active	Memorial Sloan Kettering Cancer Center	46	2015-11-11 → 2026-11
Ribociclib and Bicalutamide in AR+ TNBC NCT03090165	Phase 1/2	Active	Kari Wisinski	37	2018-05-07 → 2026-10
SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer NCT02299999	Phase 2	Active	UNICANCER	1,460	2014-04-07 → 2025-12
INTREPId (INTermediate Risk Erection PreservatIon Trial)NCT04025372	Phase 2	Active	Brigham and Women's Hospital	234	2020-06-01 → 2028-03-01
Study on the Role of Hormonal Treatment for Two Dosage Levels of Prostate Radiation Therapy Versus Prostate Radiation Therapy Alone NCT00223145	Phase 3	Active	Abdenour Nabid	600	2000-12 → 2027-12-31
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS NCT02531516	Phase 3	Active	Aragon Pharmaceuticals, Inc.	1,503	2015-11-19 → 2028-12-29

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$2308.19

Highest Price

$3246.44

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62559-0680-30CASODEX 50MG TAB	$3246.44	FSS	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027
62559-0680-30CASODEX 50MG TAB	$2308.19	Big4	ANIP Acquisition Company, d/b/a ANI Pharmaceuticals, Inc.	07/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Casodex (2024)

Total Spending

$237K

Total Claims

Beneficiaries

Avg Cost/Unit

$99.64

Spending Trend

$788K(2019)→$811K(2020)→$651K(2021)→$421K(2022)→$381K(2023)→$237K(2024)

YoY Change:-5.2%

5yr CAGR:+2.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain9 active DMFs20 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVBICALUTAMIDE

DMF 170082003

HETERO LABS LTDBICALUTAMIDE (FORM-H1)

DMF 184962005

OLON SPABICALUTAMIDE DRUG SUBSTANCE

DMF 196242006

SUN PHARMACEUTICAL INDUSTRIES LTDBICALUTAMIDE USP

DMF 202632007

AARTI PHARMALABS LTDBICALUTAMIDE

DMF 205022007

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)Bicalutamide

DMF 211032007

EXCELLA GMBH AND CO KGBICALUTAMIDE MILLED Z

DMF 218632008

SHILPA PHARMA LIFESCIENCES LTDBICALUTAMIDE USP

DMF 246902011

MSN LABORATORIES PRIVATE LTDBICALUTAMIDE USP [ROUTE CODE - "BL"]

DMF 257302012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveBICALUTAMIDE USP

DMF 178782004

CF PHARMA LTDInactiveBICALUTAMIDE

DMF 181412005

USV PRIVATE LTDInactiveBICALUTAMIDE

DMF 183742005

CIPLA LTDInactiveBICALUTAMIDE USP

DMF 187232005

GEDEON RICHTER LTDInactiveBICALUTAMIDE (MICRONIZED)

DMF 187762005

EXCELLA GMBHInactiveBICALUTAMIDE

DMF 187922005

SUMITOMO CHEMICAL CO LTDInactiveBICALUTAMIDE DRUG SUBSTANCE

DMF 193112006

COSMA SPAInactiveBICALUTAMIDE

DMF 194102006

TAI HENG INDUSTRY CO LTDInactiveBICALUTAMIDE

DMF 195462006

LUPIN LTDInactiveBICALUTAMIDE

DMF 195872006

DR REDDYS LABORATORIES LTDInactiveBICALUTAMIDE

DMF 197822006

FRESENIUS KABI ONCOLOGY LTDInactiveBICALUTAMIDE

DMF 200992006

KEKULE PHARMA LTDInactiveBICALUTAMIDE

DMF 207852007

GENESEN LABS LTDInactiveBICALUTAMIDE

DMF 213332007

AREVIPHARMA GMBHInactiveBICALUTAMIDE

DMF 216702008

CF PHARMA LTDInactiveBICALUTAMIDE ADSORBATE

DMF 221582008

SIGNA SA DE CVInactiveBICALUTAMIDE USP

DMF 227842009

MYLAN LABORATORIES LTDInactiveBICALUTAMIDE USP

DMF 246702011

EMCURE PHARMACEUTICALS LTDInactiveBICALUTAMIDE USP

DMF 249222011

MAC CHEM PRODUCTS INDIA PVT LTDInactiveBICALUTAMIDE USP

DMF 263552012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Nov 6, 2017	SUPPL -28	View Letter (PDF)
Mar 20, 2017	SUPPL -27	View Letter (PDF)
Mar 2, 2015	SUPPL -25	View Letter (PDF)
Sep 20, 2010	SUPPL -22	View Letter (PDF)
Mar 16, 2009	SUPPL -19	View Letter (PDF)
Mar 16, 2009	SUPPL -21	View Letter (PDF)
Mar 23, 2006	SUPPL -18	View Letter (PDF)
May 17, 2005	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 4, 1995

No patent or exclusivity listings for this strength.