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

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Prostate Specific Membrane Antigen (PSMA) Imaging for Detection of Residual and Metastatic Prostate Cancer NCT07593079	Phase 2	Not Yet Recruiting	Washington University School of Medicine	20	2026-07-31 → 2027-10-31
Bicalutamide With or Without Akt Inhibitor MK2206 in Treating Patients With Previously Treated Prostate Cancer NCT01251861	Phase 2	Completed	National Cancer Institute (NCI)	108	2011-03-17 → 2026-05-26

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

Medicare Part D Spending

CMS annual spending data for Casodex (2023)

Total Spending

$381K

Total Claims

Beneficiaries

Avg Cost/Unit

$105.07

Spending Trend

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

YoY Change:+13.3%

5yr CAGR:+3.1%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain9 active DMFs20 inactive

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

TEVA PHARMACEUTICAL INDUSTRIES LTDBICALUTAMIDE

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.