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NILANDRON

NDA

NILUTAMIDE | N020169 | ADVANZ PHARMA (US) CORP

2 strengths0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Foley & Lardner LLP - Citizen Petition FDA-2013-P-0335 · 3 docket documents On March 14, 2013, Foley & Lardner LLP filed a citizen petition under Section 505 of the Federal Food, Drug and Cosmetic Act requesting that FDA amend its October 2011 Guidance on Nilutamide to include an alternative bioequivalence study design consisting of two single-dose, two-way crossover studie	505(q)	2013-04-02	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

10 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer NCT03678025	Phase 3	Recruiting	SWOG Cancer Research Network	1,273	2018-09-24 → 2031-10-01
Hormone Therapy in Treating Patients With Rising PSA Levels Following Radiation Therapy for Prostate Cancer NCT00003653	Phase 3	Completed	NCIC Clinical Trials Group	1,386	1999-01-05 → 2013-01-10
Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer NCT00002633	Phase 3	Completed	NCIC Clinical Trials Group	361	1995-02-08 → 2012-01-06
Vaccine Therapy Plus Sargramostim and Interleukin-2 Compared With Nilutamide Alone in Treating Patients With Prostate Cancer NCT00020254	Phase 2	Completed	National Cancer Institute (NCI)	—	2000-06
S0032, Combination Chemotherapy Plus Hormone Therapy in Treating Patients With Metastatic Prostate Cancer NCT00028769	Phase 2	Completed	SWOG Cancer Research Network	41	2001-12 → 2011-07
Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery NCT03070886	Phase 2/3	Completed	NRG Oncology	612	2017-04-05 → 2025-10-31
Chemotherapy Plus Hormone Therapy Versus Androgen Suppression in Treating Patients With Metastatic or Unresectable Prostate Cancer NCT00002855	Phase 3	Completed	M.D. Anderson Cancer Center	306	1996-08 → 2005-06
Genomic Guided Therapy With Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer NCT00918385	Phase 2	Terminated	Duke University	57	2009-05 → 2013-08
Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer NCT00512668	Phase 1	Terminated	National Cancer Institute (NCI)	24	2007-09

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

VA Federal Supply Schedule

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

Lowest Price

$2320.48

Highest Price

$3053.27

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59212-0111-14NILANDRON 150MG TAB	$3053.27	FSS	Amdipharm Limited	09/28/2026
59212-0111-14NILANDRON 150MG TAB	$2320.48	Big4	Amdipharm Limited	09/28/2026

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

Medicare Part D Spending

CMS annual spending data for Nilandron (2024)

Total Spending

$19K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$106.55

Spending Trend

$478K(2019)→$148K(2020)→$215K(2021)→$128K(2022)→$47K(2023)→$19K(2024)

YoY Change:-1.4%

5yr CAGR:-19.9%

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

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

KEKULE PHARMA LTDNILUTAMIDE

DMF 254652011

BIOPHORE INDIA PHARMACEUTICALS PVT LTDNILUTAMIDE

DMF 282622014

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
May 19, 2017	SUPPL -8	View Letter (PDF)
Jul 28, 2004	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 19, 1996

No patent or exclusivity listings for this strength.

#002 — 150MG

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 30, 1999