Viewing data from:

PROSCAR

NDA

FINASTERIDE | N020180 | ORGANON LLC A SUB OF ORGANON AND CO

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition Post- Finasteride Syndrome Foundation FDA-2017-P-5787 · 227 docket documents The Post-Finasteride Syndrome Foundation, a patient advocacy organization, filed this citizen petition on September 18, 2017, under Sections 352 and 355(e) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA either withdraw marketing approval for Propecia and generic finasteride 1 mg	Other	2017-09-19	Partially Denied	—

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

Clinical Trials

55 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 38 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy NCT04288427	N/A	Recruiting	Beth Israel Deaconess Medical Center	120	2020-09-25 → 2026-11-30
Sleep Apnea in Elderly NCT02703220	Phase 4	Recruiting	VA Office of Research and Development	100	2015-07-03 → 2026-07-31
High Risk Prostate Cancer Prevention Study NCT01174953	N/A	Completed	University of Kansas	18	2010-07 → 2013-03
Comparative Health Research Outcomes of NOvel Surgery in Prostate Cancer NCT04049747	N/A	Completed	Imperial College London	100	2019-12-11 → 2023-03-20
Bioequivalence Study of Finasteride 5 mg Tablet Formulations Under Fasting Conditions NCT01264289	Phase 1	Completed	Dr. Reddy's Laboratories Limited	26	2006-11 → 2006-11
A Safety and Efficacy Study of Setipiprant Tablets in Androgenetic Alopecia in Males NCT02781311	Phase 2	Completed	Allergan	169	2016-07-14 → 2018-05-22
PK Comparison of GL2701 With Finasteride and Tamsulosin in Combination NCT01829893	Phase 1	Completed	Korea University Anam Hospital	26	2012-01 → 2012-02
Enzalutamide & Dutasteride/Finasteride as 1st Line Treatment for Patients =/> 65 Years Old With Prostate Cancer.NCT02213107	Phase 2	Completed	University of Rochester	43	2014-09 → 2023-10-31
Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-Fasting Conditions NCT01264302	Phase 1	Completed	Dr. Reddy's Laboratories Limited	26	2006-11 → 2006-11

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$5.70

per ea

Lowest NADAC/Unit

$5.70

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206015301PROSCAR 5 MG TABLET	$5.70	EA	Brand	$0.0689	2026-06-17
78206015302PROSCAR 5 MG TABLET	$5.70	EA	Brand	$0.0689	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$122.68

Highest Price

$560.62

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0153-01PROSCAR 5MG TAB	$168.18	FSS	Organon LLC	01/14/2027
78206-0153-01PROSCAR 5MG TAB	$122.68	Big4	Organon LLC	01/14/2027
78206-0153-02PROSCAR 5MG TAB	$560.62	FSS	Organon LLC	01/14/2027
78206-0153-02PROSCAR 5MG TAB	$409.56	Big4	Organon LLC	01/14/2027

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

Medicare Part D Spending

CMS annual spending data for Proscar (2024)

Total Spending

$406K

Total Claims

1,210

Beneficiaries

323

Avg Cost/Unit

$5.07

Spending Trend

$127K(2021)→$470K(2022)→$459K(2023)→$406K(2024)

YoY Change:-4.1%

5yr CAGR:+3.6%

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

API Supply Chain9 active DMFs5 inactive

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

CIPLA LTDFINASTERIDE USP

DMF 157782001

DR REDDYS LABORATORIES LTDFINASTERIDE USP (FORM III)

DMF 160102002

STERLING SPAFINASTERIDE

DMF 184832005

APITORIA PHARMA PRIVATE LTDFINASTERIDE USP

DMF 193082006

HETERO LABS LTDFINASTERIDE

DMF 208932007

MSN LABORATORIES PRIVATE LTDFINASTERIDE USP

DMF 212762008

SUN PHARMACEUTICAL INDUSTRIES LTDFINASTERIDE USP

DMF 213002008

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDFINASTERIDE

DMF 250562011

DR REDDYS LABORATORIES LTDFINASTERIDE - USP (FORM-I)

DMF 437322026

GEDEON RICHTER PLCInactiveFINASTERIDE USP

DMF 175752004

CIPLA LTDInactiveFINASTERIDE USP

DMF 176802004

CRYSTAL PHARMA SAUInactiveFINASTERIDE

DMF 185512005

DR REDDYS LABORATORIES LTDInactiveFINASTERIDE (FORM I)

DMF 205212007

YUAN XINYANInactiveFINASTERIDE (API)

DMF 226752009

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

Approval Letters

18 letters from Drugs@FDA

Date	Submission	Document
Mar 20, 2026	SUPPL -50	View Letter (PDF)
Aug 27, 2021	SUPPL -49	View Letter (PDF)
Jun 16, 2021	SUPPL -47	View Letter (PDF)
Apr 14, 2021	SUPPL -48	View Letter (PDF)
Mar 13, 2014	SUPPL -44	View Letter (PDF)
Jan 22, 2013	SUPPL -43	View Letter (PDF)
Apr 12, 2012	SUPPL -41	View Letter (PDF)
Apr 12, 2012	SUPPL -40	View Letter (PDF)
Apr 12, 2012	SUPPL -42	View Letter (PDF)
Jun 17, 2011	SUPPL -35	View Letter (PDF)
Jun 10, 2011	SUPPL -39	View Letter (PDF)
Oct 7, 2010	SUPPL -37	View Letter (PDF)
Mar 29, 2010	SUPPL -33	View Letter (PDF)
Apr 29, 2004	SUPPL -29	View Letter (PDF)
Apr 20, 2004	SUPPL -26	View Letter (PDF)
Sep 30, 2003	SUPPL -20	View Letter (PDF)
Sep 25, 2003	SUPPL -27	View Letter (PDF)
Jul 6, 2003	SUPPL -25	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 19, 1992

No patent or exclusivity listings for this strength.