Viewing data from:

AVODART

NDA

DUTASTERIDE | N021319 | WAYLIS THERAPEUTICS LLC

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
GlaxoSmithKline LLC v. Banner Pharmacaps Inc. et al 1:2011cv00046 3 patentsANDA 202530, 202509dutasteride	D. Del.	2011-01-12	Terminated 2013-08-26	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Avodart (2023)

Total Spending

$4.2M

Total Claims

4,199

Beneficiaries

946

Avg Cost/Unit

$15.95

Spending Trend

$4.2M(2019)→$3.5M(2020)→$3.0M(2021)→$2.9M(2022)→$4.2M(2023)

YoY Change:+100.3%

5yr CAGR:+25.4%

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

API Supply Chain9 active DMFs8 inactive

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

STERLING SPADUTASTERIDE

DMF 209182007

MSN LABORATORIES PRIVATE LTDDUTASTERIDE USP [ROUTE CODE - "DT"]

DMF 235332010

DR REDDYS LABORATORIES LTDDUTASTERIDE (PROCESS-II) USP

DMF 264752012

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDDUTASTERIDE

DMF 268032013

HUBEI GEDIAN HUMANWELL PHARMACEUTICAL CO LTDDUTASTERIDE ACID

DMF 277632013

HETERO LABS LTDDUTASTERIDE

DMF 277742013

APITORIA PHARMA PRIVATE LTDDUTASTERIDE USP

DMF 295772015

STERLING CHEMICAL MALTA LTDDUTASTERIDE FORM I

DMF 301432015

MSN LABORATORIES PRIVATE LTDDUTASTERIDE USP

DMF 330632018

CATALENT FRANCE BEINHEIM SAInactiveDUTASTERIDE SOFT GELATIN CAPSULES .5MG

DMF 146431999

DR REDDYS LABORATORIES LTDInactiveDUTASTERIDE (Process-I)

DMF 184082005

CIPLA LTDInactiveDUTASTERIDE

DMF 201802009

FIS FABBRICA ITALIANA SINTETICI SPAInactiveDUTASTERIDE

DMF 234942010

GADOR SAInactiveDUTASTERIDE

DMF 238102010

CATALENT PHARMA SOLUTIONS LLCInactiveDUTASTERIDE 0.5 MG SOFT GELATIN CAPSULES

DMF 243042010

RELIANCE LIFE SCIENCES PVT LTDInactiveDUTASTERIDE

DMF 248802011

IND SWIFT LABORATORIES LTDInactiveDUTASTERIDE USP

DMF 277882014

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

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Feb 4, 2020	SUPPL -32	View Letter (PDF)
May 2, 2013	SUPPL -29	View Letter (PDF)
May 2, 2013	SUPPL -28	View Letter (PDF)
Jun 29, 2012	SUPPL -27	View Letter (PDF)
Jun 10, 2011	SUPPL -23	View Letter (PDF)
Jun 10, 2011	SUPPL -25	View Letter (PDF)
Sep 13, 2010	SUPPL -22	View Letter (PDF)
Jun 18, 2010	SUPPL -18	View Letter (PDF)
Jun 23, 2008	SUPPL -14	View Letter (PDF)
Apr 2, 2008	SUPPL -15	View Letter (PDF)
Jan 6, 2006	SUPPL -9	View Letter (PDF)
Sep 15, 2004	SUPPL -8	View Letter (PDF)
Aug 6, 2004	SUPPL -7	View Letter (PDF)
Mar 19, 2004	SUPPL -5	View Letter (PDF)
Oct 9, 2002	SUPPL -1	View Letter (PDF)
Nov 20, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Nov 20, 2001

No patent or exclusivity listings for this strength.