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SILODOSIN

ANDA

SILODOSIN | A204726 | CHARTWELL RX SCIENCES LLC

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Kissei Pharmaceutical Co. Ltd. et al v. Sandoz Inc. 1:2013cv01092 1 patentANDA 204726silodosin	D. Del.	2013-06-17	Terminated 2017-04-13	—

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

Medicare Part D Spending

CMS annual spending data for Silodosin (2023)

Total Spending

$29.5M

Total Claims

234,111

Beneficiaries

65,592

Avg Cost/Unit

$2.03

Spending Trend

$32.2M(2019)→$29.6M(2020)→$26.0M(2021)→$26.8M(2022)→$29.5M(2023)

YoY Change:-0.5%

5yr CAGR:-10.9%

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

API Supply Chain16 active DMFs

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

ZYDUS LIFESCIENCES LTDSILODOSIN

DMF 262512012

HETERO DRUGS LTDSILODOSIN

DMF 264232012

OLON SPASILODOSIN

DMF 264592012

MSN LABORATORIES PRIVATE LTDSILODOSIN [ROUTE CODE - "SD"]

DMF 269572013

ALP PHARM BEIJING CO LTDSILODOSIN

DMF 270822013

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDSILODOSIN

DMF 295182015

ALEMBIC PHARMACEUTICALS LTDSILODOSIN

DMF 296592015

VERANOVA LPSILODOSIN

DMF 297772016

TORRENT PHARMACEUTICALS LTDSILODOSIN

DMF 310292016

APITORIA PHARMA PRIVATE LTDSILODOSIN

DMF 313162017

MACLEODS PHARMACEUTICALS LTDSILODOSIN

DMF 313592017

METROCHEM API PRIVATE LTDSILODOSIN

DMF 345382020

METROCHEM API PRIVATE LTDSILODOSIN BETA FORM

DMF 361322021

SWATI SPENTOSE PRIVATE LTDSILODOSIN

DMF 363622023

SICHUAN QINGMU PHARMACEUTICAL CO LTDSILODOSIN

DMF 385652023

METROCHEM API PRIVATE LTDSILODOSIN GAMMA FORM

DMF 405962024

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 5, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 4MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Mar 31, 2017

No patent or exclusivity listings for this strength.

#002 — 8MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Mar 31, 2017