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Silodosin - Generic Drug Details

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What are the generic sources for silodosin and what is the scope of freedom to operate?

Silodosin is the generic ingredient in two branded drugs marketed by Allergan Sales Llc, Ajanta Pharma Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Msn Labs Pvt Ltd, and Sandoz Inc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for silodosin. Ten suppliers are listed for this compound.

Summary for silodosin

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	8
Drug Master File Entries:	12
Suppliers / Packagers:	10
Bulk Api Vendors:	74
Clinical Trials:	21
Patent Applications:	559
Drug Prices:	Drug price trends for silodosin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for silodosin
DailyMed Link:	silodosin at DailyMed

See drug prices for silodosin

Recent Clinical Trials for silodosin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	Phase 4
Sir Mortimer B. Davis - Jewish General Hospital	Phase 3
Centre Hospitalier Departemental Vendee	Phase 3

See all silodosin clinical trials

Recent Litigation for silodosin

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Kissei Pharmaceutical Co., Ltd. v. Aurobindo Pharma Ltd.	2017-08-18
Kissei Pharmaceutical Co. Ltd. v. Hetero USA Inc.	2013-06-17
Kissei Pharmaceutical Co. Ltd. v. Sandoz Inc.	2013-06-17

See all silodosin litigation

Pharmacology for silodosin

Drug Class	alpha-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists

Synonyms for silodosin

( C)-1-(3-Hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-2,3-di-hydro-1H-indole-7-carboxamide

(_)-1-(3-Hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-2,3-di-hydro-1H-indole-7-carboxamide

(-)-1-(3-Hydroxypropyl)-5-((2R)-2-((2-(2-(2,2,2-trifluoroethoxy)phenoxy)ethyl)amino)propyl)-2,3-dihydro-1H-indole-7-carboxamide

(-)-1-(3-Hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-2,3-di-hydro-1H-indole-7-carboxamide

(R)-1-(3-hydroxypropyl)-5-(2-((2-(2-(2,2,2-trifluoroethoxy)phenoxy)ethyl)amino)propyl)indoline-7-carboxamide

(R)-1-(3-Hydroxypropyl)-5-[2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]indoline-7-carboxamide

(R)-5-[2-[[2-[2-(2,2,2-trifluoro-ethoxy)phenoxy]ethyl]amino]propyl]-1-(3-hydroxypropyl)-2,3-dihydro-1H-indole-7-carboxamide

1-(3-Hydroxy-propyl)-5-((R)-2-{2-[2-(2,2,2-trifluoro-ethoxy)-phenoxy]-ethylamino}-propyl)-2,3-dihydro-1H-indole-7-carboxylic acid amide

1-(3-hydroxypropyl)-5-[(2R)-2-({2-[2-(2,2,2-trifluoroethoxy)phenoxy]-ethyl}amino)propyl]-2,3-dihydro-1H-indole-7-carboxamide

1-(3-Hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-2,3-dihydro-1H-indole-7-carboxamide

1-(3-hydroxypropyl)-5-[(2R)-2-[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethylamino]propyl]-2,3-dihydroindole-7-carboxamide

1-(3-hydroxypropyl)-5-[(2R)-2-[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethylamino]propyl]indoline-7-carboxamide

1-(3-oxidanylpropyl)-5-[(2R)-2-[2-[2-[2,2,2-tris(fluoranyl)ethoxy]phenoxy]ethylamino]propyl]-2,3-dihydroindole-7-carboxamide

160970-54-7

160970-64-9

1H-Indole-7-carboxamide, 2,3-dihydro-1-(3-hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-

2,3-Dihydro-1-(3-hydroxypropyl)-5-[(2R)-2-[[2-[2-(2,2,2-trifluoroethoxy)phenoxy]ethyl]amino]propyl]-1H-indole-7-carboxamide

970S649

A810210

AB0009977

ABP000202

AC-22605

AC1NSM20

AKOS005145899

AM20090780

AN-927

API0006406

BCP02143

BDBM50160154

BS-1011

C25H32F3N3O4

CCG-221202

CHEBI:135929

CHEMBL24778

CS-0284

CS0060

CUZ39LUY82

D01965

DB-064382

DB06207

DTXSID40167045

EBD33557

FT-0674584

FT-0687491

GTPL493

HMS3715B06

HY-10122

I14-33112

I14-8796

KAD 3213

KAD-3213

KAD-3213, KMD-3213

KB-60443

KMD 3213

KMD-3213

KMD3213

KSO-0400

MLS006010022

MolPort-006-167-837

PNCPYILNMDWPEY-QGZVFWFLSA-N

Q-102517

Rapaflo

Rapaflo (TN)

Rapflo

RL02066

s1613

SB19320

SC-22125

SCHEMBL136973

Silodosin (JP17/INN)

Silodosin (R-isomer)

Silodosin (Rapaflo)

Silodosin [INN:BAN]

Silodosin-d6

Silodosin, >=98% (HPLC)

Silodosin(Rapaflo)/KAD 3213,KMD 3213

Silodyx

SMR004701206

SR-01000944157

SR-01000944157-1

SW219765-1

UNII-CUZ39LUY82

Urief

Urief (TN)

Urorec

W-5225

ZINC3806063

Paragraph IV (Patent) Challenges for SILODOSIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
RAPAFLO	CAPSULE;ORAL	silodosin	022206	2012-10-09

US Patents and Regulatory Information for silodosin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	210626-002	Dec 10, 2018	AB	RX	No	No
Lupin Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	206541-001	Dec 3, 2018	AB	RX	No	No
Aurobindo Pharma Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	210626-001	Dec 10, 2018	AB	RX	No	No
Amneal Pharms Co	SILODOSIN	silodosin	CAPSULE;ORAL	209745-002	Dec 3, 2018	AB	RX	No	No
Lupin Ltd	SILODOSIN	silodosin	CAPSULE;ORAL	206541-002	Dec 3, 2018	AB	RX	No	No
Amneal Pharms Co	SILODOSIN	silodosin	CAPSULE;ORAL	209745-001	Dec 3, 2018	AB	RX	No	No

Expired US Patents for silodosin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan Sales Llc	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008
Allergan Sales Llc	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008
Allergan Sales Llc	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008
Allergan Sales Llc	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008
Allergan Sales Llc	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008
Allergan Sales Llc	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008