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RAPAFLO Drug Profile

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Which patents cover Rapaflo, and when can generic versions of Rapaflo launch?

Rapaflo is a drug marketed by Allergan Sales Llc and is included in one NDA.

The generic ingredient in RAPAFLO is silodosin. There are twelve drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the silodosin profile page.

Summary for RAPAFLO

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	74
Clinical Trials:	7
Patent Applications:	344
Drug Prices:	Drug price information for RAPAFLO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RAPAFLO
DailyMed Link:	RAPAFLO at DailyMed

See drug prices for RAPAFLO

See drug sales revenues for RAPAFLO

Recent Clinical Trials for RAPAFLO

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

Sponsor	Phase
Sir Mortimer B. Davis - Jewish General Hospital	Phase 3
Albert Einstein Healthcare Network	Phase 4
Watson Pharmaceuticals	Phase 2

See all RAPAFLO clinical trials

Recent Litigation for RAPAFLO

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 RAPAFLO litigation

Pharmacology for RAPAFLO

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

Synonyms for RAPAFLO

( 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 (TN)

Rapflo

RL02066

s1613

SB19320

SC-22125

SCHEMBL136973

Silodosin

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 RAPAFLO

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

US Patents and Regulatory Information for RAPAFLO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan Sales Llc	RAPAFLO	silodosin	CAPSULE;ORAL	022206-001	Oct 8, 2008	AB	RX	Yes	Yes
Allergan Sales Llc	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	AB	RX	Yes	No

Expired US Patents for RAPAFLO

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