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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. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has six patent family members in four countries.

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

Summary for RAPAFLO

International Patents:	6
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	3
Bulk Api Vendors:	68
Clinical Trials:	7
Patent Applications:	295
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RAPAFLO
DailyMed Link:	RAPAFLO at DailyMed

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

(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

AK163125

AKOS005145899

AM20090780

AN-927

API0006406

BDBM50160154

BS-1011

C25H32F3N3O4

CCG-221202

CHEBI:135929

CHEMBL24778

CS-0284

CS0060

CUZ39LUY82

D01965

D0U0VU

DB-064382

DB06207

DTXSID40167045

EBD33557

FT-0674584

FT-0687491

GTPL493

HE070347

HY-10122

I14-33112

I14-8796

KAD 3213

KAD-3213

KAD-3213, KMD-3213

KB-60443

KMD 3213

KMD-3213

KMD3213

KSO-0400

MFCD00930170

MLS006010022

MolPort-006-167-837

PNCPYILNMDWPEY-QGZVFWFLSA-N

Q-102517

Rapaflo (TN)

Rapflo

RL02066

s1613

SC-22125

SCHEMBL136973

silodoshin

Silodosin

Silodosin (JP17/INN)

Silodosin [INN:BAN]

Silodosin-d6

Silodosin(Rapaflo)/KAD 3213,KMD 3213

Silodyx

SMR004701206

SR-01000944157

SR-01000944157-1

UNII-CUZ39LUY82

Urief

Urief (TN)

Urorec

W-5225

ZINC3806063

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			Y	Y
Allergan Sales Llc	RAPAFLO	silodosin	CAPSULE;ORAL	022206-002	Oct 8, 2008	AB	RX	Yes	No			Y	Y

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Expired US Patents for RAPAFLO

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

Paragraph IV (Patent) Challenges for RAPAFLO

Drugname	Dosage	Strength	RLD	Submissiondate
	Capsules	4 mg and 8 mg		2012-10-09

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International Patents for RAPAFLO

Country	Document Number	Estimated Expiration
Japan	2944402
Canada	2110454
Germany	122010000031
Japan	H06220015

Supplementary Protection Certificates for RAPAFLO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB10/031	United Kingdom		PRODUCT NAME: SILODOSIN, OPTIONALLY IN A FORM OF A PHARMACEUTICAL ACCEPTABLE SALT; REGISTERED: UK EU/1/09/607/001-014 20100129; UK EU/1/09/608/001-014 20100129
C0036	France		PRODUCT NAME: SILODOSIN; REGISTRATION NO/DATE IN FRANCE: EU/1/09/608/001 DU 20100129; REGISTRATION NO/DATE AT EEC: EU/1/09/608/001 DU 20100129
90028-0.L	Sweden		PRODUCT NAME: SILODOSIN ELLER FARMACEUTISKA GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/09/607/001-014 " EESGODKLANDKOD="EG" EESGODKDATUM="2010-01-29" SEGODKNR="EU/1/09/607/001-014 " SEGODKLANDKOD="EG" SEGODKDATUM="2010-01-29" FLAG="L" SPCNR="1090028-0" 20100129
00454	Netherlands		PRODUCT NAME: SILODOSIN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/09/607/001-014EU/1/09/608/001-014 2010290129