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Generated: November 21, 2018

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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 silodosin freedom to operate?

Silodosin is the generic ingredient in two branded drugs marketed by Allergan Sales Llc and Sandoz Inc, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Pharmacology for silodosin
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
(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
Rapaflo (TN)
Rapflo
RL02066
s1613
SC-22125
SCHEMBL136973
silodoshin
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 silodosin

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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Sandoz Inc SILODOSIN silodosin CAPSULE;ORAL 204726-001 Mar 31, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz Inc SILODOSIN silodosin CAPSULE;ORAL 204726-002 Mar 31, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Allergan Sales Llc RAPAFLO silodosin CAPSULE;ORAL 022206-002 Oct 8, 2008 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for silodosin

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

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Supplementary Protection Certificates for silodosin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00454 Netherlands ➤ Try a Free Trial 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
C0036 France ➤ Try a Free Trial 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
C/GB10/031 United Kingdom ➤ Try a Free Trial 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
90028-0.L Sweden ➤ Try a Free Trial 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Chinese Patent Office
Merck
Daiichi Sankyo
Moodys
Fuji
Accenture
Healthtrust
Cerilliant

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.