Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Boehringer Ingelheim

Last Updated: December 16, 2019

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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.

Drug Prices for silodosin

See drug prices for silodosin

Recent Clinical Trials for silodosin

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

SponsorPhase
Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshPhase 4
Sir Mortimer B. Davis - Jewish General HospitalPhase 3
Centre Hospitalier Departemental VendeePhase 3

See all silodosin clinical trials

Recent Litigation for silodosin

Identify potential future generic entrants

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

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

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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.