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Silodosin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for silodosin?

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

This ingredient has six patent family members in four countries.

There are ten drug master file entries for silodosin. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: silodosin

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list10
Suppliers / Packagers: see list3
Bulk Api Vendors: see list55
Clinical Trials: see list11
Patent Applications: see list256
Drug Prices:see low prices
DailyMed Link:silodosin at DailyMed

Pharmacology for Ingredient: silodosin

Tentative approvals for SILODOSIN

Applicant Application No. Form Dosage
► Subscribe► SubscribeCAPSULE;ORAL4MG
► Subscribe► SubscribeCAPSULE;ORAL8MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Sales Llc
RAPAFLO
silodosin
CAPSULE;ORAL022206-001Oct 8, 2008RXYesYes5,387,603► SubscribeYY ► Subscribe
Allergan Sales Llc
RAPAFLO
silodosin
CAPSULE;ORAL022206-002Oct 8, 2008RXYesNo5,387,603► SubscribeYY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: silodosin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
RAPAFLO
silodosin
CAPSULE;ORAL022206-002Oct 8, 20086,015,819► Subscribe
Allergan Sales Llc
RAPAFLO
silodosin
CAPSULE;ORAL022206-001Oct 8, 20085,403,847► Subscribe
Allergan Sales Llc
RAPAFLO
silodosin
CAPSULE;ORAL022206-002Oct 8, 20085,403,847► Subscribe
Allergan Sales Llc
RAPAFLO
silodosin
CAPSULE;ORAL022206-002Oct 8, 20085,760,485► Subscribe
Allergan Sales Llc
RAPAFLO
silodosin
CAPSULE;ORAL022206-002Oct 8, 20085,780,485► Subscribe
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International Patent Family for Ingredient: silodosin

Country Document Number Estimated Expiration
JapanH06220015► Subscribe
Germany69319551► Subscribe
Japan2944402► Subscribe
Canada2110454► Subscribe
European Patent Office0600675► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: SILODOSIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00454Netherlands► SubscribePRODUCT 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
C/GB10/031United Kingdom► SubscribePRODUCT 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.LSweden► SubscribePRODUCT 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
C0036France► SubscribePRODUCT 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
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