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Silodosin - Generic Drug Details

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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 eight drug master file entries for silodosin. Three suppliers are listed for this compound.

Summary for Generic Name: silodosin

Tradenames:1
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list8
Suppliers / Packaging: see list3

Pharmacology for Ingredient: silodosin

Clinical Trials for: silodosin

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Sales Llc
RAPAFLO
silodosin
CAPSULE;ORAL022206-002Oct 8, 2008RXNo5,387,603<disabled>YY <disabled>
Allergan Sales Llc
RAPAFLO
silodosin
CAPSULE;ORAL022206-001Oct 8, 2008RXYes5,387,603<disabled>YY <disabled>
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Expired Orange Book Patents for Generic Ingredient: silodosin

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

Country Document Number Estimated Expiration
Germany122010000031<disabled in preview>
JapanH06220015<disabled in preview>
Japan2944402<disabled in preview>
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Supplementary Protection Certificates for Tradename: SILODOSIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90028-0.LSweden<disabled>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
C0036France<disabled>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/GB10/031United Kingdom<disabled>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
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