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RAPAFLO Drug Profile

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Rapaflo is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from three suppliers. 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 eight 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 Tradename: RAPAFLO

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list3

Pharmacology for Tradename: RAPAFLO

Clinical Trials for: RAPAFLO

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;ORAL022206-001Oct 8, 2008RXYes5,387,603<disabled>YY <disabled>
Allergan Sales Llc
RAPAFLO
silodosin
CAPSULE;ORAL022206-002Oct 8, 2008RXNo5,387,603<disabled>YY <disabled>
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Expired Patents for Tradename: RAPAFLO

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
RAPAFLO
silodosin
CAPSULE;ORAL022206-001Oct 8, 20086,015,819<disabled>
Allergan Sales Llc
RAPAFLO
silodosin
CAPSULE;ORAL022206-001Oct 8, 20085,403,847<disabled>
Allergan Sales Llc
RAPAFLO
silodosin
CAPSULE;ORAL022206-002Oct 8, 20085,780,485<disabled>
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Paragraph IV activity for: RAPAFLO

Drugname Dosage Strength RLD Submissiondate
silodosinCapsules4 mg and 8 mgRapaflo10/9/2012

International Patent Family for Tradename: RAPAFLO

Country Document Number Estimated Expiration
JapanH06220015<disabled in preview>
Japan2944402<disabled in preview>
European Patent Office0600675<disabled in preview>
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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: RAPAFLO

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
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
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
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