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Last Updated: May 17, 2022

RAPAFLO Drug Patent Profile


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When do Rapaflo patents expire, and when can generic versions of Rapaflo launch?

Rapaflo is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in RAPAFLO is silodosin. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the silodosin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Rapaflo

A generic version of RAPAFLO was approved as silodosin by SANDOZ INC on March 31st, 2017.

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Summary for RAPAFLO
Drug patent expirations by year for RAPAFLO
Drug Prices for RAPAFLO

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Drug Sales Revenue Trends for RAPAFLO

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Recent Clinical Trials for RAPAFLO

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

SponsorPhase
Sir Mortimer B. Davis - Jewish General HospitalPhase 3
Albert Einstein Healthcare NetworkPhase 4
Watson PharmaceuticalsPhase 2

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Pharmacology for RAPAFLO
Paragraph IV (Patent) Challenges for RAPAFLO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RAPAFLO Capsules silodosin 4 mg and 8 mg 022206 3 2012-10-09

US Patents and Regulatory Information for RAPAFLO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan RAPAFLO silodosin CAPSULE;ORAL 022206-001 Oct 8, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan RAPAFLO silodosin CAPSULE;ORAL 022206-002 Oct 8, 2008 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 RAPAFLO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan RAPAFLO silodosin CAPSULE;ORAL 022206-002 Oct 8, 2008 See Plans and Pricing See Plans and Pricing
Allergan RAPAFLO silodosin CAPSULE;ORAL 022206-001 Oct 8, 2008 See Plans and Pricing See Plans and Pricing
Allergan RAPAFLO silodosin CAPSULE;ORAL 022206-002 Oct 8, 2008 See Plans and Pricing See Plans and Pricing
Allergan RAPAFLO silodosin CAPSULE;ORAL 022206-001 Oct 8, 2008 See Plans and Pricing See Plans and Pricing
Allergan RAPAFLO silodosin CAPSULE;ORAL 022206-002 Oct 8, 2008 See Plans and Pricing See Plans and Pricing
Allergan RAPAFLO silodosin CAPSULE;ORAL 022206-001 Oct 8, 2008 See Plans and Pricing See Plans and Pricing
Allergan RAPAFLO silodosin CAPSULE;ORAL 022206-002 Oct 8, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for RAPAFLO

See the table below for patents covering RAPAFLO around the world.

Country Patent Number Title Estimated Expiration
Japan 3240567 See Plans and Pricing
Israel 113248 Pharmaceutical compositions comprising alpha-ic antagonists compounds binding to alpha-ic adrenergic receptor and drugs containing them See Plans and Pricing
Israel 110902 See Plans and Pricing
Japan H06220015 INDOLINE DERIVATIVE See Plans and Pricing
Germany 122010000031 See Plans and Pricing
Canada 2148839 UTILISATION DE COMPOSES SPECIFIQUES D'ALPHA-1C POUR LE TRAITEMENT DE L'HYPERPLASIE BENIGNE DE LA PROSTATE (USE OF ALPHA-1C SPECIFIC COMPOUNDS TO TREAT BENIGN PROSTATICHYPERPLASIA) See Plans and Pricing
Germany 69319551 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for RAPAFLO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0600675 10C0036 France See Plans and Pricing 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
0600675 SPC/GB10/031 United Kingdom See Plans and Pricing 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
0600675 C300454 Netherlands See Plans and Pricing 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
0600675 1090028-0.L Sweden See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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