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Last Updated: March 28, 2024

RAPAFLO Drug Patent Profile


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Which patents cover Rapaflo, and what generic alternatives are available?

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. Thirteen 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 on March 31st, 2017.

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

See drug prices for RAPAFLO

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

See all RAPAFLO clinical trials

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Allergan RAPAFLO silodosin CAPSULE;ORAL 022206-002 Oct 8, 2008 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 RAPAFLO

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

EU/EMA Drug Approvals for RAPAFLO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Recordati Ireland Ltd Urorec silodosin EMEA/H/C/001092
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).
Authorised no no no 2010-01-29
Recordati Ireland Ltd Silodosin Recordati silodosin EMEA/H/C/004964
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men.
Authorised yes no no 2019-01-07
Recordati Ireland Ltd Silodyx silodosin EMEA/H/C/001209
Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH)
Authorised no no no 2010-01-29
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for RAPAFLO

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

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 9528157 ⤷  Try a Trial
Japan H08506800 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9410989 ⤷  Try a Trial
European Patent Office 0758894 ⤷  Try a Trial
Israel 110902 ⤷  Try a Trial
European Patent Office 0600675 Composés indoliniques pour le traitement de la dysurien (Indoline compounds for the treatment of dysuria) ⤷  Try a Trial
Australia 1280195 ⤷  Try a Trial
>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 ⤷  Try a Trial 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 1090028-0.L Sweden ⤷  Try a Trial 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
0600675 SPC/GB10/031 United Kingdom ⤷  Try a Trial 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 ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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