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 Abbvie 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 CHARTWELL RX on March 31st, 2017.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for RAPAFLO?
- What are the global sales for RAPAFLO?
- What is Average Wholesale Price for RAPAFLO?
Summary for RAPAFLO
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 99 |
| Clinical Trials: | 7 |
| Patent Applications: | 1,011 |
| Drug Prices: | Drug price information for RAPAFLO |
| What excipients (inactive ingredients) are in RAPAFLO? | RAPAFLO excipients list |
| DailyMed Link: | RAPAFLO at DailyMed |
Recent Clinical Trials for RAPAFLO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sir Mortimer B. Davis - Jewish General Hospital | Phase 3 |
| Albert Einstein Healthcare Network | Phase 4 |
| Watson Pharmaceuticals | Phase 2 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbvie | RAPAFLO | silodosin | CAPSULE;ORAL | 022206-001 | Oct 8, 2008 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Abbvie | RAPAFLO | silodosin | CAPSULE;ORAL | 022206-002 | Oct 8, 2008 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 |
|---|---|---|---|---|---|---|---|
| Abbvie | RAPAFLO | silodosin | CAPSULE;ORAL | 022206-002 | Oct 8, 2008 | 5,760,485 | ⤷ Start Trial |
| Abbvie | RAPAFLO | silodosin | CAPSULE;ORAL | 022206-002 | Oct 8, 2008 | 5,780,485 | ⤷ Start Trial |
| Abbvie | RAPAFLO | silodosin | CAPSULE;ORAL | 022206-001 | Oct 8, 2008 | 5,387,603 | ⤷ Start Trial |
| Abbvie | RAPAFLO | silodosin | CAPSULE;ORAL | 022206-002 | Oct 8, 2008 | 6,015,819 | ⤷ Start 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/001092Treatment 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/004964Treatment 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/001209Treatment 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 |
|---|---|---|---|
| Canada | 2110454 | COMPOSES DE L'INDOLINE 1,5,7-TRISUBSTITUES POUR LE TRAITEMENT DE LA DYSURIE (1,5,7-TRISUBSTITUTED INDOLINE COMPOUNDS FOR THE TREATMENT OFDYSURIA) | ⤷ Start Trial |
| Germany | 122010000031 | ⤷ Start Trial | |
| Germany | 69319551 | ⤷ Start Trial | |
| European Patent Office | 0600675 | Composés indoliniques pour le traitement de la dysurien (Indoline compounds for the treatment of dysuria) | ⤷ Start Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RAPAFLO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0600675 | C300454 | Netherlands | ⤷ Start 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 |
| 0600675 | 1090028-0.L | Sweden | ⤷ Start 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 | 10C0036 | France | ⤷ Start 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 | SPC/GB10/031 | United Kingdom | ⤷ Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
DrugChatter Q&A for RAPAFLO
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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