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. Fourteen 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.
Summary for RAPAFLO
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 7 |
Patent Applications: | 478 |
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 |
Pharmacology for RAPAFLO
Drug Class | alpha-Adrenergic Blocker |
Mechanism of Action | Adrenergic alpha-Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for RAPAFLO
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 | 022206-001 | 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 |
>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 |
---|---|---|---|
Australia | 2240495 | ⤷ Try a Trial | |
Germany | 122010000031 | ⤷ Try a Trial | |
Israel | 113248 | Pharmaceutical compositions comprising alpha-ic antagonists compounds binding to alpha-ic adrenergic receptor and drugs containing them | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 9619662 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 9528157 | ⤷ 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 | 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 |
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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |