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RAPAFLO Drug Profile
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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. There is one tentative approval 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 list | 3 |
| Drug Prices: : | see details |
Pharmacology for Tradename: RAPAFLO
| Drug Class | alpha-Adrenergic Blocker |
| Mechanism of Action | Adrenergic alpha-Antagonists |
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;ORAL | 022206-001 | Oct 8, 2008 | RX | Yes | 5,387,603 | Dec 1, 2018 | Y | Y | ||||||||||||||||||
Allergan Sales Llc | RAPAFLO | silodosin | CAPSULE;ORAL | 022206-002 | Oct 8, 2008 | RX | No | 5,387,603 | Dec 1, 2018 | Y | Y | ||||||||||||||||||
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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;ORAL | 022206-001 | Oct 8, 2008 | 5,403,847 | <disabled> | ||||||||||||||||||||||
Allergan Sales Llc | RAPAFLO | silodosin | CAPSULE;ORAL | 022206-002 | Oct 8, 2008 | 6,015,819 | <disabled> | ||||||||||||||||||||||
Allergan Sales Llc | RAPAFLO | silodosin | CAPSULE;ORAL | 022206-002 | Oct 8, 2008 | 5,780,485 | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: RAPAFLO
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| silodosin | Capsules | 4 mg and 8 mg | Rapaflo | 10/9/2012 |
International Patent Family for Tradename: RAPAFLO
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 0600675 | <disabled in preview> | |||||||||||||||||||||||||||
| Japan | 2944402 | <disabled in preview> | |||||||||||||||||||||||||||
| Germany | 69319551 | <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.L | Sweden | <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 | ||||||||||||||||||||||||||
| 00454 | Netherlands | <disabled> | 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 | ||||||||||||||||||||||||||
| C/GB10/031 | United 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 | ||||||||||||||||||||||||||
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