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VIAGRA Drug Profile
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This drug has forty-four patent family members in twenty-six countries.
The generic ingredient in VIAGRA is sildenafil citrate. There are twenty drug master file entries for this compound. Thirty-two suppliers are listed for this compound. There are eleven tentative approvals for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for Tradename: VIAGRA
| Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 11 |
| Drug Prices: : | see details |
Pharmacology for Tradename: VIAGRA
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Clinical Trials for: VIAGRA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer Ireland | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-001 | Mar 27, 1998 | RX | No | 6,469,012*PED | Apr 22, 2020 | Y | |||||||||||||||||||
Pfizer Ireland | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-002 | Mar 27, 1998 | RX | No | 6,469,012*PED | Apr 22, 2020 | Y | |||||||||||||||||||
Pfizer Ireland | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-003 | Mar 27, 1998 | RX | Yes | 6,469,012*PED | Apr 22, 2020 | Y | |||||||||||||||||||
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Expired Patents for Tradename: VIAGRA
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer Ireland | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-001 | Mar 27, 1998 | 5,250,534*PED | <disabled> | ||||||||||||||||||||||
Pfizer Ireland | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-003 | Mar 27, 1998 | 5,250,534*PED | <disabled> | ||||||||||||||||||||||
Pfizer Ireland | VIAGRA | sildenafil citrate | TABLET;ORAL | 020895-002 | Mar 27, 1998 | 5,250,534*PED | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: VIAGRA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| sildenafil citrate | Tablets | 25 mg and 50 mg | Viagra | 11/19/2004 |
| sildenafil citrate | Tablets | 100 mg | Viagra | 10/25/2004 |
International Patent Family for Tradename: VIAGRA
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hungary | 9501933 | <disabled in preview> | |||||||||||||||||||||||||||
| Cyprus | 2099 | <disabled in preview> | |||||||||||||||||||||||||||
| China | 1124926 | <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: VIAGRA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB99/004 | United Kingdom | <disabled> | PRODUCT NAME: SILDENAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE CITRATE SALT; REGISTERED: CH 54642 19980622; UK EU/1/98/077/001 19980914; UK EU/1/98/077/002 19980914; UK EU/1/98/077/003 19980914; UK EU/1/98/077/004 19980914; UK EU/1/98/077/005 19980914; UK EU/1/98/077/006 19980914; UK EU/1/98/077/007 19980914; UK EU/1/98/077/008 19980914; UK EU/1/98/077/009 19980914; UK EU/1/98/077/010 19980914; UK EU/1/98/077/011 19980914; UK EU/1/98/077/012 19980914 | ||||||||||||||||||||||||||
| 90005 | Netherlands | <disabled> | PRODUCT NAME: SILDENAFIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SILDENAFIL CITRAAT; NATL REGISTRATION NO/DATE: EU/1/98/077/001-012 19980914; FIRST REGISTRATION: CH 54642 19980622 | ||||||||||||||||||||||||||
| C0007 | Belgium | <disabled> | PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622 | ||||||||||||||||||||||||||
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