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VIAGRA Drug Profile

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Viagra is a drug marketed by Pfizer Ireland and is included in one NDA. It is available from eleven suppliers. There is one patent protecting this drug and two Paragraph IV challenges.

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 list11

Pharmacology for Tradename: VIAGRA

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;ORAL020895-001Mar 27, 1998RXNo6,469,012*PED<disabled>Y<disabled>
Pfizer Ireland
VIAGRA
sildenafil citrate
TABLET;ORAL020895-002Mar 27, 1998RXNo6,469,012*PED<disabled>Y<disabled>
Pfizer Ireland
VIAGRA
sildenafil citrate
TABLET;ORAL020895-003Mar 27, 1998RXYes6,469,012*PED<disabled>Y<disabled>
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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;ORAL020895-001Mar 27, 19985,250,534*PED<disabled>
Pfizer Ireland
VIAGRA
sildenafil citrate
TABLET;ORAL020895-003Mar 27, 19985,250,534*PED<disabled>
Pfizer Ireland
VIAGRA
sildenafil citrate
TABLET;ORAL020895-002Mar 27, 19985,250,534*PED<disabled>
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Paragraph IV activity for: VIAGRA

Drugname Dosage Strength RLD Submissiondate
sildenafil citrateTablets25 mg and 50 mgViagra11/19/2004
sildenafil citrateTablets100 mgViagra10/25/2004

International Patent Family for Tradename: VIAGRA

Country Document Number Estimated Expiration
Norway20000703<disabled in preview>
Russian Federation2373938<disabled in preview>
Norway321622<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
C0007Belgium<disabled>PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622
1999Austria<disabled>PRODUCT NAME: ''SILDENAFIL'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, EINSCHLIESSLICH DES CITRATS; NAT. REGISTRATION NO/DATE: EU/1/98/077/001 - EU/1/98/077/012 19980914; FIRST REGISTRATION: LI 54642 01-54642 03 19980622
C/GB99/004United 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
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