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Sildenafil citrate - Generic Drug Details

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Sildenafil citrate is the generic ingredient in three branded drugs marketed by Watson Labs Inc, Pfizer, Macleods Pharms Ltd, Hetero Labs Ltd V, Amneal Pharms, Teva, Actavis Grp Ptc, Mylan Pharms Inc, Aurobindo Pharma Ltd, Apotex Corp, Torrent Pharms Ltd, Teva Pharms, Rubicon Res Pvt Ltd, Pfizer Ireland, and Dr Reddys Labs Ltd, and is included in eighteen NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-four patent family members in twenty-six countries.

There are twenty drug master file entries for sildenafil citrate. Thirty-two suppliers are listed for this compound. There are eleven tentative approvals for this compound.

Summary for Generic Name: sildenafil citrate

Tradenames:3
Patents:1
Applicants:15
NDAs:18
Drug Master File Entries: see list20
Suppliers / Packaging: see list32
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: sildenafil citrate

Tentative approvals for SILDENAFIL CITRATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL25MG
<disabled><disabled>TABLET; ORAL50MG
<disabled><disabled>TABLET; ORAL100MG

Clinical Trials for: sildenafil citrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer
REVATIO
sildenafil citrate
FOR SUSPENSION;ORAL203109-001Aug 30, 2012RXYes<disabled><disabled>
Pfizer
REVATIO
sildenafil citrate
TABLET;ORAL021845-001Jun 3, 2005RXYes<disabled><disabled>
Amneal Pharms
SILDENAFIL CITRATE
sildenafil citrate
TABLET;ORAL202025-001Feb 28, 2013RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: sildenafil citrate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
REVATIO
sildenafil citrate
SOLUTION;INTRAVENOUS022473-001Nov 18, 20095,250,534*PED<disabled>
Pfizer Ireland
VIAGRA
sildenafil citrate
TABLET;ORAL020895-002Mar 27, 19985,250,534*PED<disabled>
Pfizer Ireland
VIAGRA
sildenafil citrate
TABLET;ORAL020895-003Mar 27, 19985,250,534*PED<disabled>
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International Patent Family for Ingredient: sildenafil citrate

Country Document Number Estimated Expiration
Norway309227<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: SILDENAFIL CITRATE

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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