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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-six 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 / Packagers: see list36
Bulk Api Vendors: see list58
Clinical Trials: see list337
Patent Applications: see list3,011
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sildenafil citrate at DailyMed

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
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd V
SILDENAFIL CITRATE
sildenafil citrate
TABLET;ORAL203623-001Nov 26, 2014RXNoNo► subscribe► subscribe
Aurobindo Pharma Ltd
SILDENAFIL CITRATE
sildenafil citrate
SOLUTION;INTRAVENOUS203988-001Apr 1, 2015RXNoNo► subscribe► subscribe
Teva Pharms
SILDENAFIL CITRATE
sildenafil citrate
TABLET;ORAL078380-001Jan 7, 2013RXNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: sildenafil citrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Ireland
VIAGRA
sildenafil citrate
TABLET;ORAL020895-002Mar 27, 19985,250,534*PED► subscribe
Pfizer
REVATIO
sildenafil citrate
TABLET;ORAL021845-001Jun 3, 20055,250,534*PED► subscribe
Pfizer
REVATIO
sildenafil citrate
SOLUTION;INTRAVENOUS022473-001Nov 18, 20095,250,534*PED► subscribe
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International Patent Family for Ingredient: sildenafil citrate

Country Document Number Estimated Expiration
Canada2163446► subscribe
Norway954757► subscribe
Norway325558► subscribe
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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
90005Netherlands► subscribePRODUCT 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
C/GB99/004United Kingdom► subscribePRODUCT 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
1999Austria► subscribePRODUCT 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
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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