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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Express Scripts
Healthtrust
Daiichi Sankyo
Fish and Richardson
UBS
Chinese Patent Office
Teva
Colorcon
Merck

Generated: August 21, 2017

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Sildenafil citrate - Generic Drug Details

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What are the generic sources for sildenafil citrate and what is the scope of sildenafil citrate freedom to operate?

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 Inc, 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.

Sildenafil citrate has forty-four patent family members in twenty-six countries.

There are twenty drug master file entries for sildenafil citrate. Thirty-five 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 list35
Bulk Api Vendors: see list58
Clinical Trials: see list776
Patent Applications: see list5,089
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. Strength Dosage Form
► Subscribe► Subscribe25MGTABLET; ORAL
► Subscribe► Subscribe100MGTABLET; ORAL
► Subscribe► Subscribe50MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Grp Ptc
SILDENAFIL CITRATE
sildenafil citrate
TABLET;ORAL200149-001Feb 25, 2013DISCNNoNo► Subscribe► Subscribe► Subscribe
Rubicon Res Pvt Ltd
SILDENAFIL CITRATE
sildenafil citrate
TABLET;ORAL204883-001Jun 20, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Hetero Labs Ltd V
SILDENAFIL CITRATE
sildenafil citrate
TABLET;ORAL203623-001Nov 26, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Pfizer Inc
VIAGRA
sildenafil citrate
TABLET;ORAL020895-002Mar 27, 1998RXYesNo► Subscribe► SubscribeY► Subscribe
Amneal Pharms
SILDENAFIL CITRATE
sildenafil citrate
TABLET;ORAL202025-001Feb 28, 2013ABRXNoNo► Subscribe► 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
REVATIO
sildenafil citrate
TABLET;ORAL021845-001Jun 3, 2005► Subscribe► Subscribe
Pfizer Inc
VIAGRA
sildenafil citrate
TABLET;ORAL020895-001Mar 27, 1998► Subscribe► Subscribe
Pfizer
REVATIO
sildenafil citrate
SOLUTION;INTRAVENOUS022473-001Nov 18, 2009► Subscribe► Subscribe
Pfizer Inc
VIAGRA
sildenafil citrate
TABLET;ORAL020895-003Mar 27, 1998► Subscribe► Subscribe
Pfizer Inc
VIAGRA
sildenafil citrate
TABLET;ORAL020895-002Mar 27, 1998► Subscribe► Subscribe
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International Patent Family for Ingredient: sildenafil citrate

Country Document Number Estimated Expiration
Taiwan292971► Subscribe
Norway325558► Subscribe
Czech Republic9503242► Subscribe
Japan2005097304► Subscribe
Spain2113656► 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
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
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
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
C0007Belgium► SubscribePRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Covington
Chubb
Mallinckrodt
Medtronic
Merck
Farmers Insurance
Healthtrust
Cantor Fitzgerald
US Army

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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