.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Sildenafil citrate - Generic Drug Details

« Back to Dashboard
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
Drug Prices:see low prices

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
Macleods Pharms Ltd
SILDENAFIL CITRATE
sildenafil citrate
TABLET;ORAL203814-001Dec 17, 2013RXNo
Mylan Pharms Inc
SILDENAFIL CITRATE
sildenafil citrate
TABLET;ORAL201150-001Nov 9, 2012RXNo
Pfizer
REVATIO
sildenafil citrate
TABLET;ORAL021845-001Jun 3, 2005RXYesAug 30, 2015
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: sildenafil citrate

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

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<disabled>
Pfizer
REVATIO
sildenafil citrate
TABLET;ORAL021845-001Jun 3, 20055,250,534*PED<disabled>
Pfizer Ireland
VIAGRA
sildenafil citrate
TABLET;ORAL020895-003Mar 27, 19985,250,534*PED<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: sildenafil citrate

Country Document Number Estimated Expiration
Poland311948<disabled in preview>
Norway954757<disabled in preview>
EcuadorSP941102<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: SILDENAFIL CITRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
90005Netherlands<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
C0007Belgium<disabled>PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc