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Details for Generic Name: sildenafil citrate

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

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

Summary for Generic Name: sildenafil citrate

Drug Master File Entries: see list20
Suppliers / Packaging: see list75
Therapeutic Class:Respiratory Tract Agents

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

A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions
Status: Completed Condition: Pulmonary Arterial Hypertention

Sildenafil for Prevention of Cerebral Vasospasm
Status: Withdrawn Condition: Subarachnoid Hemorrhage; Cerebral Vasospasm; Rupture of Intracranial Aneurysm

A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies
Status: Not yet recruiting Condition: Erectile Dysfunction

Viagra in the Treatment of Primary Dysmenorrhea
Status: Completed Condition: Dysmenorrhea

Study of Regorafenib and Sildenafil for Advanced Solid Tumors
Status: Recruiting Condition: Solid Tumor

Does Oral Sildenafil (Viagra) Decrease Mean Pulmonary Artery Pressure After Cardiac Surgery?
Status: Completed Condition: Pulmonary Hypertension

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
sildenafil citrate
TABLET;ORAL021845-001Jun 3, 2005RXYes<disabled><disabled>
Aurobindo Pharma Ltd
sildenafil citrate
TABLET;ORAL203963-001Nov 18, 2015RXNo<disabled><disabled>
Actavis Grp Ptc
sildenafil citrate
TABLET;ORAL200149-001Feb 25, 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
sildenafil citrate
SOLUTION;INTRAVENOUS022473-001Nov 18, 20095,250,534*PED<disabled>
Pfizer Ireland
sildenafil citrate
TABLET;ORAL020895-003Mar 27, 19985,250,534*PED<disabled>
sildenafil citrate
TABLET;ORAL021845-001Jun 3, 20055,250,534*PED<disabled>
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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.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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