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Generated: April 29, 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 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 Ireland, and Dr Reddys Labs Ltd, and is included in eighteen NDAs. There are two patents 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-seven 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 / Packagers: see list37
Bulk Api Vendors: see list58
Clinical Trials: see list337
Patent Applications: see list4,898
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
► Subscribe► SubscribeTABLET; ORAL25MG
► Subscribe► SubscribeTABLET; ORAL50MG
► Subscribe► SubscribeTABLET; ORAL100MG
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hetero Labs Ltd V
sildenafil citrate
TABLET;ORAL203623-001Nov 26, 2014ABRXNoNo► Subscribe► Subscribe
sildenafil citrate
SOLUTION;INTRAVENOUS022473-001Nov 18, 2009APRXYesYes► Subscribe► Subscribe
Aurobindo Pharma Ltd
sildenafil citrate
SOLUTION;INTRAVENOUS203988-001Apr 1, 2015APRXNoNo► Subscribe► Subscribe
Dr Reddys Labs Ltd
sildenafil citrate
TABLET;ORAL202598-001Nov 6, 2012ABRXNoNo► Subscribe► Subscribe
sildenafil citrate
FOR SUSPENSION;ORAL203109-001Aug 30, 2012RXYesYes► Subscribe► Subscribe
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