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Last Updated: February 24, 2020

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SILDENAFIL CITRATE Drug Profile


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When do Sildenafil Citrate patents expire, and what generic alternatives are available?

Sildenafil Citrate is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal Pharms, Novitium Pharma, Aurobindo Pharma Ltd, Actavis Grp Ptc, Amneal Pharms Ny, Apotex Corp, Hebei Changshan, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Rubicon, Teva, Teva Pharms, Torrent, Torrent Pharms Ltd, and Watson Labs Inc. and is included in twenty-seven NDAs.

The generic ingredient in SILDENAFIL CITRATE is sildenafil citrate. There are twenty drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

US ANDA Litigation and Generic Entry Outlook for Sildenafil Citrate

A generic version of SILDENAFIL CITRATE was approved as sildenafil citrate by HEBEI CHANGSHAN on November 6th, 2012.

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Drug patent expirations by year for SILDENAFIL CITRATE
Drug Prices for SILDENAFIL CITRATE

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Drug Sales Revenue Trends for SILDENAFIL CITRATE

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Recent Clinical Trials for SILDENAFIL CITRATE

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SponsorPhase
University of British ColumbiaN/A
Pia WintermarkPhase 1
Walter Reed National Military Medical CenterPhase 2

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Recent Litigation for SILDENAFIL CITRATE

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District Court Litigation
Case NameDate
Pfizer Inc. v. Umedica Laboratories Pvt., Ltd.2017-10-31
ERFINDERGEMEINSCHAFT UROPEP GbR v. Eli Lilly and Company2015-07-01
Natural Alternatives International, Inc. v. Woodbolt Distribution, LLC2011-12-21

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Pharmacology for SILDENAFIL CITRATE
Medical Subject Heading (MeSH) Categories for SILDENAFIL CITRATE
Paragraph IV (Patent) Challenges for SILDENAFIL CITRATE
Tradename Dosage Ingredient NDA Submissiondate
VIAGRA TABLET;ORAL sildenafil citrate 020895 2004-11-19
VIAGRA TABLET;ORAL sildenafil citrate 020895 2004-10-25

US Patents and Regulatory Information for SILDENAFIL CITRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Torrent SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 091448-001 Jun 11, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 201150-001 Nov 9, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs Inc SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 202503-001 Nov 6, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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