Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

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 Pfizer, Novitium Pharma, Aurobindo Pharma Ltd, Actavis Grp Ptc, Ajanta Pharma Ltd, Amneal Pharms, 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, Watson Labs Inc, and Pfizer Inc, and is included in twenty-eight 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-five patent family members in twenty-six countries.

There are twenty drug master file entries for sildenafil citrate. Forty-seven suppliers are listed for this compound. There are seven tentative approvals for this compound.

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
Walter Reed National Military Medical CenterPhase 2
Uniformed Services University of the Health SciencesPhase 2
Cairo UniversityN/A

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Recent Litigation for SILDENAFIL CITRATE

Identify potential future generic entrants

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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Generic filers with tentative approvals for SILDENAFIL CITRATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial100MGTABLET; ORAL
  Start Trial  Start Trial50MGTABLET; ORAL
  Start Trial  Start Trial25MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Mylan Pharms Inc SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 201150-001 Nov 9, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Rubicon SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 204882-002 Jun 11, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 212051-003 Mar 22, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd V SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 203623-001 Nov 26, 2014 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

Expired US Patents for SILDENAFIL CITRATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer REVATIO sildenafil citrate SOLUTION;INTRAVENOUS 022473-001 Nov 18, 2009   Start Trial   Start Trial
Pfizer Inc VIAGRA sildenafil citrate TABLET;ORAL 020895-002 Mar 27, 1998   Start Trial   Start Trial
Pfizer Inc VIAGRA sildenafil citrate TABLET;ORAL 020895-001 Mar 27, 1998   Start Trial   Start Trial
Pfizer REVATIO sildenafil citrate TABLET;ORAL 021845-001 Jun 3, 2005   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for SILDENAFIL CITRATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0463756 SPC/GB99/004 United Kingdom   Start Trial 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
0463756 5/1999 Austria   Start Trial PRODUCT 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
0463756 C990005 Netherlands   Start Trial 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
0463756 99C0007 Belgium   Start Trial PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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