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Last Updated: July 4, 2020

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REVATIO Drug Profile


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Which patents cover Revatio, and what generic alternatives are available?

Revatio is a drug marketed by Pfizer and is included in three NDAs.

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

US ANDA Litigation and Generic Entry Outlook for Revatio

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

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Drug patent expirations by year for REVATIO
Drug Prices for REVATIO

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Recent Clinical Trials for REVATIO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ActelionPhase 1
Montefiore Medical CenterEarly Phase 1
University of Wisconsin, MadisonPhase 2

See all REVATIO clinical trials

Pharmacology for REVATIO

US Patents and Regulatory Information for REVATIO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer REVATIO sildenafil citrate FOR SUSPENSION;ORAL 203109-001 Aug 30, 2012 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer REVATIO sildenafil citrate SOLUTION;INTRAVENOUS 022473-001 Nov 18, 2009 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer REVATIO sildenafil citrate TABLET;ORAL 021845-001 Jun 3, 2005 AB RX Yes Yes   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

Supplementary Protection Certificates for REVATIO

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 300048 Netherlands   Start Trial PRODUCT NAME: ZOLMITRIPTANUM, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT OF VAN EEN SOLVAAT; NATL. REGISTRATION: RVG 21079 RVG 21080 19970925; FIRST REGISTRATION: PL 12619/0116 19970307
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Merck
McKesson
Boehringer Ingelheim
Johnson and Johnson
AstraZeneca

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