You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

REVATIO Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Revatio patents expire, and when can generic versions of Revatio launch?

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

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Revatio

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

  Try a Trial

Drug patent expirations by year for REVATIO
Drug Prices for REVATIO

See drug prices for REVATIO

Recent Clinical Trials for REVATIO

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

SponsorPhase
The University of Texas Medical Branch, GalvestonPhase 2
Christoph P Hornik, MD MPHPhase 2
ActelionPhase 1

See all REVATIO clinical trials

Pharmacology for REVATIO

US Patents and Regulatory Information for REVATIO

REVATIO is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting REVATIO

LABELING REGARDING NEW DOSING REGIMEN IN ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH) AND TREATMENT OF PAH IN PEDIATRIC PATIENTS (AGES 1-17)
Exclusivity Expiration: ⤷  Try a Trial

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

International Patents for REVATIO

See the table below for patents covering REVATIO around the world.

Country Patent Number Title Estimated Expiration
Ireland 66040 Pyrazologpyrimidinone antianginal agents ⤷  Try a Trial
Hungary 211646 ⤷  Try a Trial
Taiwan 222633 ⤷  Try a Trial
Hungary 912061 ⤷  Try a Trial
Portugal 98011 PROCESSO PARA A PREPARACAO DE PIRAZOLOPIRIMIDINONAS UTEIS COMO AGENTES ANTIANGINOSOS ⤷  Try a Trial
Finland 913017 ⤷  Try a Trial
Poland 166490 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for REVATIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0463756 99C0007 Belgium ⤷  Try a Trial PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622
0463756 SPC/GB99/004 United Kingdom ⤷  Try a 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 ⤷  Try a 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 ⤷  Try a 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 300048 Netherlands ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.