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Last Updated: April 5, 2020

DrugPatentWatch Database Preview

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-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 Revatio

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

  Start Trial

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

Recent Litigation for REVATIO

Identify potential future generic entrants

District Court Litigation
Case NameDate
Natural Alternatives International, Inc. v. Woodbolt Distribution, LLC2011-12-21
PFIZER INC. v. HETERO DRUGS LTD.2011-07-28
Pfizer Inc. v. Watson Pharmaceuticals, Inc.2011-06-01

See all REVATIO litigation

Pharmacology for REVATIO
Synonyms for REVATIO
1-((3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-4-ethoxyphenyl)sulfonyl)-4-methylpiperazine
1-((3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-4-ethoxyphenyl)sulfonyl)-4-methylpiperazine citrate
139755-83-2
1udt
1xos
2h42
3M7OB98Y7H
4-((4-Ethoxy-3-(1-methyl-7-oxo-3-propyl-6,7-dihydr
5-(2-ethoxy-5-((4-methylpiperazin-1-yl)sulfonyl)phenyl)-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one
5-(2-Ethoxy-5-((4-methylpiperazin-1-yl)sulfonyl)phenyl)-1-methyl-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-7(6H)-one
5-[2-ethoxy-5-(4-methyl-1-piperazinylsulfonyl)phenyl]-1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one
5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonyl-phenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidin-7-one
5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonylphenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidin-7-one
5-[2-Ethoxy-5-(4-methylpiperazin-1-ylsulfonyl)phenyl]-1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one
5-[2-Ethoxy-5-(4-methylpiperazin-1-ylsulfonyl)phenyl]-1-methyl-3-n-propyl-1.6-dihydro-7H-pyrazolo[4,3-d]Pyrimidin-7-one
5-[2-ethoxy-5-(4-methylpiperazine-1-sulfonyl)phenyl]-1-methyl-3-propyl-1H,4H,7H-pyrazolo[4,3-d]pyrimidin-7-one
5-[2-ethoxy-5-(4-methylpiperazinylsulfonyl)phenyl]-1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo(4,3-d]pyrimidin-7-one
5-[2-ethoxy-5-(4-methylpiperazinylsulfonyl)phenyl]-1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one
5-{2-(ethyloxy)-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one
5-{2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1,4-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one
5-{2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one
5-{2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-7-ol
5-{2-ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl}-1-methyl-3-propyl-1H,4H,7H-pyrazolo[4,3-d]pyrimidin-7-one
5-{2-ETHOXY-5-[(4-METHYLPIPERAZIN-1-YL)SULFONYL]PHENYL}-1-METHYL-3-PROPYL-1H,6H,7H-PYRAZOLO[4,3-D]PYRIMIDIN-7-ONE
5-{2-ethoxy-5-[(4-methylpiperazine-1-)sulfonyl]phenyl}-1-methyl-3-propyl-1H,6H,7H-pyrazolo[4,3-d]pyrimidin-7-one
755S832
AB00052444_04
AB00052444_05
AB00052444-02
AB00052444-03
AB0015440
AC-938
ACT02662
AKOS008901403
AKOS025397193
Aphrodil (TN)
AS-48884
BCP05337
BDBM14390
BIDD:GT0352
BNRNXUUZRGQAQC-UHFFFAOYSA-N
BRD-K50128260-001-01-6
BRD-K79759585-001-02-1
BRD-K79759585-048-01-4
BSPBio_003424
C07259
C22H30N6O4S
Cambridge id 7030299
CCG-21806
CCG-39076
CHEBI:9139
CHEMBL192
CS-1577
D08514
DB00203
DivK1c_006894
DTXSID6023579
FT-0601554
GTPL4743
HIP-0908
HIP0908
HMS1684K08
HMS1922B19
HMS2089M12
HMS2093O17
HMS2233L22
HMS3372N07
HMS3715P17
HMS3740G19
HSDB 7305
HY-15025
J-007309
KBio1_001838
KBio2_002035
KBio2_004603
KBio2_007171
KBio3_002927
KBioGR_001052
KBioSS_002035
KS-00000XMX
LS-111655
M901
MCULE-2481702478
MLS001240224
MLS001304737
MLS006011565
NCGC00095099-01
NCGC00095099-02
NCGC00095099-03
NCGC00095099-04
NCGC00159496-02
NCGC00370976-03
NCX-911
Piperazine, 1-((3-(4,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-4-ethoxyphenyl)sulfonyl)-4-methyl-
Q191521
s4684
SB17345
SBI-0051920.P002
SC-83326
SCHEMBL1895
SCHEMBL5795456
SCHEMBL8100377
sildenafil
Sildenafil (INN)
Sildenafil [INN:BAN]
Sildenafil 1.0 mg/ml in Methanol
Sildenafil solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
SILDENAFIL; VIAGRA
Sildenafil#
SMR000752512
SMR004703325
SPBio_001775
SpecPlus_000798
Spectrum_001555
SPECTRUM1504099
Spectrum2_001648
Spectrum3_001892
Spectrum4_000586
Spectrum5_001508
SR-01000504734
SR-01000504734-1
SR-05000001934
SR-05000001934-1
SR-05000001934-2
STL483201
STL483720
STL565123
UK 92480-10
UK-92,480-10
UK-92480
UNII-3M7OB98Y7H
VIAGRA
Vizarsin
W-2194
Z1522567175
ZINC19796168

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 99C0007 Belgium   Start 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   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 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 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 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
>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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