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Generated: May 27, 2018

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Sildenafil citrate - Generic Drug Details

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What are the generic sources for sildenafil citrate and what is the scope of sildenafil citrate freedom to operate?

Sildenafil citrate
is the generic ingredient in three branded drugs marketed by Pfizer, Aurobindo Pharma Ltd, Actavis Grp Ptc, Ajanta Pharma Ltd, Amneal Pharms, Apotex Corp, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan Pharms Inc, Rubicon Res Pvt Ltd, Teva, Teva Pharms, Torrent Pharms Ltd, Watson Labs Inc, and Pfizer Inc, and is included in nineteen 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. Thirty-nine suppliers are listed for this compound. There are eleven tentative approvals for this compound.
Pharmacology for sildenafil citrate
Medical Subject Heading (MeSH) Categories for sildenafil citrate
Synonyms for sildenafil citrate
1-((3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-4-ethoxyphenyl)sulfonyl)-4-methyl-,2-hydroxy-1,2,3-propanetricarboxylate
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
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 (1:1)
1-[[3-(4,7-dihydro-1-methyl-7-oxo-3-propyl-1h-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate
1-[[3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate salt
1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1-h-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate
1-{[3-(6,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl}-4-methylpiperazone citrate
139755-83-2 (Parent)
171599-83-0
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 2-hydroxypropane-1,2,3-tricarboxylate
5-(2-ethoxy-5-((4-methylpiperazin-1-yl)sulfonyl)phenyl)-1-methyl-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-7(6H)-one 2-hydroxypropane-1,2,3-tricarboxylate
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 citrate
5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonyl-phenyl]-1-methyl-3-propyl-4H-pyrazolo[4,3-d]pyrimidin-7-one; 2-oxidanylpropane-1,2,3-tricarboxylic acid
5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonylphenyl]-1-methyl-3-propyl-4H-pyrazolo[4,3-d]pyrimidin-7-one; 2-hydroxypropane-1,2,3-tricarboxylic acid
5-[2-Ethoxy-5-(4-methylpiperazin-1-yl)sulfonylphenyl]-1-methyl-3-propyl-4H-pyrazolo[5,4-e]pyrimidin-7-one citrate salt
5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonylphenyl]-1-methyl-3-propyl-6H-pyrazolo[4,3-d]pyrimidin-7-one;2-hydroxypropane-1,2,3-tricarboxylic acid
5-[2-Ethoxy-5-(4-methylpiperazin-1-ylsulfonyl)phenyl]-1,3-d]pyrimidin-7-one-citrate
5-[2-ethoxy-5-[(4-methyl-1-piperazinyl)sulfonyl]phenyl]-1-methyl-3-propyl-4H-pyrazolo[4,3-d]pyrimidin-7-one; 2-hydroxypropane-1,2,3-tricarboxylic acid
5-[2-Ethoxy-5-[(4-methyl-1-piperazinyl)sulfonyl]phenyl]-1,6-dihydro-1-methyl-3-propyl-7H-pyrazolo[4,3-d]pyrimidin-7-one 2-hydroxy-1,2,3-propanetricarboxylate
5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-7(6H)-one Citrate
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 2-hydroxypropane-1,2,3-tricarboxylate
A807582
A811336
AB0089286
AB1009362
AB2000102
AC-1310
AC1L1XX1
Actra-Rx
AKOS015856298
AKOS015951281
AN-15068
Apodefil
BC666107
BCP0726000239
BW9B0ZE037
C28H38N6O11S
C55S832
CAS-171599-83-0
Caverta
CCG-213260
CHEBI:58987
CHEMBL1737
citric acid; 5-[2-ethoxy-5-(4-methylpiperazin-1-yl)sulfonyl-phenyl]-1-methyl-3-propyl-4H-pyrazolo[4,3-d]pyrimidin-7-one
citro; sildenafil
CS-1576
D02229
DEIYFTQMQPDXOT-UHFFFAOYSA-N
DSSTox_CID_26076
DSSTox_GSID_46076
DSSTox_RID_81321
DTXSID4046076
Duromist
Edegra
F0001-2406
FT-0082439
FT-0601540
GHL-901
HE072803
HIP-0908
HMS3260C20
HMS3654B08
HY-15025A
I06-1874
IUK-92,480
J-010743
Jsp003501
KS-1112
LS-111685
MFCD09026931
MolPort-003-850-246
MolPort-006-069-375
MolPort-006-823-012
NCGC00095099-05
NCGC00159496-02
NCGC00260784-01
NSC-744009
NSC-758669
NSC744009
NSC758669
NVD-401
Patrex
Penegra
Pharmakon1600-01504099
Piperazine, 1-((3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo(4,3-d)pyrimidin-5-yl)-4-ethoxyphenyl)sulfonyl)-4-methyl-, 2-hydroxy-1,2,3-propanetricarboxylate (1:1)
Revatio
Revatio (TN)
S0986
s1431
SC-44588
SCHEMBL33982
Sildenafil (citrate)
Sildenafil citrate (JAN/USAN)
Sildenafil citrate [USAN]
Sildenafil citrate salt
Sildenafil citrate salt, >=98% (HPLC)
Sildenafil citrate salt, European Pharmacopoeia (EP) Reference Standard
Sildenafil citrate, European Pharmacopoeia (EP) Reference Standard
Sildenafil Citrate, pharmaceutical secondary standard; traceable to USP, PhEur
Sildenafil citrate, United States Pharmacopeia (USP) Reference Standard
Sildenafil, Citrate
sildenafilcitrate
Tonafil
Tox21_111717
Tox21_111717_1
Tox21_500099
UK 92480
UK 92480-10
UK-92,480
UK-92480-10
UK-9248010
UNII-BW9B0ZE037
VA11751
VIAGRA
Viagra (TN)
Viagra, Sildenafil citrate
Viagra;Revatio
Wan Ai Ke
X-Excite
Tentative approvals for SILDENAFIL CITRATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial25MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial100MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial50MGTABLET; ORAL

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
Pfizer Inc VIAGRA sildenafil citrate TABLET;ORAL 020895-003 Mar 27, 1998 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Watson Labs Inc SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 202503-001 Nov 6, 2012 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 077342-002 Mar 9, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Aurobindo Pharma Ltd SILDENAFIL CITRATE sildenafil citrate SOLUTION;INTRAVENOUS 203988-001 Apr 1, 2015 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Expired US Patents for sildenafil citrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Inc VIAGRA sildenafil citrate TABLET;ORAL 020895-001 Mar 27, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer REVATIO sildenafil citrate SOLUTION;INTRAVENOUS 022473-001 Nov 18, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Inc VIAGRA sildenafil citrate TABLET;ORAL 020895-003 Mar 27, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Inc VIAGRA sildenafil citrate TABLET;ORAL 020895-002 Mar 27, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for sildenafil citrate

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90005 Netherlands ➤ Try a Free 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
C0007 Belgium ➤ Try a Free Trial PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622
C/GB99/004 United Kingdom ➤ Try a Free 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
1999 Austria ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Covington
Healthtrust
Cerilliant
Fish and Richardson
Chubb
AstraZeneca
Julphar
Merck

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