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Last Updated: April 4, 2020

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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 freedom to operate?

Sildenafil citrate is the generic ingredient in three branded drugs marketed by Pfizer, Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal Pharms, Novitium Pharma, Aurobindo Pharma Ltd, Actavis Grp Ptc, 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 thirty-one 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-four suppliers are listed for this compound. There are six tentative approvals for this compound.

Drug Prices for sildenafil citrate

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Drug Sales Revenue Trends for sildenafil citrate

See drug sales revenues for sildenafil citrate

Recent Clinical Trials for sildenafil citrate

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

SponsorPhase
Cairo UniversityPhase 1
Tongji HospitalPhase 3
University of British ColumbiaN/A

See all sildenafil citrate clinical trials

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

See all sildenafil citrate litigation

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
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
171599-83-0
2-Hydroxypropane-1,2,3-tricarboxylic acid--5-[2-ethoxy-5-(4-methylpiperazine-1-sulfonyl)phenyl]-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one (1/1)
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-methylpiperazin-1-ylsulfonyl)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-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[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
Actra-Rx
AK00601275
AKOS015856298
AKOS015951281
Apodefil
BCP02960
BCP0726000239
BW9B0ZE037
C28H38N6O11S
C55S832
CAS-171599-83-0
Caverta
CCG-213260
CHEBI:58987
CHEMBL1737
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
HIP-0908
HMS3260C20
HMS3654B08
HY-15025A
IUK-92,480
J-010743
KS-1112
LS-111685
MFCD09026931
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)
Q27126379
Revatio
Revatio (TN)
S0986
s1431
SB17346
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; Certified Reference Material
Sildenafil citrate, United States Pharmacopeia (USP) Reference Standard
sildenafil-citrate
Sildenafil, Citrate
sildenafilcitrate
SR-01000787181
SR-01000787181-2
SW199664-3
Tonafil
Tox21_111717
Tox21_111717_1
Tox21_500099
UK 92480
UK 92480-10
UK-92,480
UK-92480 citrate
UK-92480-10
UK-9248010
UNII-BW9B0ZE037
VA11751
VIAGRA
Viagra (TN)
Viagra, Sildenafil citrate
Viagra;Revatio
Wan Ai Ke
X-Excite
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
Lupin Ltd SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 212051-003 Mar 22, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Teva SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 077342-003 Mar 9, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms SILDENAFIL CITRATE sildenafil citrate FOR SUSPENSION;ORAL 211092-001 Nov 27, 2019 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 020895-003 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 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Colorcon
Moodys
Baxter
Johnson and Johnson

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.