➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Dow
Baxter
Colorcon
McKinsey
Merck
Boehringer Ingelheim

Last Updated: January 20, 2021

DrugPatentWatch Database Preview

SILDENAFIL CITRATE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic drug 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 Upjohn, Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal Pharms, Aptapharma Inc, Novitium Pharma, Teva Pharms Usa, Aurobindo Pharma Ltd, Actavis Grp Ptc, Amneal Pharms Ny, Apotex Corp, Appco, Hetero Labs Ltd V, Lupin Ltd, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Perrigo R And D, Reyoung, Rubicon, Sunshine, Teva, Teva Pharms, Torrent, Torrent Pharms Ltd, Umedica Labs Pvt Ltd, Watson Labs Inc, and Yiling, and is included in thirty-eight 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 four tentative approvals for this compound.

Drug Prices for SILDENAFIL CITRATE

See drug prices for SILDENAFIL CITRATE

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
The University of Texas Medical Branch, GalvestonPhase 2
Assiut UniversityPhase 4
Cairo UniversityPhase 1

See all SILDENAFIL CITRATE clinical trials

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
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
Perrigo R And D SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 205791-002 Apr 23, 2020 DISCN No No   Start Trial   Start Trial   Start Trial
Sunshine SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 213032-001 Jun 11, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Upjohn 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

Expired US Patents for SILDENAFIL CITRATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn VIAGRA sildenafil citrate TABLET;ORAL 020895-002 Mar 27, 1998   Start Trial   Start Trial
Upjohn REVATIO sildenafil citrate SOLUTION;INTRAVENOUS 022473-001 Nov 18, 2009   Start Trial   Start Trial
Upjohn VIAGRA sildenafil citrate TABLET;ORAL 020895-003 Mar 27, 1998   Start Trial   Start Trial
Upjohn 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 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 99C0007 Belgium   Start Trial PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622
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 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:

Mallinckrodt
Medtronic
Moodys
Boehringer Ingelheim
Dow
Merck

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.