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Generated: March 18, 2019

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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, Amneal Pharms Ny, Apotex Corp, Hebei Changshan, 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 twenty-five 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-three 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
Tentative approvals for SILDENAFIL CITRATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial100MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial50MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial25MGTABLET; 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
Macleods Pharms Ltd SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 203814-001 Dec 17, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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
Actavis Grp Ptc SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 200149-001 Feb 25, 2013 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 077342-001 Mar 9, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer REVATIO sildenafil citrate FOR SUSPENSION;ORAL 203109-001 Aug 30, 2012 RX Yes Yes ➤ 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 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
Pfizer REVATIO sildenafil citrate TABLET;ORAL 021845-001 Jun 3, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer Inc VIAGRA sildenafil citrate TABLET;ORAL 020895-001 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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0463756 SPC/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
0463756 5/1999 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
0463756 99C0007 Belgium ➤ Try a Free Trial PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622
0463756 C990005 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Teva
Accenture
Express Scripts
UBS
US Army

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