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Serving leading biopharmaceutical companies globally:

Harvard Business School
Mallinckrodt
Teva
Covington
US Army
AstraZeneca
Boehringer Ingelheim
Medtronic
Julphar
Accenture

Generated: January 19, 2018

DrugPatentWatch Database Preview

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, 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 eighteen 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-seven suppliers are listed for this compound. There are eleven tentative approvals for this compound.
Summary for sildenafil citrate
Pharmacology for sildenafil citrate
Medical Subject Heading (MeSH) Categories for sildenafil citrate
Tentative approvals for SILDENAFIL CITRATE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe25MGTABLET; ORAL
➤ Subscribe➤ Subscribe100MGTABLET; ORAL
➤ Subscribe➤ Subscribe50MGTABLET; 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
Watson Labs Inc SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 202503-001 Nov 6, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Hetero Labs Ltd V SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 203623-001 Nov 26, 2014 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pfizer REVATIO sildenafil citrate TABLET;ORAL 021845-001 Jun 3, 2005 AB RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Macleods Pharms Ltd SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 203814-001 Dec 17, 2013 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Aurobindo Pharma Ltd SILDENAFIL CITRATE sildenafil citrate SOLUTION;INTRAVENOUS 203988-001 Apr 1, 2015 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Actavis Grp Ptc SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 200149-001 Feb 25, 2013 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Torrent Pharms Ltd SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 091479-001 Nov 6, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Dr Reddys Labs Ltd SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 202598-001 Nov 6, 2012 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 077342-002 Mar 9, 2016 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Teva SILDENAFIL CITRATE sildenafil citrate TABLET;ORAL 077342-003 Mar 9, 2016 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe ➤ Subscribe
Pfizer REVATIO sildenafil citrate SOLUTION;INTRAVENOUS 022473-001 Nov 18, 2009 ➤ Subscribe ➤ Subscribe
Pfizer Inc VIAGRA sildenafil citrate TABLET;ORAL 020895-002 Mar 27, 1998 ➤ Subscribe ➤ Subscribe
Pfizer REVATIO sildenafil citrate TABLET;ORAL 021845-001 Jun 3, 2005 ➤ Subscribe ➤ Subscribe
Pfizer Inc VIAGRA sildenafil citrate TABLET;ORAL 020895-003 Mar 27, 1998 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for sildenafil citrate

Supplementary Protection Certificates for sildenafil citrate

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

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Serving leading biopharmaceutical companies globally:

Fuji
Boehringer Ingelheim
McKesson
Baxter
Mallinckrodt
Julphar
Fish and Richardson
Cipla
Novartis

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