Sildenafil citrate - Generic Drug Details

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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 four branded drugs marketed by Viatris, Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Granules, Hetero Labs Ltd V, Invagen Pharms, Lupin Ltd, MSN, Novitium Pharma, Somerset Theraps Llc, Taro, Teva Pharms Usa, Tris Pharma Inc, Zydus Lifesciences, Eugia Pharma, Cmp Dev Llc, Actavis Grp Ptc, Amneal Pharms Ny, Apotex Corp, Appco, Cadila Pharms Ltd, Chartwell Rx, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Perrigo R And D, Reyoung, Rubicon, Sunshine, Teva, Teva Pharms, Torrent, Torrent Pharms Ltd, Umedica, and Watson Labs Inc, and is included in fifty-two NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Sildenafil citrate has nine patent family members in nine countries.

There are eighteen drug master file entries for sildenafil citrate. Sixty-eight suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for sildenafil citrate

International Patents:	9
US Patents:	4
Tradenames:	4
Applicants:	37
NDAs:	52
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	68
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	138
Patent Applications:	7,181
Drug Prices:	Drug price trends for sildenafil citrate
Drug Sales Revenues:	Drug sales revenues for sildenafil citrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sildenafil citrate
What excipients (inactive ingredients) are in sildenafil citrate?	sildenafil citrate excipients list
DailyMed Link:	sildenafil citrate at DailyMed

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

Sponsor	Phase
Batterjee Medical College	Phase 4
University of Pennsylvania	Phase 2
Ladoke Akintola University of Technology Teaching Hospital, Ogbomoso	Phase 4

See all sildenafil citrate clinical trials

Generic filers with tentative approvals for SILDENAFIL CITRATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	100MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	50MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	25MG	TABLET; 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

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for sildenafil citrate

Phosphodiesterase 5 Inhibitors
Urological Agents
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for sildenafil citrate

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for SILDENAFIL CITRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIAGRA	Tablets	sildenafil citrate	25 mg and 50 mg	020895	1	2004-11-19
VIAGRA	Tablets	sildenafil citrate	100 mg	020895	1	2004-10-25

US Patents and Regulatory Information for sildenafil citrate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rubicon	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	204882-001	Jun 11, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms Ny	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	202023-003	Jun 27, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	201171-001	Mar 25, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	SILDENAFIL CITRATE	sildenafil citrate	FOR SUSPENSION;ORAL	215522-001	Nov 16, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	REVATIO	sildenafil citrate	SOLUTION;INTRAVENOUS	022473-001	Nov 18, 2009	⤷ Sign Up	⤷ Sign Up
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-001	Mar 27, 1998	⤷ Sign Up	⤷ Sign Up
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-001	Mar 27, 1998	⤷ Sign Up	⤷ Sign Up
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-003	Mar 27, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for sildenafil citrate

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Country	Patent Number	Title	Estimated Expiration
Australia	2018397436	Liquid oral formulations for PDE V inhibitors	⤷ Sign Up
Morocco	50320	Formulations orales liquides pour inhibiteurs de pde v	⤷ Sign Up
Singapore	11202006080S	LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS	⤷ Sign Up
European Patent Office	3731870	FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for sildenafil citrate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0463756	SPC/GB99/004	United Kingdom	⤷ Sign Up	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	C990005	Netherlands	⤷ Sign Up	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	5/1999	Austria	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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