VIAGRA Drug Patent Profile

Which patents cover Viagra, and when can generic versions of Viagra launch?

Viagra is a drug marketed by Viatris and is included in one NDA.

The generic ingredient in VIAGRA is sildenafil citrate. There are twenty drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Viagra

A generic version of VIAGRA was approved as sildenafil citrate by CHARTWELL RX on November 6^th, 2012.

Summary for VIAGRA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	156
Patent Applications:	6,159
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VIAGRA
Drug Sales Revenues:	Drug sales revenues for VIAGRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIAGRA
What excipients (inactive ingredients) are in VIAGRA?	VIAGRA excipients list
DailyMed Link:	VIAGRA at DailyMed

See drug prices for VIAGRA

See drug sales revenues for VIAGRA

Recent Clinical Trials for VIAGRA

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

Sponsor	Phase
Cairo University	Phase 1
The University of Texas Medical Branch, Galveston	Phase 2
Sohag University	Phase 1/Phase 2

See all VIAGRA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for VIAGRA

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

Paragraph IV (Patent) Challenges for VIAGRA

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 VIAGRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-001	Mar 27, 1998	AB	RX	Yes	No
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-002	Mar 27, 1998	AB	RX	Yes	No
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-003	Mar 27, 1998	AB	RX	Yes	Yes

Expired US Patents for VIAGRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-002	Mar 27, 1998
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-001	Mar 27, 1998
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-003	Mar 27, 1998

International Patents for VIAGRA

See the table below for patents covering VIAGRA around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	218945	Pirazolo-pirimidinon-származékok és a vegyületeket tartalmazó gyógyászati készítmények, eljárás a vegyületek és a készítmények előállítására (PYRAZOLO PYRIMIDINONE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM, PROCESS FOR PRODUCING THE COMPOUNDS AND THE COMPOSITIONS)
Hungary	211646
Brazil	9102560

Supplementary Protection Certificates for VIAGRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0463756	C990005	Netherlands		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		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	300048	Netherlands		PRODUCT NAME: ZOLMITRIPTANUM, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH AANVAARDBAAR ZOUT OF VAN EEN SOLVAAT; NATL. REGISTRATION: RVG 21079 RVG 21080 19970925; FIRST REGISTRATION: PL 12619/0116 19970307