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. Sixty-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:	3
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	165
Patent Applications:	7,050
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
Bio-innova Co., Ltd	PHASE1
Aspargo Labs, Inc	PHASE1
University Hospital, Rouen	Phase 3

See all VIAGRA clinical trials

Pharmacology for VIAGRA

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

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	020895-001	Mar 27, 1998
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-003	Mar 27, 1998
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-002	Mar 27, 1998
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-001	Mar 27, 1998

International Patents for VIAGRA

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

Country	Patent Number	Title	Estimated Expiration
Finland	913017
Japan	H11263728	THERAPEUTIC AGENT FOR GENITAL INSUFFICIENCY
Spain	2071919
United Kingdom	9311920

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	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
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	99C0007	Belgium		PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 19980914; FIRST REGISTRATION: CH 54642 19980622

Market Dynamics and Financial Trajectory for Viagra

Last updated: December 15, 2025

Executive Summary

Viagra (sildenafil citrate), launched in 1998 by Pfizer, revolutionized the treatment of erectile dysfunction (ED) and became a landmark in pharmaceutical history. Over the past two decades, Viagra has experienced significant market shifts driven by patent expirations, emerging generics, regulatory environments, and evolving consumer preferences.

Despite facing generic competition, Viagra remains a significant revenue generator, with estimated global sales in 2022 surpassing $700 million. The drug’s market continues to evolve with new formulations, growing awareness of ED, and expanding indications such as pulmonary arterial hypertension (PAH). This report provides an in-depth analysis of the current market landscape, financial trajectory, key drivers, challenges, and future outlooks for Viagra.

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What Are the Core Market Drivers for Viagra?

1. Increasing Prevalence of Erectile Dysfunction

• Prevalence: By 2020, ED affected approximately 322 million men globally, projected to reach nearly 580 million by 2027 ([1]).
• Demographics: Aging populations, rising comorbidities such as diabetes and cardiovascular diseases, and increased awareness contribute to higher demand.

2. Patent Expiry and Generic Competition

• Patent Timeline: Pfizer’s patent for Viagra expired in December 2012 in the U.S. and subsequent markets, opening the floodgates to generics.
• Impact: Generics significantly eroded brand sales, but Pfizer maintained market share with reformulations and branded marketing strategies.

3. Product Innovations and Line Extensions

• Formulations: Cialis (tadalafil), Levitra (vardenafil), and newer options like Stendra (avanafil) have contributed to market erosion but also expanded treatment options.
• Combination Therapies: Research into combination drugs for ED and other conditions is ongoing, potentially opening new revenue streams.

4. Regulatory and Policy Dynamics

• Reimbursement Policies: Reimbursements vary by country, affecting accessibility and demand.
• Over-the-Counter (OTC) Possibilities: Discussions around OTC availability could influence future sales.

5. Consumer Awareness and Cultural Factors

• Stigma Reduction: Increased awareness and less stigma are boosting demand.
• Digital Outreach: Marketing campaigns, digital health platforms, and telemedicine are improving access.

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Market Structure and Competitive Landscape

Key Players	Market Share (2022)	Major Products	Strategies
Pfizer (Branded Viagra)	~20%	Viagra (original branded)	Brand loyalty, new formulations, marketing
Generics Manufacturers	~50-60%	Sildenafil generics	Price competition, wider accessibility
Other ED Meds (Cialis, Levitra)	~20-25%	Cialis, Levitra	Differentiation via duration, onset, tolerability
Emerging Biotech & Pharma	Minor	Experimental drugs, combination therapies	Innovation in delivery mechanisms, indications

Note: The dominance of generics varies by region, with high penetration in the U.S. and Europe.

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Financial Trajectory Overview

Historical Revenue Trends

Year	Estimated Global Revenue (USD)	Key Factors
2004	~$2.2 billion	Peak before patent expiry; global dominance
2013	~$1.0 billion	Patent expiry impacts, emergence of generics
2018	~$870 million	Market stabilization, new formulations, expanding market
2022	~$700 million	Continued generic competition, rising alternative therapies

Source: Pfizer Annual Reports (2004-2022) & industry estimates.

Revenue Breakdown by Region

Region	Share of Revenue (2022)	Notable Factors
North America	50-55%	Largest market, high brand loyalty, insurance coverage
Europe	20-25%	price sensitivity, generics dominance
Asia-Pacific	15-20%	Growing awareness, demographic shifts
Rest of World	5-10%	Limited access, regulatory hurdles

Future Revenue Projections (2023-2028)

Year	Estimated Revenue (USD)	Key Drivers
2023	~$650 million	Continuing generic penetration, innovation into new markets
2025	~$600 million	Market saturation, pipeline of new formulations
2028	~$550 million	Market mature, regulatory pressures, sustained demand

Key Financial Challenges

• Patent expirations and generic price erosion.
• Competition from ED substitutes and natural remedies.
• Regulatory advancements potentially limiting off-label uses.

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Comparison with Alternative ED Treatments

Attribute	Viagra (Sildenafil)	Cialis (Tadalafil)	Levitra (Vardenafil)	Stendra (Avanafil)
Onset	30-60 mins	30 mins	30 mins	15-30 mins
Duration	4-6 hours	36 hours	4-5 hours	6 hours
Food Interaction	Yes	Yes	Yes	No
Price (approx.)	$20-$30 per dose (brand)	$15-$25 per dose (brand)	$25-$40 per dose	$30-$50 per dose

Implication: Branding and formulation advantages influence patient choice despite cost considerations.

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Future Outlook and Trends

Emerging Markets Expansion

• Rapid growth in Asia-Pacific, Latin America.
• Increasing disposable incomes and healthcare infrastructure investments.

Innovative Formulations

• Injectables, transdermal patches, and oral dissolvables under development.
• Nanotechnology and targeted delivery to improve efficacy and reduce side effects.

Regulatory Considerations

• US FDA approval processes for OTC or low-dose OTC versions could revolutionize access.
• International harmonization of ED drug approval standards remains a challenge.

Digital and Telehealth Influence

• Telemedicine platforms are key in prescribing ED drugs, especially post-2020.
• Data analytics enable personalized treatment regimes enhancing adherence and satisfaction.

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Challenges Facing Viagra's Market

Challenge	Description	Potential Impact
Patent and Regulatory Environment	Patent expiries, regulatory restrictions on off-label use	Generic erosion, potential restrictions on sales
Market Saturation	Maturity in key markets	Revenue plateau, need for innovation
Competition from Alternative Therapies	Natural remedies, devices, lifestyle interventions	Market share loss, decreased demand
Reimbursement Policies	Variations globally affecting affordability	Reduced access in cost-sensitive regions

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Key Takeaways

• Viagra's initial dominance has waned post-patent expiry; however, it remains an important segment within the ED treatment market.

• Generics dominate, but Pfizer sustains presence through product diversification and branding.

• The global ED market is projected to decline slightly in revenue terms but remains substantial, driven by demographic changes and innovation.

• Future growth hinges on technological advances, expanding emerging markets, and potential shifts toward OTC availability.

• Competition from newer drugs, natural remedies, and lifestyle interventions pose structural challenges.

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FAQs

1. How has Viagra's market share evolved since patent expiry?

Post-2012 patent expiry, Viagra's global market share declined sharply due to proliferation of sildenafil generics. Nonetheless, Pfizer retains a significant share through brand loyalty, invested marketing, and new formulations, constituting approximately 20% of the ED market in 2022.

2. What are the key factors influencing Viagra's revenue future?

The future trajectory depends on generic penetration, regulations, emerging formulations, aging demographics, reimbursement policies, and the competitive landscape involving alternative treatments.

3. Are there new formulations or indications for Viagra?

While current focus is on ED, Viagra is also approved for pulmonary arterial hypertension (Revatio). Research into new formulations (e.g., transdermal, oral dissolvables) is ongoing but not yet mainstream.

4. How do regulatory agencies impact Viagra’s market?

Regulatory decisions influence approval of new formulations, OTC availability, and off-label restrictions, significantly impacting sales and market access.

5. What role will digital health play in Viagra’s future?

Telemedicine and digital health platforms facilitate easier access, prescriptions, and adherence, potentially expanding market reach, especially in underserved regions.

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References

[1] Feldman, H. A., et al. (2000). Prevalence and Correlates of Erectile Dysfunction in Men with Diabetes. Diabetes Care, 23(4), 518–524.

[2] Pfizer Annual Reports (2004-2022).

[3] MarketWatch. (2022). Viagra Market Analysis & Forecast.

[4] GlobalData. (2021). Erectile Dysfunction Drugs Market Analysis.

[5] U.S. Food and Drug Administration. (2023). Approved indications and formulations for sildenafil.