SILDENAFIL CITRATE - Generic Drug Details

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, Chartwell Rx, Granules, Hetero Labs Ltd V, Invagen Pharms, Lupin Ltd, MSN, Novitium Pharma, 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, Jubilant Generics, Macleods Pharms Ltd, Mylan, Mylan Pharms Inc, Perrigo R And D, Reyoung, Rubicon Research, Sunshine, Teva, Teva Pharms, Torrent, Torrent Pharms Ltd, Umedica, and Watson Labs Inc, and is included in fifty-four NDAs. There are five 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-two suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for SILDENAFIL CITRATE

International Patents:	9
US Patents:	5
Tradenames:	4
Applicants:	37
NDAs:	54
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	62
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	145
Patent Applications:	7,660
Drug Prices:	Drug price trends 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

See drug sales revenues for SILDENAFIL CITRATE

Recent Clinical Trials for SILDENAFIL CITRATE

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

Sponsor	Phase
Assistance Publique - Hpitaux de Paris	PHASE2
Mater Medical Research Institute	PHASE3
University of Alabama at Birmingham	PHASE3

See all SILDENAFIL CITRATE clinical trials

Generic filers with tentative approvals for SILDENAFIL CITRATE

Applicant	Application No.	Strength	Dosage Form
		100MG	TABLET; ORAL
		50MG	TABLET; ORAL
		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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cmp Dev Llc	LIQREV	sildenafil citrate	SUSPENSION;ORAL	214952-001	Apr 28, 2023		DISCN	Yes	No	11,464,778		Y
Torrent	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	091448-002	Jun 11, 2018	AB	RX	No	No
Apotex Corp	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	091379-001	Nov 6, 2012		DISCN	No	No
Perrigo R And D	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	205791-001	Apr 23, 2020		DISCN	No	No
Ajanta Pharma Ltd	SILDENAFIL CITRATE	sildenafil citrate	TABLET;ORAL	206401-003	Oct 12, 2018	AB	RX	No	No

Expired US Patents for SILDENAFIL CITRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-002	Mar 27, 1998	6,469,012*PED
Viatris	REVATIO	sildenafil citrate	SOLUTION;INTRAVENOUS	022473-001	Nov 18, 2009	5,250,534*PED
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-003	Mar 27, 1998	5,250,534*PED
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-003	Mar 27, 1998	6,469,012*PED
Viatris	VIAGRA	sildenafil citrate	TABLET;ORAL	020895-002	Mar 27, 1998	5,250,534*PED

International Patents for SILDENAFIL CITRATE

Country	Patent Number	Title	Estimated Expiration
Australia	2018397436	Liquid oral formulations for PDE V inhibitors
Morocco	50320	Formulations orales liquides pour inhibiteurs de pde v
Canada	3086881	FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)
European Patent Office	3731870	FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)
Canada	3086881	FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)

Supplementary Protection Certificates for SILDENAFIL CITRATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0463756	SPC/GB99/004	United Kingdom		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		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	99C0007	Belgium		PRODUCT NAME: SILDENAFIL, NATL REGISTRATION NO/DATE: EU/1/98/077/001 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

Market Dynamics and Financial Trajectory for Sildenafil Citrate

Last updated: July 27, 2025

Introduction

Sildenafil citrate, widely known by its brand name Viagra, transformed the landscape of erectile dysfunction (ED) treatment since its Market approval in 1998. Its unique mechanism—vasodilation via phosphodiesterase type 5 (PDE5) inhibition—made it the first orally effective medication for ED, sparking a global pharmaceutical and healthcare movement. Over past decades, sildenafil's market dynamics and financial trajectory have been shaped by evolving patient demographics, regulatory shifts, competitive innovations, and emerging therapeutic applications.

This analysis explores sildenafil's current market conditions, growth drivers, challenges, and future prospects, providing critical insights for stakeholders in pharmaceutical investment, R&D, and healthcare strategy.

Market Overview and Size

Global Revenue and Market Penetration

The sildenafil citrate market has matured significantly since its debut. As of 2022, the global ED therapeutics market was valued at approximately USD 6.8 billion, with sildenafil accounting for around 45-50% of this segment, equating to roughly USD 3.0-3.4 billion annually [1]. This dominance stems from its established efficacy, familiarity among prescribers, and broad accessibility in many regions.

Regional Market Distribution

• North America: Leading market with high penetration due to mature healthcare infrastructure, favorable reimbursement policies, and heightened awareness.
• Europe: Similar to North America, with strong market presence but constrained by regulatory nuances.
• Asia-Pacific: Growing rapidly, driven by increasing awareness, urbanization, and younger demographics with emerging ED prevalence.
• Emerging Markets: Limited access and affordability remain challenges, but market potential grows as generics enter these regions.

Patent and Generic Landscape

Patent expiry in many jurisdictions around 2013-2018 led to an influx of generic sildenafil products, drastically reducing prices and boosting market volume. Generics now represent around 70% of sildenafil sales globally, heightening competition but ensuring affordability and widespread access.

Market Drivers

Aging Population and Rising ED Prevalence

Globally, the aging population—estimated to reach over 1 billion aged 60+ by 2025—propels demand, as ED prevalence increases with age. Lifestyle factors, comorbidities such as hypertension, diabetes, and cardiovascular disease (which often co-occur with ED), further expand the target patient base [2].

Increased Awareness and Acceptance

Increased social openness about sexual health issues reduces stigma. Physician awareness campaigns and direct-to-consumer advertising (particularly in North America and Europe) promote sildenafil use.

Broader Therapeutic Applications

Beyond ED, sildenafil exhibits promising off-label applications:

• Pulmonary arterial hypertension (PAH): The drug, marketed as Revatio, generated USD 250 million in 2022, expanding sildenafil’s market beyond ED [3].
• Altitude sickness and other off-label uses, although less prevalent, contribute to product diversification.

Product Innovation and Formulation Advancements

While the original sildenafil tablets remain dominant, new formulations (e.g., orodispersible, lower-dose variants, longer-acting formulations) aim to improve patient compliance and broaden usage contexts.

Market Challenges

Generic Competition and Price Erosion

Post-patent expiry, pricing pressures led to an over tenfold decrease in sildenafil's unit cost. Price competition compresses profit margins and limits revenue growth potential for branded formulations.

Regulatory and Patent Challenges

Generic manufacturers face minimal patent hurdles in markets where patents have expired, intensifying pricing and distribution competition.

Emergence of Novel PDE5 Inhibitors and Alternative Therapies

Newer drugs like tadalafil (Cialis) and vardenafil (Levitra) offer longer durations and different efficacy profiles, capturing portions of sildenafil’s market. Additionally, non-pharmacological treatments (psychotherapy, device-based therapies) diversify the ED treatment landscape.

Reimbursement and Prescription Trends

In many North American and European markets, sildenafil’s use is influenced by insurance coverage policies, cost considerations, and prescriber preferences, affecting volume sales.

Financial Trajectory and Investment Outlook

Revenue Trends

Following patent expiration, sildenafil’s revenues plateaued in developed markets but remained robust globally due to volume growth in emerging markets and generics. The global market is expected to grow at a CAGR of approximately 4% through 2028, reaching USD 4.2 billion by 2028, driven primarily by volume increases in developing regions [4].

Profitability and Market Share

Brand-name sildenafil, such as Viagra, retains premium pricing in select markets, aided by branded loyalty and formulations like Cialis or Levitra in other segments. However, generics command significant market share, pressuring margins for patent-holders.

Research and Development Investment

Pharmaceutical companies are investing in innovative sildenafil formulations, combination therapies, and new indications like heart failure or stroke rehabilitation, aiming for incremental revenue streams beyond traditional ED markets.

Strategic M&A Activity

Consolidations among generics producers and licensing deals for formulation licenses dominate recent M&A activities, enabling access to established brands and markets.

Emerging Opportunities and Future Market Directions

Expanding Indications

Ongoing clinical trials exploring sildenafil in neurodegenerative diseases, regenerative medicine, and COVID-19 related treatments present long-term growth avenues.

Personalized Medicine and Digital Health Integration

Developing targeted therapies based on genetic profiles or integrating digital tools (app-based dosing, adherence tracking) can optimize patient outcomes and expand sildenafil’s market reach.

Regulatory Digitalization and Market Access

Streamlined approval protocols and digital distribution platforms facilitate faster product launches, especially in emerging markets.

Conclusion

The sildenafil citrate market exemplifies a drug that revolutionized therapy but now faces a complex, competitive landscape. Patent expirations and price competition have shifted revenues from branded to generic segments, yet continuous innovation and expanding indications maintain its relevance. Growth remains sustainable, particularly in emerging markets, supported by aging demographics, rising awareness, and therapeutic diversification.

Stakeholders must navigate existing challenges through innovation, strategic licensing, and targeted market expansion. By capitalizing on new indications and advanced formulations, sildenafil’s financial trajectory can sustain steady growth over the next decade.

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Key Takeaways

• Market saturation in developed regions constrains revenue growth; emerging markets offer significant growth potential.
• Generic competition has driven prices down, compelling manufacturers to innovate through formulations and indications.
• Expansion into new therapeutic areas, such as pulmonary hypertension and neurodegeneration, diversifies revenue streams.
• Continued investment in R&D for improved delivery systems and personalized approaches will be vital.
• Regulatory and reimbursement landscapes will profoundly influence future market access and profitability.

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FAQs

1. What is the current market share of sildenafil among ED treatments?
   Sildenafil holds approximately 45-50% of the global ED therapeutics market, benefiting from early market entry, established efficacy, and wide availability.

2. How does patent expiry impact sildenafil’s revenue?
   Patent expiry significantly reduces brand-name revenue due to generic competition, leading to price erosion but expanding market volume.

3. What are the emerging therapeutic indications for sildenafil?
   Beyond ED, sildenafil is used to treat pulmonary arterial hypertension (Revatio), and clinical trials are exploring its role in neurodegenerative diseases and stroke recovery.

4. Which regions are expected to drive future growth for sildenafil?
   Asia-Pacific and Latin America are projected to be key growth drivers via increasing healthcare penetration and demographic shifts.

5. What are the main challenges facing sildenafil’s market sustainability?
   Major challenges include generic price competition, competition from newer PDE5 inhibitors, regulatory barriers, and evolving treatment preferences.

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Sources

[1] Market Research Future, 2022. "Global Erectile Dysfunction Market."
[2] WHO, 2021. "Ageing and health."
[3] Pfizer Inc., 2022. "Revatio Sales Data."
[4] IQVIA, 2023. "Pharmaceutical Market Outlook."