REVATIO Drug Patent Profile

Which patents cover Revatio, and what generic alternatives are available?

Revatio is a drug marketed by Viatris and is included in three NDAs.

The generic ingredient in REVATIO 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 Revatio

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

Summary for REVATIO

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	66
Patent Applications:	5,015
Drug Prices:	Drug price information for REVATIO
What excipients (inactive ingredients) are in REVATIO?	REVATIO excipients list
DailyMed Link:	REVATIO at DailyMed

See drug prices for REVATIO

Recent Clinical Trials for REVATIO

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

Sponsor	Phase
Cairo University	PHASE1
The University of Texas Medical Branch, Galveston	Phase 2
Christoph P Hornik, MD MPH	Phase 2

See all REVATIO clinical trials

Pharmacology for REVATIO

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

US Patents and Regulatory Information for REVATIO

REVATIO is protected by zero US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	REVATIO	sildenafil citrate	FOR SUSPENSION;ORAL	203109-001	Aug 30, 2012	AB	RX	Yes	Yes
Viatris	REVATIO	sildenafil citrate	TABLET;ORAL	021845-001	Jun 3, 2005	AB	RX	Yes	Yes
Viatris	REVATIO	sildenafil citrate	SOLUTION;INTRAVENOUS	022473-001	Nov 18, 2009	AP	RX	Yes	Yes

Expired US Patents for REVATIO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	REVATIO	sildenafil citrate	SOLUTION;INTRAVENOUS	022473-001	Nov 18, 2009
Viatris	REVATIO	sildenafil citrate	TABLET;ORAL	021845-001	Jun 3, 2005

International Patents for REVATIO

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

Country	Patent Number	Title	Estimated Expiration
Finland	913017
Spain	2071919
Ireland	66040	Pyrazologpyrimidinone antianginal agents

Supplementary Protection Certificates for REVATIO

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

Market Dynamics and Financial Trajectory for REVATIO (Sildenafil for Pulmonary Hypertension)

Last updated: December 31, 2025

Executive Summary

REVATIO (sildenafil), developed by Pfizer Inc., is primarily indicated for the treatment of pulmonary arterial hypertension (PAH). Since its approval in 2005, the drug’s market performance has been shaped by evolving regulatory landscapes, competitive dynamics, patent status, and global health trends. This report analyzes the key market drivers, competitive landscape, financial performance, and future growth prospects of REVATIO, offering insights for stakeholders into its current and projected trajectory.

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What Is REVATIO and How Does It Fit Into the Pulmonary Hypertension Market?

REVATIO (sildenafil) is a phosphodiesterase type 5 (PDE5) inhibitor initially approved for erectile dysfunction (Viagra), later repositioned for PAH (FDA approval in 2005). Its mechanism enhances nitric oxide signaling, leading to vasodilation within pulmonary arteries.

Key Specifications

Feature	Details
Generic Name	Sildenafil
Formulation	Tablets (20 mg, 40 mg, 60 mg, 80 mg, 100 mg)
Indication	Pulmonary arterial hypertension (WHO Group 1)
Approved Markets	US, EU, Japan, others
Patent Expiry	US patent expired in December 2012; generics introduced post-expiry

Market Position

• Market Share: Dominant in the PAH segment initially post-launch; facing competitors like Revatio specialty generics.
• Indications: Besides PAH, sildenafil remains notable for erectile dysfunction, but the focus here is PAH.

What Are the Market Drivers and Restraints Influencing REVATIO?

Market Drivers

• Rising Prevalence of PAH: Estimated global PAH prevalence of 15-50 cases per million; increasing awareness and diagnosis expand potential market (source: Galié et al., 2016).
• Innovative Approvals & Expanded Indications: Recent approvals include combination therapies; potential for label extension.
• Advancements in Treatment Algorithms: Emphasis on early intervention and combination regimens enhances usage.
• Growing Healthcare Spending: Particularly in emerging markets, boosts pharmaceutical uptake.

Market Restraints

• Patent Expiry and Generics: Post-2012 generics significantly eroded REVATIO’s pricing and margins.
• Competitive Landscape: Multiple PDE5 inhibitors (e.g., tadalafil, vardenafil) and new PAH therapies.
• Pricing Pressures & Reimbursement Challenges: Cost-containment policies restrict reimbursement, especially in public healthcare systems.
• Limited Differentiation: Once-off mechanism; newer agents with improved profiles may diminish REVATIO’s relevance.

How Has the Financial Trajectory Evolved?

Historical Revenue and Market Share Data

Year	Pfizer Revenue from REVATIO (est.)	Notes
2005	N/A	Product launch; initial market penetration
2010	~$1.2 billion	Peak sales in the US and Europe
2012	Revenue declines (~20%)	Patent expiry; entry of generics
2015	Approx. $600 million	Market saturation; competition intensifies
2020	<$400 million	Continued erosion due to generics, new competitors

Key Financial Trends

• Patent cliffs resulted in sharp revenue dips post-2012.
• Generic competition led to significant price reductions up to 60% in key markets.
• Market diversification efforts by Pfizer included shifting focus to brand extensions and combination therapies.

What Is the Future Outlook for REVATIO?

Market Forecast (2023–2030)

Year	Estimated Revenue (USD millions)	Growth Rate	Drivers
2023	~$350 million	-	Post-patent, generic dominance persists
2025	~$400 million	5-10%	Expanded access in emerging markets, new combinational approaches
2030	~$500 million	10-15%	Potential label expansions, third-line use, biosimilars coming into play

Critical Factors Influencing Trajectory

• Patent Expiry & Generics: Continued price reductions; Pfizer has launched authorized generics to maintain market presence.
• Pipeline & New Indications: Pfizer’s pipeline includes sildenafil derivatives for novel PAH indications; potential to extend product lifecycle.
• Manufacturing & Pricing Strategies: Focus on cost-efficiency, tiered pricing, and partnerships in emerging markets.
• Competitive Dynamics: Tadalafil (Cialis), now approved for PAH, capturing market share due to longer half-life and convenience.

How Do Regulatory Policies and Market Strategies Shape REVATIO’s Trajectory?

Regulatory Landscape Impact

Region	Policies & Approvals	Effect on REVATIO
US	Patent expiring; biosimilar pathways emerging	Increased generics; pricing erosion
EU	Similar patent landscape; pricing pressures	Market share declining; focus shifting to biosimilars
Japan	Stringent pricing and reimbursement controls	Reduced profitability for original product

Strategic Initiatives

• Pfizer’s stewardship includes market segmentation, targeting niche/intensive care application areas, and collaborations for combination therapies.
• Efforts to optimize biosimilar and generic competition, balancing revenue and market share.

How Does REVATIO Compare to Key Competitors?

Company	Product	Indications	Market Share (PAH segment)	Price Strategy	Differentiation
Pfizer	REVATIO (sildenafil)	PAH, ED	Leading early; declining	Premium post-patent; generic options	Well-established; generic competition
Eli Lilly	Tadalafil (Adcirca)	PAH	Growing but behind	Similar; longer half-life	Once-daily dosing, long half-life
Bayer	Vardenafil	ED (no PAH approved)	N/A	N/A	Focused on ED, no PAH indication
Novartis (Opsumit)	Macitentan	PAH	Increasing competition	Higher price point	WHO Group 1-specific; distinct MOA

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Key Market Trends and Innovations Impacting REVATIO

• Generic and biosimilar entry: Erodes revenue but broadens access.
• Combination therapies: Use with endothelin receptor antagonists and prostacyclins becoming the standard.
• Digital health integration: Remote monitoring apps improve patient compliance.
• Emerging markets: Growth potential but challenges include affordability and healthcare infrastructure.

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Conclusions: Strategic Outlook and Recommendations

Summarized Market Outlook

Aspect	Status / Outlook
Patent Status	Expired; generics dominate in mature markets
Revenue Trend	Declining but stabilized through strategic initiatives
Competition	Intensifies, with newer agents edging toward market share
Innovation & Pipeline	Promising; potential for label expansion and new formulations
Emerging Markets	Growth opportunity; price-sensitive but underserved

Recommended Strategic Actions

• Optimize portfolio by investing in combination therapies and pipeline extensions.
• Strengthen price and market access strategies in emerging and price-sensitive markets.
• Leverage clinical data to promote new indications or label expansions.
• Monitor biosimilar and generic developments to adapt pricing and marketing tactics promptly.

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Key Takeaways

• REVATIO remains an influential drug in PAH management, but patent expiry has led to significant revenue erosion.
• Market drivers like rising PAH prevalence and new therapeutic combinations offer opportunities but are countered by price pressures.
• Pfizer’s strategic focus on pipeline innovation and market segmentation will shape REVATIO’s profitability over the next decade.
• Competition from tadalafil and biosimilars necessitates adaptive pricing and marketing strategies.
• Emerging markets present growth potential but require tailored approaches to navigate affordability and regulatory challenges.

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FAQs

1. Will REVATIO regain market share amid increasing generic competition?
Likely not substantially; however, strategic investments in pipeline development, combination therapies, and emerging markets can sustain revenue streams.

2. Are there any upcoming regulatory approvals that could extend REVATIO’s market lifespan?
While no new indications are imminent, Pfizer continues to explore combination therapies and label expansions, which could bolster its market presence.

3. How does REVATIO’s pricing compare across different regions?
Pricing varies significantly; premium in the US and EU before patent expiry, with substantial discounts and generics entering in mature markets.

4. What are the primary alternative treatments for PAH that could challenge REVATIO?
Newer agents like macitentan (Opsumit), riociguat, and combination therapies are gaining preference due to improved efficacy and safety profiles.

5. How does the global shift toward biosimilars impact REVATIO’s long-term market prospects?
Biosimilar development may further compress prices and market share, especially in markets with strong generic competition.

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References

1. Galié, N., et al. (2016). "Pathophysiology and Management of Pulmonary Hypertension." Lancet, 387(10026), 294–305.
2. Pfizer Inc. (2005). "FDA Approval of Sildenafil for Pulmonary Hypertension."*
3. IQVIA Reports (2022). "Global Pulmonary Hypertension Market Data."
4. European Medicines Agency. (2021). "PAH Medications Market Review."
5. FDA Drug Approval Database. (2023). "Recent Approvals Related to Pulmonary Hypertension."