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-two 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
Viatris	REVATIO	sildenafil citrate	TABLET;ORAL	021845-001	Jun 3, 2005	AB	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	5,250,534*PED
Viatris	REVATIO	sildenafil citrate	TABLET;ORAL	021845-001	Jun 3, 2005	5,250,534*PED

International Patents for REVATIO

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2114114	PYRAZOLOPYRIMIDINONE COMPOUNDS, PHARMACEUTICAL COMPOSITION, METHOD OF TREATMENT
South Africa	9104707
Portugal	98011	PROCESSO PARA A PREPARACAO DE PIRAZOLOPIRIMIDINONAS UTEIS COMO AGENTES ANTIANGINOSOS
Russian Federation	2047617	METHOD OF SYNTHESIS OF PYRAZOLOPYRIMIDINE COMPOUNDS OR THEIR PHARMACEUTICALLY ACCEPTABLE SALTS
Ireland	912094
Spain	2071919

Supplementary Protection Certificates for REVATIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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 REVATIO

Last updated: July 28, 2025

Introduction

REVATIO (sildenafil citrate) is a pivotal pharmaceutical product primarily utilized for treating pulmonary arterial hypertension (PAH). Originally discovered and marketed as a treatment for erectile dysfunction under the brand Viagra, sildenafil’s versatility has impelled its repositioning for PAH management, leading to the development of REVATIO by Pfizer. Understanding its market dynamics and financial trajectory offers valuable insights into its current and future commercial potential, driven by evolving therapeutic landscapes, regulatory shifts, and competitive factors.

Historical Context and Drug Development

Sildenafil’s journey from erectile dysfunction therapy to pulmonary hypertension illustrates the strategic repositioning common in pharmaceutical innovation. Approved by the FDA in 2005 for PAH, REVATIO benefits from Pfizer’s extensive global distribution network. The drug’s mechanism—vasodilation via phosphodiesterase-5 (PDE5) inhibition—addresses a critical unmet need in PAH, a rare but debilitating condition characterized by increased pulmonary vascular resistance.

The initial launch of REVATIO capitalized on sildenafil’s established safety profile and patient familiarity, which facilitated swift market penetration. Over time, Pfizer expanded its indications and approved formulations, including oral tablets suitable for chronic management of PAH.

Market Size and Demand Drivers

Prevalence and Incidence of PAH

PAH affects approximately 15–50 individuals per million worldwide, with variations driven by geography and diagnostic criteria [1]. The disease’s progressive nature and high mortality rates underscore the demand for effective long-term therapies such as REVATIO.

Treatment Paradigms and Patient Segmentation

Current PAH management involves complex regimens combining prostanoids, endothelin receptor antagonists, and PDE5 inhibitors like sildenafil. REVATIO’s role is often as a first-line or adjunct therapy, influencing its sales trajectory. The patient population predominantly comprises adults aged 30-60, with a rising trend driven by better diagnosis and increased awareness.

Market Penetration and Adoption

Despite its foundational role, REVATIO faces competitive pressures from newer PDE5 inhibitors like tadalafil (Adcirca), which offer dosing flexibility, and from emerging treatments such as soluble guanylate cyclase stimulators and selective prostacyclin analogs [2]. Nonetheless, Pfizer’s established presence and extensive distribution bolster REVATIO’s market share.

Competitive Landscape

Key Competitors and Innovations

• Tadalafil (Adcirca): Approved by the FDA in 2009 for PAH, with longer half-life facilitating once-daily dosing. Its distinct pharmacokinetics have made it a preferred choice in some markets [3].

• Era of Novel Agents: The advent of drugs like riociguat (Adempas) and selexipag (Uptravi) presents competition, especially in patients refractory to PDE5 inhibitors.

• Combination Therapies: Increasing reliance on combination regimens influences REVATIO’s positioning and sales, as clinicians seek the most effective therapeutic combinations.

Regulatory and Reimbursement Factors

Regulatory landscapes in different countries influence drug access and sales. Approval of generic sildenafil formulations impacts revenues by introducing cost competition, although Pfizer maintains patent protections and proprietary formulations in key markets to sustain exclusivity.

Reimbursement policies vary, with coverage influencing prescribing behaviors. The entry of biosimilars or generics could challenge Revatio’s market dominance post-patent expiry.

Pricing and Revenue Trends

Pfizer’s pricing strategies aim to balance profitability with market access. Historically, REVATIO has commanded premium pricing due to its niche indication and brand recognition. In the US, the wholesale acquisition cost (WAC) hovers around $1,200–$1,500 per month for branded formulations [4].

Patent protections, exclusivity periods, and competition from generics substantially affect revenue peaks and troughs. An analysis of recent quarter-on-quarter sales indicates fluctuations aligned with patent status and competitive pressures.

Regulatory Developments and Market Expansion

Regulatory agencies continue to evaluate sildenafil’s safety profile, with post-marketing surveillance reaffirming its suitability for PAH. Emerging indications, such as treatment of digital ulcers in systemic sclerosis-related PAH, may influence future approval pathways, expanding the drug’s market footprint.

Market expansion is also driven by global health initiatives, increasing availability in emerging markets, and local regulatory approvals. The asymmetric distribution infrastructure affects geographical sales, with North America and Europe constituting the largest revenue pools.

Financial Trajectory and Future Outlook

Current Financial Position

Pfizer’s annual revenues attributable to REVATIO have fluctuated due to patent expirations and competitive challenges. Nonetheless, it remains a significant component within the company’s specialty portfolio, with steady sales driven by chronic management needs.

Projected Growth and Challenges

The future financial trajectory hinges on several factors:

• Patent Expiry: Loss of exclusivity typically results in significant revenue decline due to generic entry. Pfizer’s strategic lifecycle management, including patent extensions and formulation improvements, aims to mitigate this impact.

• Emerging Therapies: Competition from novel PAH treatments may supplant REVATIO’s market share, especially in treatment-resistant cases, necessitating continuous innovation.

• Market Penetration in Emerging Regions: Increased access and local approvals could foster growth, offsetting saturation in mature markets.

• Regulatory Approvals for New Indications: Successful expansion into additional therapeutic areas could unlock new revenue streams.

Strategic Initiatives

Pfizer’s efforts include optimizing formulation delivery, pursuing new indications, and leveraging real-world evidence to support repositioning. The strategic focus on personalized medicine and combination therapies may also influence REVATIO’s market longevity.

Conclusion

REVATIO exemplifies a successful repositioning of a well-known drug into a niche but significant market segment. Its market dynamics are shaped by a confluence of clinical demand, competitive innovation, regulatory policies, and pricing strategies. While patent protections have historically driven revenue, impending generic entries pose challenges. However, strategic positioning through new indications, global expansion, and formulation innovations remain crucial to sustaining its financial trajectory. Stakeholders must monitor evolving therapeutic paradigms and competitive shifts to optimize investment and commercialization strategies.

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Key Takeaways

• Market dependence: REVATIO’s revenues depend heavily on the prevalence of PAH, treatment paradigms, and geographic market penetration.

• Competitive landscape: The rise of alternatives like tadalafil and emerging novel agents challenge REVATIO’s market share, necessitating continual innovation and strategic positioning.

• Regulatory and patent lifecycle: Patent expirations significantly impact profitability; proactive patent management and formulation improvements are critical.

• Global expansion: Emerging markets offer growth potential through increased diagnosis, approval, and reimbursement, counterbalancing saturation in developed regions.

• Future directions: Expanding indications, formulation enhancements, and managing competitive threats are vital for maintaining and growing REVATIO’s financial trajectory.

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FAQs

1. What factors influence REVATIO’s market share in pulmonary arterial hypertension?
   Factors include the prevalence of PAH, treatment preferences (monotherapy vs. combination), competition from other PDE5 inhibitors, regulatory approvals, and reimbursement policies.

2. How does patent expiry affect REVATIO’s revenues?
   Patent expiry typically leads to generic competition, substantially reducing prices and sales volumes, unless Pfizer secures patent extensions or formulates new delivery methods.

3. Are there upcoming indications that could expand REVATIO’s use?
   Current research explores sildenafil’s potential for digital ulcers in systemic sclerosis-associated PAH and other rare vascular conditions, which could open new markets if approved.

4. What competitive advantages does REVATIO hold over newer therapies?
   Its long-standing market presence, established safety profile, and patient familiarity confer advantages, but overcoming newer agents’ convenience and efficacy remains challenging.

5. What strategies can Pfizer implement to sustain REVATIO’s profitability?
   Focus on formulation innovations, pursuing new indications, geographic expansion, and lifecycle management through patent strategies are key options.

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References

[1] McGoon, M. D., et al. "The prevalence of pulmonary arterial hypertension: Global estimates." American Journal of Cardiology, 2006.

[2] Galiè, N., et al. "Treatment strategies for pulmonary arterial hypertension." European Respiratory Journal, 2019.

[3] Sitbon, O., et al. "Long-term effects of tadalafil in pulmonary arterial hypertension." European Respiratory Journal, 2012.

[4] Drugs.com, "Revatio (sildenafil) pricing," 2023.