AVANAFIL - Generic Drug Details

What are the generic drug sources for avanafil and what is the scope of freedom to operate?

Avanafil is the generic ingredient in two branded drugs marketed by Hetero Labs Ltd V and Vivus Llc, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Avanafil has forty-one patent family members in twenty-five countries.

There are five drug master file entries for avanafil. Two suppliers are listed for this compound.

Summary for AVANAFIL

International Patents:	41
US Patents:	1
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	25
Patent Applications:	3,801
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVANAFIL
What excipients (inactive ingredients) are in AVANAFIL?	AVANAFIL excipients list
DailyMed Link:	AVANAFIL at DailyMed

Recent Clinical Trials for AVANAFIL

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

Sponsor	Phase
Assiut University	PHASE3
University of Alexandria	Phase 4
Johns Hopkins University	Phase 1/Phase 2

See all AVANAFIL clinical trials

Pharmacology for AVANAFIL

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for AVANAFIL

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

Paragraph IV (Patent) Challenges for AVANAFIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
STENDRA	Tablets	avanafil	50 mg, 100 mg and 200 mg	202276	1	2016-04-27

US Patents and Regulatory Information for AVANAFIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-003	Apr 27, 2012	AB	RX	Yes	Yes	6,656,935		Y	Y
Hetero Labs Ltd V	AVANAFIL	avanafil	TABLET;ORAL	209266-001	Jun 14, 2024	AB	RX	No	No
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012	AB	RX	Yes	No
Hetero Labs Ltd V	AVANAFIL	avanafil	TABLET;ORAL	209266-003	Jun 14, 2024	AB	RX	No	No
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-001	Apr 27, 2012	AB	RX	Yes	No
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012	AB	RX	Yes	No	6,656,935		Y	Y

Expired US Patents for AVANAFIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-003	Apr 27, 2012	7,501,409
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012	6,656,935
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-003	Apr 27, 2012	6,656,935
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-001	Apr 27, 2012	6,656,935
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012	7,501,409
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-001	Apr 27, 2012	7,501,409

EU/EMA Drug Approvals for AVANAFIL

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Menarini International Operations Luxembourg S.A.	Spedra	avanafil	EMEA/H/C/002581Treatment of erectile dysfunction in adult men.In order for Spedra to be effective, sexual stimulation is required.	Authorised	no	no	no	2013-06-21	2013-04-26

International Patents for AVANAFIL

Country	Patent Number	Title	Estimated Expiration
China	102584799
Brazil	PI0014526	compostos cíclicos de seis elementos contendo nitrogênio aromático, composição farmacêutica e uso do mesmo
Taiwan	I258471
Bulgaria	65453
Argentina	025668	COMPUESTOS CICLICOS DE 6 MIEMBROS CONTENIENDO NITRoGENO AROMÁTICOS.
European Patent Office	1277741

Supplementary Protection Certificates for AVANAFIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1219609	SPC/GB13/071	United Kingdom		PRODUCT NAME: AVANAFIL; REGISTERED: UK EU/1/13/841 20130621
1219609	476	Finland
1219609	92249	Luxembourg		PRODUCT NAME: AVANAFIL
1219609	2013C/051	Belgium		PRODUCT NAME: AVANAFIL; AUTHORISATION NUMBER AND DATE: EU/1/13/841 20130624
1219609	122013000096	Germany		PRODUCT NAME: AVANAFIL UND SEINE PHARMAZEUTISCH ANNEHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609	C300618	Netherlands		PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621

Market Dynamics and Financial Trajectory for Avanafil

Last updated: July 27, 2025

Introduction

Avanafil, marketed primarily under the brand name Stendra in the United States and Spedra in Europe, is a phosphodiesterase type 5 (PDE5) inhibitor approved for the treatment of erectile dysfunction (ED). Since its approval in 2012—first in the US by the FDA—Avanafil has entered a competitive landscape dominated by established agents like sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra). Its unique pharmacokinetics and safety profile have been pivotal in shaping its market evolution. This analysis explores the current market dynamics and projects the financial trajectory of Avanafil, considering factors such as patent status, competitive positioning, regulatory developments, and evolving patient preferences.

Market Overview

The global erectile dysfunction market is valued at approximately USD 4.7 billion as of 2022, with a compound annual growth rate (CAGR) of around 6% projected through 2027 (Research and Markets). The growth is driven by increasing aging populations, rising awareness about ED treatments, and expanding healthcare access. Among PDE5 inhibitors, sildenafil retains dominance due to its first-mover advantage and extensive generic availability, but newer agents like Avanafil differentiate through rapid onset and favorable side effect profiles.

In this context, Avanafil occupies a niche as a "next-generation" PDE5 inhibitor, targeting patients seeking fast action and reduced side effects. Its selectivity for PDE5 over PDE6 minimizes visual disturbances—a notable concern for some users of earlier agents—enhancing its appeal.

Market Dynamics

1. Patent and Regulatory Environment

Avanafil's initial patent protection extended into the late 2020s, with some formulations protected until approximately 2029–2030. The expiration of patents mandates the entry of generics, potentially eroding market share and compressing profit margins. However, as of recent years, patent cliff effects have yet to fully materialize, allowing continued revenue streams.

Regulatory pathways in emerging markets remain vital, as approvals expand globally. Increasing approval in Asian, Middle Eastern, and Latin American markets broadens the patient base, although local patent laws and pricing regulations influence market penetration.

2. Competitive Positioning & Brand Differentiation

Avanafil’s relatively fast onset (within 15 minutes) and minimal visual side effects have been significant differentiators, especially for patients prioritizing spontaneity and safety. Yet, high brand loyalty to established drugs and the extensive availability of generics for sildenafil threaten to limit its diffusion.

Pharmaceutical companies are investing in marketing campaigns tailored to urologists and primary care physicians, emphasizing Avanafil's tolerability. Furthermore, combination therapies and personalized medicine trends may bolster its relevance.

3. Pricing Strategies and Reimbursement

Pricing remains a pivotal driver of market penetration. As a branded drug, Avanafil commands higher prices compared to generics. Insurers' reimbursement policies influence patient access; higher copayments could restrict uptake. In markets where healthcare systems or insurers negotiate prices strongly, generic sildenafil's affordability remains a major advantage.

4. Patient Demographics and Market Penetration

The ED patient demographic is expanding due to increased awareness and aging populations. However, certain subpopulations, such as diabetics or hypertensive patients, may require tailored therapies. Avanafil’s safety profile supports its use in complex comorbidities, offering an opportunity for niche growth.

5. Emerging Therapies and Future Competition

Innovations such as soluble PDE5 inhibitors, gene therapies, and novel non-oral treatments are under clinical development, potentially challenging current PDE5 inhibitors' dominance. Nonetheless, the oral route's convenience sustains PDE5 inhibitors' market share.

Financial Trajectory

1. Revenue Trends and Forecasts

Analysts project moderate revenue growth for Avanafil’s parent companies, contingent upon patent protections, market expansion, and competitive pressures. As of 2022, estimated global sales stood between USD 200–300 million, primarily constrained by the availability of cheaper alternatives.

In the near term (2023–2025), revenues are expected to stabilize or grow marginally, supported by increased adoption in emerging markets and improved awareness among clinicians. Long-term prospects hinge on patent extensions, if applicable, and the entry of generics post-patent expiry.

2. Impact of Patent Expiry on Profitability

Patent expiration typically causes a sharp decline in branded drug revenues—historically 50–70% within 2–3 years post-expiry. Companies often mitigate this decline through patent extensions, formulation patents, or regulatory exclusivities. Effective lifecycle management is essential for maintaining a profitable trajectory.

3. R&D and Line Extension Opportunities

Future investments include formulation innovations (e.g., fast-dissolving tablets), combination products (e.g., ED with benign prostatic hyperplasia), and new delivery methods, which could generate incremental revenue streams and extend market relevance.

4. Strategic Partnerships and Licensing

Strategic alliances with regional distributors or generic manufacturers can facilitate market expansion and mitigate revenue loss from patent expiry. Licensing agreements for biosimilars or novel therapies may diversify revenue portfolios.

Risks and Market Challenges

• Generic Competition: Post-patent expiry, the influx of generics could reduce Avanafil’s market share by up to 80%, compressing profit margins.
• Pricing Pressures: Healthcare payers demand cost-effective solutions, often favoring generics, thereby constraining pricing.
• Market Saturation: Established competitors have entrenched positions, making rapid growth challenging without significant differentiation.
• Regulatory Hurdles: Variability in approval processes across regions may delay market entry.
• Patient Preference Trends: Increasing preference for lifestyle modifications or non-pharmacologic interventions could limit pharmaceutical market growth.

Opportunities for Growth

• Targeting underserved populations with comorbidities and contraindications to older PDE5 inhibitors.
• Expanding into emerging markets where ED treatment remains underpenetrated.
• Developing combination therapies that can command premium pricing.
• Innovating delivery formats to improve patient adherence and satisfaction.

Conclusion

Avanafil's market dynamics are characterized by a balance between its pharmacological advantages and the pervasive influence of generic competition. While current revenues are modest compared to larger PDE5 inhibitors, strategic efforts in niche targeting, formulation enhancements, and geographical expansion can foster incremental growth. The forthcoming patent expiries pose significant challenges, but proactive lifecycle management—including formulation patents, licensing, and new product development—can mitigate decline trajectories.

The financial outlook hinges on patent protections, competitive strategies, and market acceptance. Stakeholders should monitor patent landscapes, healthcare reimbursement policies, and emerging therapies to adapt their strategies effectively.

---

Key Takeaways

• Patent Lifecycle: The impending patent expiries necessitate aggressive lifecycle extension strategies to sustain revenues.
• Market Expansion: Emerging markets provide significant growth opportunities, driven by increasing awareness and healthcare access.
• Differentiation: Avanafil’s pharmacokinetic profile offers a competitive edge, but branding and clinician education are essential.
• Pricing & Reimbursement: Marketability heavily depends on the balance between branded pricing and generic affordability.
• Innovation & Diversification: Developing new formulations, combination products, and exploring novel delivery methods can prolong market relevance.

---

FAQs

1. How does Avanafil compare to other PDE5 inhibitors in terms of efficacy?
Avanafil offers similar efficacy in treating ED as sildenafil and tadalafil, with the added advantage of a rapid onset of action (approximately 15 minutes). Its selectivity for PDE5 minimizes visual side effects common with earlier agents, enhancing tolerability.

2. What is the expected impact of generic Avanafil on its market?
Post-patent expiration, generic versions will significantly reduce Avanafil’s market share and pricing power, likely causing revenues to decline sharply within 1–2 years unless differentiated through formulations or new indications.

3. Are there any recent regulatory developments affecting Avanafil?
No major recent regulatory hurdles have impacted Avanafil's market. Expanding approval in emerging markets continues, but ongoing post-marketing surveillance and regional approval processes are pivotal.

4. What strategies can pharma companies adopt to prolong Avanafil’s market viability?
Strategies include patent extensions, development of new formulations or combination therapies, geographic expansion, targeted marketing, and licensing agreements to delay generic competition.

5. Will new therapies threaten the long-term viability of Avanafil?
Emerging treatments like gene therapy and innovative drug delivery systems could impact the PDE5 inhibitor market, but oral agents' convenience sustains their dominance. Ongoing innovation remains essential for competitiveness.

---

Sources:

[1] Research and Markets. Erectile Dysfunction Therapeutics Market Report, 2022.
[2] IQVIA. Pharmaceutical Market Analysis, 2022.
[3] U.S. Food and Drug Administration. Avanafil (Stendra) Approval Details, 2012.
[4] European Medicines Agency. Spedra (Avanafil) Marketing Authorization, 2013.
[5] GlobalData. Erectile Dysfunction Market Forecast, 2022–2027.