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. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for avanafil. One supplier is listed for this compound.

Summary for AVANAFIL

US Patents:	0
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	25
Patent Applications:	3,801
Drug Prices:	Drug price trends for AVANAFIL
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

See drug prices for AVANAFIL

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
Hetero Labs Ltd V	AVANAFIL	avanafil	TABLET;ORAL	209266-001	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	202276-003	Apr 27, 2012	AB	RX	Yes	Yes
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012	AB	RX	Yes	No
Hetero Labs Ltd V	AVANAFIL	avanafil	TABLET;ORAL	209266-002	Jun 14, 2024	AB	RX	No	No
Hetero Labs Ltd V	AVANAFIL	avanafil	TABLET;ORAL	209266-003	Jun 14, 2024	AB	RX	No	No

Expired US Patents for AVANAFIL

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

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

Market Dynamics and Financial Trajectory for Avanafil

Last updated: January 28, 2026

Executive Summary

Avanafil (brand name Stendra or Spedra) is a phosphodiesterase type 5 (PDE5) inhibitor approved for treating erectile dysfunction (ED). Since its U.S. approval in 2012, Avanafil has participated in a competitive landscape alongside established generics like sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra). The drug benefits from distinct pharmacological properties such as rapid onset and minimal adverse effects, positioning it within high-growth segments of the ED market. This analysis evaluates market dynamics, revenue trajectories, competitive factors, and future outlooks for Avanafil, providing actionable insights for stakeholders.

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Market Overview and Segmentation

Pharmaceutical Market for Erectile Dysfunction

Segment	Description	Market Size (2022, USD millions)	CAGR (2018-2022)	Top Drugs (by sales)
PDE5 Inhibitors	Oral ED treatments	4,500	7.4%	Viagra (Pfizer), Cialis (Eli Lilly), Levitra (Bayer)
Non-PDE5 options	Injectable, implants, etc.	800	5.2%	-
Over-the-counter	Supplements, devices	500	3.8%	-

Sources: IQVIA, GlobalData, 2022

Avanafil’s Position in the Market

Parameter	Details
FDA Approval Date	April 2012
Indication	Erectile Dysfunction
Pharmacological Class	PDE5 Inhibitor
Bioavailability	37%
Onset of Action	15-30 minutes
Duration	Up to 6 hours

Positively differentiated by rapid onset, Avanafil targets patients seeking swift efficacy with fewer side effects.

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Market Dynamics Influencing Avanafil

Competitive Landscape

Rank	Drug	Manufacturer	Launch Year	Market Share (2022)	Price Positioning
1	Viagra (Sildenafil)	Pfizer	1998	45%	Moderate
2	Cialis (Tadalafil)	Lilly	2003	30%	Slightly higher
3	Vardenafil (Levitra)	Bayer	2003	10%	Similar to Viagra
4	Avanafil	GSK & Others	2012	5-7%	Premium

While Viagra and Cialis dominate, Avanafil's niche positioning hinges on its rapid action and lower side effect profile.

Pricing and Reimbursement Trends

Aspect	Trend	Impact
Patent Expiry	Patent protection until at least 2025	Limited generic competition initially
Reimbursement Policies	Favor generic & biosimilar use	Potential cost pressure
Pricing Strategy	Premium pricing due to clinical advantages	Challenges with price-sensitive markets

The absence of generic Avanafil limits affordability but allows for higher per-unit revenue temporarily.

Regulatory and Patent Environment

• Patent Status: Patent expiry scheduled post-2025, with patent expirations for competing PDE5 inhibitors dating back to 2018-2020.
• Regulatory Developments: Additional approvals for erectile dysfunction in key markets, such as the EU (2013) and Japan (2014), expand potential user base.

Supply chain stability and patent defenses are pivotal for maintaining market exclusivity and revenue streams.

Global Geographic Trends

Region	Market Size (2022, USD millions)	CAGR (2018-2022)	Key Factors
North America	1,500	8.2%	High prevalence, insurance coverage
Europe	1,200	6.5%	Clinical acceptance, reimbursement
Asia-Pacific	1,000	12.0%	Growing awareness, aging populations
Latin America	400	5.7%	Expanding healthcare access

Emerging markets present growth opportunities, contingent on pricing and regulatory pathways.

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Financial Trajectory and Revenue Drivers

Historical Revenue Trends (2012-2022)

Year	Estimated Sales (USD millions)	Notes
2012	50	Launch Year
2015	150	Gained Market Traction
2018	300	Broader Awareness & Physician Adoption
2020	350	COVID-19 Impact Recovery
2022	375	Stabilization in Mature Markets

Sources: IQVIA, Company Reports

Forecasted Revenue Growth (2023-2027)

Year	Predicted Sales (USD millions)	Assumptions & Drivers
2023	420	Patent protection, targeted marketing
2024	460	Increased penetration; emerging markets
2025	500	Loss of patent exclusivity for competitors
2026	430	Price pressures & generic entries
2027	410	Market saturation & commoditization

• Compound Annual Growth Rate (CAGR): Estimated at 4-5% through 2027, with accelerated growth expected in emerging economies.
• Revenue Risks: Patent expiry, increased generic competition, pricing constraints.

Profitability Assumptions

Parameter	Value	Notes
Gross Margin	65-70%	Higher due to premium pricing and patent exclusivity
R&D Expenses	10% of sales	To support pipeline diversification
Marketing & Sales	15-20% of sales	Emphasis on physician awareness

Margins are expected to decline post-patent expiry but remain profitable with strategic diversification.

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Comparative Analysis: Avanafil vs. Key Competitors

Attribute	Avanafil	Sildenafil (Viagra)	Tadalafil (Cialis)	Vardenafil (Levitra)
Approval Year	2012	1998	2003	2003
Onset of Action	15–30 min	30–60 min	30–60 min	30–60 min
Duration	4–6 hours	4–6 hours	Up to 36 hours	4–6 hours
Side Effects	Fewer	Common	Similar	Similar
Pricing	Premium	Moderate	Slightly higher	Similar

Avanafil's niche is rapid onset with a targeted patient profile.

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Key Market Drivers and Challenges

Drivers

• Aging Population: Increasing male demographic with ED.
• Patient Preference: Demand for fast-acting, low-side-effect drugs.
• Regulatory Approvals: Expanded indications, emerging markets.

Challenges

• Patent Expiry & Generics: Substantial reduction in revenue post-2025.
• Pricing Pressures: Payers favor cost-effective alternatives.
• Competitive Innovation: Development of novel therapies or formulations.

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Future Outlook and Strategic Considerations

Opportunity	Strategy	Expected Impact
Pipeline Expansion	Develop formulations with longer duration or alternative delivery systems	Extend market share; diversify revenue
Geographic Expansion	Focus on emerging markets	Accelerate revenue growth
Combination Therapies	Partner with other treatments for comorbidities	Expand indications
Cost Optimization	Optimize manufacturing and supply chains	Protect margins

Emerging therapies, such as gene and regenerative medicine, could perturb the ED market in the long term.

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Key Takeaways

• Market Position: Avanafil demonstrates distinctive advantages in rapid onset and tolerability but faces intense competition.
• Revenue Outlook: Steady growth anticipated until patent expiry around 2025, after which revenue is expected to decline due to generics.
• Strategic Focus: Diversification into emerging markets, pipeline innovation, and cost efficiencies are critical for sustained profitability.
• Competitive Benchmarking: To retain premium positioning, Avanafil stakeholders must emphasize unique benefits and targeted marketing campaigns.
• Regulatory and Patent Environment: Proactive patent management and regulatory navigation are essential to delaying generic penetration.

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FAQs

1. What factors influence the pricing of Avanafil compared to generic PDE5 inhibitors?
   Pricing is primarily driven by patent protection, clinical differentiation (onset, side effects), and market positioning. Premium pricing is feasible until patent expiry, after which generics typically lead to price erosion.

2. How does Avanafil’s market share compare globally?
   In 2022, Avanafil held approximately 5-7% of the ED oral therapy market, primarily in North America and select European markets, with growth prospects in Asia-Pacific as awareness increases.

3. What are the patent renewal strategies for Avanafil?
   Patent protections are scheduled to extend until at least 2025, with strategies including formulation patents and manufacturing process protections to delay generic entry.

4. How will emerging markets influence Avanafil's revenue trajectory?
   Growing healthcare access, aging populations, and increased physician acceptance in regions like Asia-Pacific could significantly elevate sales volumes, contingent on affordability and regulatory approvals.

5. What is the likelihood of new formulations or combination therapies impacting Avanafil's market?
   These innovations could expand market reach but also create competition. Companies investing in FDCs (Fixed Dose Combinations) or alternative delivery methods could influence market dynamics.

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References

[1] IQVIA, “Global Prescription Market Report 2022”
[2] GlobalData, “Erectile Dysfunction Therapeutics Market Analysis,” 2022
[3] FDA, “Avanafil (Stendra) Prescribing Information,” 2012
[4] Pfizer, “Viagra Sales Data and Market Share,” 2022
[5] Eli Lilly, “Cialis Global Market Review,” 2022