STENDRA Drug Patent Profile

Which patents cover Stendra, and when can generic versions of Stendra launch?

Stendra is a drug marketed by Vivus Llc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in STENDRA is avanafil. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the avanafil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Stendra

A generic version of STENDRA was approved as avanafil by HETERO LABS LTD V on June 14^th, 2024.

Summary for STENDRA

International Patents:	41
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	6
Patent Applications:	2,378
Drug Prices:	Drug price information for STENDRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for STENDRA
What excipients (inactive ingredients) are in STENDRA?	STENDRA excipients list
DailyMed Link:	STENDRA at DailyMed

See drug prices for STENDRA

Recent Clinical Trials for STENDRA

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

Sponsor	Phase
VIVUS, Inc.	Phase 4
VIVUS, Inc.	Phase 3

See all STENDRA clinical trials

Pharmacology for STENDRA

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Paragraph IV (Patent) Challenges for STENDRA

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 STENDRA

STENDRA is protected by one US patents and one FDA Regulatory Exclusivity.

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	202276-001	Apr 27, 2012	AB	RX	Yes	No			Y	Y
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012	AB	RX	Yes	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			Y	Y

Expired US Patents for STENDRA

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

EU/EMA Drug Approvals for STENDRA

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 STENDRA

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

Country	Patent Number	Title	Estimated Expiration
China	1264574
Australia	8444401
China	102584799
World Intellectual Property Organization (WIPO)	0220058

Supplementary Protection Certificates for STENDRA

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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: STENDRA (Avanafil)

Last updated: July 27, 2025

Introduction

Stendra (generic name: avanafil) is a PDE5 inhibitor approved by the FDA in 2012 for the treatment of erectile dysfunction (ED). Positioned as a fast-acting, prescriber-preferred option within a substantial and growing market, Stendra’s market dynamics and financial trajectory are shaped by regulatory, competitive, and consumer behavior factors, alongside evolving healthcare policies and technological advancements.

Market Overview

The global erectile dysfunction market is projected to reach approximately USD 4.3 billion by 2027, expanding at a CAGR of over 7% (via Grand View Research). This growth is propelled by increasing awareness, aging populations, and the rising prevalence of comorbidities such as cardiovascular disease and diabetes, which are linked to ED. While Viagra (sildenafil) and Cialis (tadalafil) dominate market share, newer alternatives like Stendra have carved niche positions due to distinct pharmacokinetic profiles.

Market Dynamics Influencing Stendra

1. Competitive Landscape and Differentiation

Stendra’s primary competitive advantage lies in rapid onset of action, with onset times as quick as 15 minutes and a favorable side-effect profile. These characteristics target a subset of consumers seeking spontaneous sexual activity, positioning Stendra as a premium, convenient alternative to older PDE5 inhibitors. However, competition remains fierce, with Pfizer's Viagra and Eli Lilly's Cialis dominating sales due to established brand recognition and extensive physician familiarity.

2. Regulatory and Prescribing Trends

Since its launch, Stendra has successfully navigated evolving regulatory terrains, benefiting from clear labeling that emphasizes faster efficacy. Physician prescribing habits are influenced by clinical guidelines, which increasingly recommend tailored therapies based on patient needs, favoring drugs like Stendra that support "on-demand" use with quick action.

3. Reimbursement and Pricing Dynamics

Pricing strategies critically impact market penetration. Stendra's premium positioning allows for higher per-unit prices; however, reimbursement challenges, insurance coverage limits, and cost-pricing strategies influence patient access. Payers' preferred formularies tend to favor established brands unless compelling evidence of superior efficacy or safety is available to justify premium pricing.

4. Consumer Preferences and Awareness

Patient awareness campaigns and direct-to-consumer advertising have significantly elevated the profile of ED treatments. Stendra’s marketing emphasizes convenience and rapid onset, appealing to younger demographics and new users. Nonetheless, stigma and reluctance to seek treatment remain barriers in many markets, impacting overall demand.

5. Patent and Patent Expirations

Although Pfizer's original patents for sildenafil expired in 2013, generics flooded the market, reducing brand dominance. For Stendra, patent protection extends until at least 2024-2025, providing a window of market exclusivity that supports revenue growth. Future patent challenges and potential biosimilar entries could dampen profitability.

Financial Trajectory Outlook

1. Revenue Growth Projections

Since its launch, Stendra has experienced steady but modest growth, largely confined to specialized urology clinics and specialty pharmacies. Analysts forecast revenue to reach USD 200-300 million annually by 2025, contingent upon market expansion strategies and increased prescriber acceptance.

2. Market Penetration Strategies

Pfizer’s approach includes expanding into new geographical markets—particularly Asia-Pacific and Europe—where awareness of ED treatments is rising. Additionally, deploying patient assistance programs and engaging healthcare providers with data emphasizing superior rapid onset is critical to boosting prescribing rates.

3. R&D and Lifecycle Management

Future revenue hinges on lifecycle management through new formulations (e.g., long-acting versions or combination therapies), brand extensions, or indications. Currently, no significant pipeline modifications are publicly announced, but patient-centric innovations could sustain market relevance.

4. External Economic Factors

Healthcare policy reforms, especially those aimed at reducing drug costs or altering insurance coverage structures, could impose pricing pressures. Conversely, if emerging data underscores Stendra’s superior efficacy and safety, pricing power could bolster revenue growth.

Risks and Opportunities

Risks

• Patent expiration and generic entry threaten price erosion.
• Competitive advancements, such as next-generation ED treatments, could reduce market share.
• Regulatory challenges related to off-label use or safety profiles.

Opportunities

• Expanding into broader sexual health markets.
• Strategic alliances with telemedicine providers to facilitate increased access.
• Harnessing digital health tools for patient engagement and adherence.

Conclusion

Stendra’s market dynamics are characterized by a combination of competitive differentiation and external market forces. Its future financial trajectory depends on effective lifecycle management, expansion strategies, and navigating healthcare policy landscapes. While facing stiff competition and patent challenges, Stendra's unique pharmacokinetic profile and consumer appeal provide avenues for growth within the expanding ED treatment market.

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Key Takeaways

• Stendra’s rapid onset affords competitive differentiation but must contend with established brands and generics.
• Revenue growth prospects hinge on geographic expansion, marketing, and lifecycle innovations.
• Patent exclusivity until 2024–2025 provides a strategic window but necessitates aggressive market share capture.
• Reimbursement policies and consumer awareness substantially impact access and uptake.
• Long-term success depends on adapting to regulatory landscapes and leveraging digital health innovations.

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Frequently Asked Questions (FAQs)

1. How does Stendra differentiate itself from other PDE5 inhibitors?
Stendra offers a faster onset of action, approximately 15 minutes, and a shorter duration relative to Cialis, making it suitable for spontaneous sexual activity, which appeals to certain patient demographics.

2. When does patent protection for Stendra expire, and what are the implications?
Patent protection in the US is expected to last until 2024–2025. Expiry may lead to generic competition, pressuring pricing and potentially reducing revenue.

3. What market segments are most receptive to Stendra?
Younger men seeking quick, on-demand therapy and those intolerant to side effects of other ED medications are primary targets. Also, healthcare providers favoring personalized treatment plans are influence points.

4. How has the regulatory environment affected Stendra’s market trajectory?
Clear labeling emphasizing its rapid onset has supported prescriber confidence. Regulatory clarity reduces risk, but future labeling or safety concerns could impact market acceptance.

5. What strategies can Pfizer employ to maximize Stendra's market share?
Expanding geographic presence, emphasizing unique benefits in marketing, engaging digital and telehealth channels, and pursuing lifecycle innovations can enhance market penetration.

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References

[1] Grand View Research, "Erectile Dysfunction Market Size, Share & Trends Analysis Report," 2022.
[2] U.S. Food & Drug Administration, "FDA Approval for Stendra (Avanafil)," 2012.
[3] Pfizer, "Stendra (Avanafil) Product Information," 2023.
[4] IQVIA, "Pharmaceutical Market Data," 2022.
[5] MarketWatch, "Erectile Dysfunction Market Outlook," 2022.