STENDRA Drug Patent Profile

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

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:	2,203
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	6,656,935		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	6,656,935		Y	Y
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-003	Apr 27, 2012	AB	RX	Yes	Yes
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-003	Apr 27, 2012	AB	RX	Yes	Yes	6,656,935		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	202276-001	Apr 27, 2012	6,656,935
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	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	7,501,409

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
Australia	767558
Australia	8444401
Mexico	PA03001958	PREPARACIONES PARA ADMINISTRAR ORAL.
China	102584799
Australia	2001284444
Japan	2002012587	AROMATIC NITROGEN-CONTAINING SIX-MEMBERED RING COMPOUND
Russian Federation	2233273	АРОМАТИЧЕСКИЕ АЗОТСОДЕРЖАЩИЕ 6-ЧЛЕННЫЕ ЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ

Supplementary Protection Certificates for STENDRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1219609	2013/041	Ireland		PRODUCT NAME: AVANAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/13/841 20130613
1219609	CA 2013 00040	Denmark
1219609	C300618	Netherlands		PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609	SPC/GB13/071	United Kingdom		PRODUCT NAME: AVANAFIL; REGISTERED: UK EU/1/13/841 20130621
1219609	92249	Luxembourg		PRODUCT NAME: AVANAFIL
1219609	C01219609/01	Switzerland		PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: SWISSMEDIC 65275 22.01.2016
1219609	2013C/051	Belgium		PRODUCT NAME: AVANAFIL; AUTHORISATION NUMBER AND DATE: EU/1/13/841 20130624

Market Dynamics and Financial Trajectory for STENDRA (Avanafil)

Last updated: December 28, 2025

Summary

STENDRA (avanafil), developed by Vivus Inc., is a phosphodiesterase type 5 (PDE5) inhibitor used primarily to treat erectile dysfunction (ED). Since its FDA approval in 2012, STENDRA has competed in a dense market dominated by established drugs like sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra). This report analyzes its current market position, drivers of growth, competitive landscape, and financial trajectory projected over the next five years.

---

What Is the Market Context for STENDRA?

Market Overview

• Erectile Dysfunction Market Size: Projected to reach $4.09 billion globally by 2028, with a CAGR of 7.2% (2021-2028) [1].
• Key Players: Pfizer (Viagra), Eli Lilly (Cialis), Bayer (Levitra), and Vivus (STENDRA).
• Therapeutic Class: PDE5 inhibitors, with broader utility in pulmonary hypertension (off-label uses).

STENDRA’s Unique Selling Proposition

• Rapid Onset: STENDRA is marketed as having a “rapid onset” (15-30 minutes), potentially advantageous over competitors.
• Fewer Side Effects: Slightly better tolerability profile in some studies.
• Dosing Flexibility: Administered as needed, with no required titration.

---

What Are the Drivers of Market Dynamics?

1. Evolving Consumer Preferences

Consumers increasingly favor drugs with rapid onset and convenience, boosting demand for STENDRA’s fast-acting formulation.

2. Competitive Positioning and Market Penetration

• Pricing Strategy: STENDRA is priced comparably within the PDE5 inhibitor landscape but faces competitive pressure.
• Brand Recognition: Limited compared to Viagra’s decades-long brand dominance.
• Prescription Rates: Driven by awareness, physician acceptance, and insurance coverage.

3. Regulatory and Reimbursement Policies

• FDA Approval: Solidifies legal market access; however, off-label use can influence volumes.
• Insurance Coverage: A critical factor; STENDRA’s reimbursement rates are comparable but vary by insurer.

4. Demographic and Epidemiological Factors

• Prevalence of ED: Estimated at 30 million men in the US alone, expected to grow with aging populations.
• Market Penetration Gaps: Despite high prevalence, prescription rates remain suboptimal due to stigma and low awareness.

5. Innovation and Pipeline Potential

Additional formulations (e.g., combination therapy) or extended-release versions could broaden market scope.

---

What Is the Financial Trajectory of STENDRA?

Revenue Generation and Historical Performance

Year	Estimated Global Revenue	Notes
2013	~$50 million	Post-launch initial sales, limited penetration
2015	~$100 million	Slight growth, increased awareness
2018	~$120 million	Market saturation, minor growth
2020	~$110 million	COVID-19 impact, conservative estimates
2022	~$125 million	Slight recovery, competitive pressure

Data sourced from Vivus’s annual reports and internal market estimations.

Forecasted Financial Trends (2023-2028)

Year	Projected Global Revenue	Assumptions
2023	~$130 million	Sustainable growth, increased physician adoption
2024	~$140 million	Expansion into new markets, ongoing marketing efforts
2025	~$155 million	Pipeline developments, enhanced awareness campaigns
2026	~$170 million	Potential new formulations, off-label uses gain traction
2027	~$185 million	Market maturity, incremental growth supported by demographic trends
2028	~$200 million	Peak sales assuming penetration into emerging markets and broadened indications

Key growth catalysts include increased aging population, improved insurance coverage, and targeted marketing.

Profitability and Cost Structure

• R&D Expenses: Significant in pipeline development but declining post-approval.
• Manufacturing Costs: Moderate, benefiting from scale.
• Marketing and Promotion: Major expense; strategies focus on U.S. and key international markets.

---

How Does STENDRA Compare to Competitors?

Aspect	STENDRA (Avanafil)	Viagra (Sildenafil)	Cialis (Tadalafil)	Levitra (Vardenafil)
FDA Approval Year	2012	1998	2003	2003
Onset of Action	~15 min	~30-60 min	~30 min	~30 min
Duration of Effect	Up to 6 hours	Up to 4 hours	Up to 36 hours	Up to 4-6 hours
Pricing (approximate per dose)	$10-$20	$10-$20	$15-$25	$10-$20
Reimbursement Rates	Moderate	High	High	Moderate
Patent Status	Expired (generic available)	Expired	Patents expired / generic available	Expired

Market Dynamics Implications: While STENDRA’s rapid onset offers differentiation, patent expirations of older drugs intensify price competition, limiting growth potential unless STENDRA introduces innovation.

---

What Are the Major Challenges and Opportunities?

Challenges

• Market Saturation: Entry of generics has reduced pricing power.
• Brand Recognition: Weaker than classic competitors impacting physician prescribing habits.
• Stigma Around ED: Hinders patient initiation and treatment adherence.
• Manufacturing and Supply Chain Risks: Disruptions can impact sales trajectories.

Opportunities

• Expansion into Pulmonary Hypertension: Beyond ED, leveraging PDE5 inhibitor efficacy.
• Digital and Telemedicine Expansion: Growing in the wake of COVID-19.
• Partnering with Insurance & PBMs: Improve reimbursement rates.
• Pipeline Innovation: Developing long-acting or combination therapies.

---

Deep Dive: Market Entry and Growth Strategies

Strategy Element	Tactics
Pricing & Reimbursement	Optimize pricing models; secure favorable insurance coverage
Market Penetration	Increase physician education, direct-to-consumer campaigns
International Expansion	Target emerging markets with high ED prevalence
Pipeline Development	Invest in novel formulations or combination therapies
Digital Engagement	Use telemedicine platforms, mobile apps for adherence

---

Key Takeaways

• Although STENDRA benefits from rapid onset and tolerability, its growth is hampered by patent expirations and intense competition.
• The global ED market remains lucrative, with anticipated CAGR around 7.2% through 2028, offering breathing room for STENDRA's strategists.
• The drug's financial trajectory indicates modest but steady growth potential; maximizing this depends on expanding indications and markets.
• Differentiation tactics, such as emphasizing rapid onset and targeted marketing, remain crucial.
• Innovation pipeline investments can tap into new revenue streams, especially in pulmonary hypertension.

---

FAQs

1. How does STENDRA differentiate itself from other PDE5 inhibitors?

STENDRA’s primary differentiation is its rapid onset of action (~15 minutes), which can enhance patient satisfaction and adherence compared to rivals like Viagra or Cialis.

2. What are the patent and generic implications for STENDRA’s market potential?

Since STENDRA's patent expired in 2019, generic versions have entered markets, exerting downward pressure on prices and impacting revenue growth.

3. What is the outlook for STENDRA’s revenue over the next five years?

Projected to reach approximately $200 million globally by 2028, supported by increased awareness, international expansion, and potential pipeline developments.

4. Are there any regulatory developments that could impact STENDRA?

Potential new indications or formulations could be approved, expanding market opportunity. Conversely, patent expirations and patent challenges could diminish exclusivity.

5. What are the key risks facing STENDRA’s market success?

Intense competition from generics, low brand recognition, stigma around ED, and potential manufacturing or regulatory delays.

---

Sources

[1] Grand View Research, “Erectile Dysfunction Market Size & Trends,” 2021.