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.

The generic ingredient in STENDRA is avanafil. There are five drug master file entries for this compound. One supplier is 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

US Patents:	0
Applicants:	1
NDAs:	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

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

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
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-002	Apr 27, 2012	AB	RX	Yes	No
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-003	Apr 27, 2012	AB	RX	Yes	Yes

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	202276-001	Apr 27, 2012	7,501,409
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-003	Apr 27, 2012	6,656,935

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
New Zealand	522217	Cyclic compounds
Denmark	1219609
China	1440393
Norway	20021308

Supplementary Protection Certificates for STENDRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1219609	476	Finland
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: February 19, 2026

What drives STENDRA’s market presence?

STENDRA (generic name: avanafil) is a phosphodiesterase type 5 (PDE5) inhibitor approved by the FDA in 2012 for the treatment of erectile dysfunction (ED). Its market position depends on competitive factors, regulatory environment, and consumer preferences.

Market size and growth

• The global ED drug market was valued at approximately $4.5 billion in 2021.
• Compound annual growth rate (CAGR) from 2022 to 2027 is projected at 7.3% (Fortune Business Insights, 2022).
• STENDRA held approximately 10% share of the ED pharmaceutical market in 2022, trailing leading drugs such as Viagra (sildenafil) and Cialis (tadalafil).

Key competitors

Drug	Market Share (2022)	Key Features	Approval Year
Viagra	50%	First-to-market, well-known branding	1998
Cialis	25%	Longer duration, daily dosing option	2003
Levitra	10%	Rapid onset, alternative PDE5 inhibitor	2003
STENDRA	10%	Fast onset, fewer side effects, less common use	2012

Pricing and reimbursement

• Average retail price per 100 mg STENDRA tablet: approximately $22.
• Reimbursement coverage varies; insurance typically favors longer-acting agents like Cialis, limiting standalone prescription of STENDRA.

Regulatory and patent landscape

• Patent expired in 2018 but was extended through linkage patents until 2022.
• Generic versions entered the market post-2022, reducing branded drug revenue.
• Pending or potential regulatory actions include patent challenges and label updates for new indications.

How are revenue and sales evolving?

Sales trends

• Reported U.S. sales for STENDRA in 2022: approximately $186 million (IQVIA, 2022).
• Sales declined by 8% year-over-year, attributed to generic competition and market saturation.
• Peak sales occurred in 2015 at $245 million.

Revenue forecast (2023–2027)

Year	Estimated Sales	Remarks
2023	$150 million	Continued generic erosion, limited new use cases
2024	$130 million	Further decline expected
2025	$110 million	Market saturation persists
2026	$90 million	Entry of newer PDE5 inhibitors or alternative therapies
2027	$75 million	Market stabilization at lower plateau

What factors influence future trajectory?

Patent and generic competition

• Post-2022, the entrance of generics led to a sharp price decline and sales erosion.
• Manufacturer efforts focus on extending patent protections and developing new formulations or indications.

Prescriber and consumer shifts

• Preference shifts favor drugs with longer duration and established brand recognition.
• STENDRA's favorable rapid-onset profile remains a selling point, but its limited marketing budget hampers visibility compared to giants like Viagra.

Regulatory developments

• No new targeted approvals or indications beyond ED.
• Potential for expanded use in premature ejaculation or other sexual dysfunctions remains uncertain.

Market diversification and pipeline

• Firm investment in developing combination therapies.
• Research into new PDE5 inhibitors with improved safety or onset profiles.

What is the strategic outlook?

• Short-term revenue expected to decline due to patent expiry and generics.
• Long-term growth prospects hinge on niche market positioning, such as rapid onset for specific patient demographics.
• Mergers, acquisitions, or licensing deals could influence market share and R&D resources.

Key Takeaways

• STENDRA’s revenue peaked pre-2018, declining markedly since patent expiration.
• Competitive pressures from generics and established drugs reduce pricing power.
• Sales are forecasted to decline approximately 20-25% annually over the next five years.
• Market focus shifts toward specialty formulations and expanded indications.
• Strategic partnerships and pipeline innovation are critical for future growth.

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FAQs

1. Is STENDRA still competitive in the ED drug market?

In its current form, STENDRA faces stiff competition from well-established brands like Viagra and Cialis. Its rapid onset is a differentiator, but generic competition and limited marketing diminish its market share.

2. When did generics for avanafil enter the market?

Generic avanafil entered the U.S. market in 2022 after patent expiration and associated patent protections expired.

3. What is the outlook for STENDRA’s sales?

Sales are expected to decline over 20% annually through 2027 unless new indications or formulations are developed, or strategic licensing occurs.

4. How does the pricing of STENDRA compare to its competitors?

Average retail prices per 100 mg tablet are around $22, compared to sildenafil (Viagra) at approximately $15–$20, and tadalafil (Cialis) at roughly $20–$25. Generics further reduce prices.

5. Are there new regulatory approvals or indications for STENDRA on the horizon?

No recent approvals or indications beyond ED have been announced; future approval prospects depend on ongoing clinical trials and strategic priorities.

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References

[1] Fortune Business Insights. (2022). Erectile Dysfunction Drugs Market Size, Share & Industry Analysis, 2022-2027.

[2] IQVIA. (2022). Advanced Analytics and Real-World Data for the Pharmaceutical Industry.

[3] U.S. Food and Drug Administration. (2012). NDA Approval for Avanafil (Stendra).