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:	2,264
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	202276-003	Apr 27, 2012	7,501,409
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	6,656,935
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-001	Apr 27, 2012	7,501,409
Vivus Llc	STENDRA	avanafil	TABLET;ORAL	202276-002	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
Argentina	025668	COMPUESTOS CICLICOS DE 6 MIEMBROS CONTENIENDO NITRoGENO AROMÁTICOS.
Austria	358670
Australia	2001241142
Australia	4114201
Australia	7311800

Supplementary Protection Certificates for STENDRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1219609	92249	Luxembourg		PRODUCT NAME: AVANAFIL
1219609	CA 2013 00040	Denmark
1219609	C300618	Netherlands		PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609	13C0050	France		PRODUCT NAME: AVANAFIL; REGISTRATION NO/DATE: EU/1/13/841 20130621
1219609	1390047-7	Sweden		PRODUCT NAME: AVANAFIL; REG. NO/DATE: EU/1/13/841 20130621

STENDRA (avanafil) market dynamics and financial trajectory: sales trends, pricing pressure, exclusivity and generic risk

Last updated: July 22, 2026

STENDRA (avanafil) is a U.S.-launched PDE5 inhibitor with limited scale versus category leaders (Viagra, Cialis, Levitra) and continuing pricing/volume pressure. Financial trajectory in the U.S. is constrained by (1) the product’s late entrant status, (2) competition from entrenched branded PDE5 inhibitors and generics, and (3) a thin U.S. exclusivity/patent moat relative to market incumbents, which increases the odds of earlier generic normalization. The near-term market dynamic is dominated by category substitution and payer-driven step edits rather than molecule-specific differentiation.

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How has STENDRA performed commercially in the U.S. since launch?

Bottom line: STENDRA’s revenue trajectory tracks a niche profile for a late-arriving branded PDE5 inhibitor, with sales dependent on episodic demand rather than sustained brand expansion.

U.S. launch economics and category substitution

• STENDRA (avanafil) entered a market where patients and prescribers were already habituated to:
  • tadalafil (Cialis) and sildenafil (Viagra) as first-choice options,
  • and vardenafil (Levitra) among those seeking alternative onset/duration profiles.
• PDE5 prescribing is heavily influenced by:
  • formulary placement (often preferred drug lists),
  • out-of-pocket cost,
  • and “therapeutic interchange” patterns by payers.
• This dynamic typically limits the ceiling for a smaller branded PDE5 entrant unless supported by aggressive contracting or a distinctive payer value proposition.

What typically drives STENDRA volume

For PDE5 inhibitors, monthly script volume depends on:

• patient switching between agents due to tolerability, onset preference, and insurance coverage,
• replenishment cycles tied to relationship and demand patterns rather than chronic daily use,
• physician sampling and early brand familiarity.

For a late branded entrant, these drivers tend to produce:

• initial uptake but limited sustained share,
• slow conversion from branded category leaders.

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What market dynamics are shaping STENDRA demand versus Viagra, Cialis, and Levitra?

Bottom line: Competitive pressure is structural. STENDRA competes in a crowded PDE5 inhibitor field where generics and payer preference compress margins.

Pricing and payer behavior

• Medicare Part D and commercial formularies often place sildenafil/tadalafil generics as lower-cost preferred options.
• Branded PDE5 inhibitors can remain on formularies but usually under tighter:
  • tiering,
  • prior authorization,
  • quantity limits,
  • or step therapy.

These tools reduce incremental demand for a non-preferred brand and can accelerate switching to generics.

Prescriber behavior and differentiation limits

STENDRA is differentiated on:

• avanafil’s onset characteristics and dosing flexibility,
• side-effect profile and patient tolerance.

In practice, differentiation is often less decisive than:

• “first available low-cost option,”
• familiarity,
• and coverage.

That limits competitive gains unless STENDRA becomes the preferred option under payer contracts.

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What is the U.S. exclusivity and patent expiration risk for STENDRA (avanafil)?

Bottom line: U.S. generic normalization risk increases as relevant patent protections and any regulatory exclusivities erode, and as Paragraph IV or other generic pathways become viable.

How exclusivity typically maps to market share

STENDRA’s revenue ceiling is usually governed by two legal lanes:

1. Regulatory exclusivity (FDA-related exclusivity blocks for new active ingredients or new clinical claims, if applicable).
2. Patent estate (composition, formulations, methods of use, and manufacturing patents listed in the FDA Orange Book).

Once these barriers decline:

• generic sildenafil/tadalafil market substitutes remain widely available,
• and a generic avanafil can directly pressure STENDRA pricing and volume.

Key commercial implication

Even if an avanafil generic is not immediately launched, payer step therapy can still erode brand economics. When generics enter, branded PDE5 pricing commonly drops to maintain shelf placement.

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What is the Orange Book status of STENDRA and what patents are likely to matter?

Bottom line: The Orange Book defines the legal landscape for generic avanafil in the U.S. Patent-listed claims drive Paragraph IV filing decisions.

Patent types that usually matter for PDE5 branded products

For a PDE5 drug, the most commercially decisive patents typically include:

• composition of matter (avanafil itself),
• solid-state forms and polymorphs,
• formulation patents tied to tablet composition and release,
• and method-of-use claims (if any) tied to specific dosing regimens.

Featured snippet: what to check in the Orange Book

• Active ingredient listing: avanafil
• Dosage forms: tablets (strength-specific listings)
• Patent list for each NDA
• Patent expiration dates
• Whether patents are expired or still listed as of the current Orange Book publication.

(Orange Book listing details are product- and NDA-specific; this report does not include Orange Book line-item listings because they require live Orange Book data extraction to be accurate.)

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How many ANDA or Paragraph IV challenges affect STENDRA, and when do they matter?

Bottom line: Paragraph IV challenges are the main catalyst for earlier generic market entry when inventors still hold listed patents but challengers can carve around or invalidate claims.

How market timing is set by litigation

If a generic challenger files a Paragraph IV ANDA:

• FDA must be notified of the statutory dispute,
• litigation triggers potential 30-month stay (if applicable),
• settlement can lead to:
  • delayed launch dates,
  • agreed licensing terms,
  • or non-infringement/invalidity resolution with faster entry if patents fall.

Commercial effect of a likely generic entry

When avanafil generics enter:

• brand price support typically ends within months,
• payers rapidly move to lowest-cost options,
• market share shifts to the generic and to interchangeable category options.

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What settlement or licensing dynamics are typical for PDE5 inhibitor patent disputes like STENDRA?

Bottom line: For PDE5 inhibitors, settlement agreements usually aim to:

• preserve a limited branded launch window by date and territory,
• prevent “design-around” entry,
• set supply or royalty terms during a defined exclusivity period.

Litigation outcome drivers that influence settlement

• strength of composition/formulation claims,
• feasibility of design-around (different polymorph/formulation or manufacturing),
• timeliness and procedural posture (Markman, summary judgment schedules),
• damages models linked to expected generic adoption.

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What is the biosimilar risk for STENDRA?

Bottom line: STENDRA is a small-molecule drug, not a biologic. Biosimilar risk is not applicable.

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How does STENDRA’s formulation and dosing affect market adoption and patent coverage?

Bottom line: Tablet strengths and release characteristics can influence both prescribing preference and the scope of formulation protection.

Dosing structure and patient switching

• A PDE5 inhibitor’s dosing flexibility affects adherence and perceived spontaneity.
• In competitive settings, switching can occur when:
  • onset is perceived as faster,
  • duration better matches the patient’s planned activity,
  • tolerability is improved.

Formulation patents as a barrier

Formulation IP can delay “non-infringing” generic entry if patents cover:

• tablet composition,
• specific excipients,
• solid-state properties,
• dissolution/release profiles.

Once those patents expire, generic market entry becomes more feasible, compressing revenue.

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How does STENDRA compare with competing PDE5 inhibitors on commercial positioning?

Bottom line: STENDRA’s market position is a “second-tier branded” profile relative to leaders with broader formulary access and entrenched prescriber behavior.

Comparative positioning framework (market mechanics)

• Cialis (tadalafil): longer duration, strong payer comfort, high switching stickiness.
• Viagra (sildenafil): strong historical brand familiarity, broad generic availability.
• Levitra (vardenafil): competes on onset and tolerability niche.
• STENDRA (avanafil): late entrant; more limited share drivers and narrower payer adoption.

The commercial constraint is not clinical superiority alone; it is channel access:

• formulary status,
• reimbursement thresholds,
• and price-to-generics parity.

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What generic entry risks exist for STENDRA and how fast would they hit revenue?

Bottom line: Generic entry risk is concentrated in a window when:

• avanafil-specific patent barriers fall,
• and an ANDA becomes legally and technically ready for launch.

Revenue hit profile for branded PDE5 inhibitors

A typical branded-to-generic transition produces:

• sharp initial volume loss as payers move to generics,
• price compression and margin erosion from contracted pricing,
• reduced brand marketing ROI because incremental scripts become hard to secure.

If the generic launches into an already commoditized PDE5 class, adoption can be fast.

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How would an ANDA launch scenario likely play out for STENDRA?

Bottom line: A generic avanafil launch would likely accelerate channel switching and reduce the brand’s ability to sustain premium pricing.

Common launch-and-coverage sequence

• Generic enters with established bioequivalence labeling.
• PBMs update preferred formularies and tier placement.
• Prescribers switch by default when patients are cost sensitive.
• Remaining branded use becomes limited to:
  • patients stable on brand,
  • insurer exceptions,
  • or physician preference with adequate reimbursement.

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Key Takeaways

• STENDRA’s financial trajectory reflects niche branded scaling in a PDE5 inhibitor market dominated by older incumbents and generic pricing pressure.
• The primary market dynamic is substitution through formularies and step therapy rather than molecule-driven share capture.
• Generic entry risk is a function of avanafil-specific U.S. Orange Book patent barriers and any Paragraph IV challenges; once those weaken, revenue compression typically follows quickly.
• Biosimilar risk does not apply because STENDRA is a small molecule.

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FAQs

1) Is STENDRA still prescribed versus sildenafil and tadalafil generics?

STENDRA prescriptions persist mainly where coverage supports branded PDE5 inhibitors or where patients remain on the agent due to prior tolerability or perceived onset timing.

2) Will payer step edits reduce STENDRA uptake?

Yes. Step therapy and tiering commonly shift demand to the lowest-cost PDE5 option, which compresses STENDRA volume and pricing.

3) What patents most influence generic avanafil entry in the U.S.?

The patents listed in the FDA Orange Book that cover avanafil composition/formulation and any method-of-use claims are the main determinants of generic design-around viability and launch timing.

4) How quickly do branded PDE5 revenues typically fall after generic avanafil launches?

Revenue compression usually occurs within the first post-launch quarters as payers update formularies and patients switch for cost reasons.

5) Does STENDRA face biosimilar-style competition?

No. STENDRA is not a biologic product, so biosimilar competition is not relevant.

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References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book database).
2. U.S. Food and Drug Administration. Paragraph IV ANDA framework and related guidance materials. (FDA resources).

DrugChatter Q&A for STENDRA

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