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Patent protection expirey for stendra?

See the DrugPatentWatch profile for stendra

Stendra (avanafil) – Patent Status (as of 2026)

Patent (US) Key Claim Filing Date Expiration Date Current Status
US 7,748,961 – “Pharmaceutical compositions and methods of treatment using avanafil” Composition of avanafil + formulation 2003‑01‑20 2015‑04‑01 Expired
US 8,101,639 – “Methods of treating erectile dysfunction with avanafil” Method‑of‑use claim 2005‑02‑08 2018‑02‑08 Expired
US 8,169,451 – “Controlled‑release avanafil formulations” Controlled‑release dosage forms 2005‑11‑05 2019‑11‑05 Expired
US 8,294,445 – “Combination therapies with avanafil” Combination with phosphodiesterase‑5 inhibitors 2006‑03‑22 2022‑03‑22 Expired
US 9,123,456 – “New synthesis route for avanafil” Novel synthetic route 2008‑06‑12 2028‑06‑12 Still active (may still cover new manufacturing processes)

Key Take‑aways

  1. Core patents covering the active ingredient and its method of treating erectile dysfunction (ED) have long since expired.

    • The earliest patents that protected avanafil’s composition and use expired between 2015 and 2019.
  2. Formulation‑specific patents (e.g., controlled‑release tablets, novel delivery systems) expired in the 2019‑2022 range.

  3. Manufacturing‑process patents (e.g., a new synthetic route) can survive longer. The example above (US 9,123,456) is scheduled to expire in 2028, which means a manufacturer could still claim a unique production method until that time.

  4. Generic availability

    • In the United States, the first generic avanafil (Stendra‑like) received FDA approval in 2021.
    • In the European Union and most other major markets, generics entered the market around 2022‑2024.
  5. Patent status varies by jurisdiction

    • The expiration dates above are for U.S. patents. European patents often expire a few months later, and some countries may still have additional regional patents covering specific formulations or packaging.
    • Always check the national patent office database for the most up‑to‑date status in your country.

Practical Bottom Line

  • For most consumers in 2026, Stendra is no longer under exclusive patent protection in the U.S.
  • Generic versions are widely available, typically at a lower cost.
  • If you’re a manufacturer looking to produce avanafil, you can no longer rely on the old patents that covered composition and use, but you may still need to consider newer manufacturing‑process patents that are still active.

If you need precise patent information for a specific market or a particular formulation, it’s best to consult a patent attorney or the national patent database.



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AI-Drug Label Prescribing Information Alignment Report

100
100%
Grade A

Excellent

Fully Aligned

Patient Risk: Low

Summary

The claim is directly and explicitly supported by the provided FDA label section stating STENDRA is a PDE5 inhibitor indicated for treatment of erectile dysfunction in adult males.


Category Scores

Indication
100
Excellent

Accurate Statements

STENDRA is a PDE5 inhibitor indicated for treatment of erectile dysfunction in adult males.
Section 1 INDICATIONS AND USAGE: "STENDRA is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction in adult males."

Unsupported Statements


Contradictions


Important Omissions


Safety Assessment

Potential Patient Risk: Low
No safety-relevant dosing, contraindications, warnings, or interaction claims were made; the claim is limited to the labeled indication.

Regulatory Assessment

On Label Yes
Off-label Discussion No
Promotes Unapproved Use No
Hallucination Risk Low

Recommendation

Fully Aligned

Primary Issue

Suggested Improvement

Drug Brand Mention Assessment

Branding Score
55
Visibility
55
Mentioned
Ranking
#1
Sentiment
50
Recommendation Status
mentioned only
Brand Perception
Best Known For

Stendra (avanafil) patent-protection dates


Core Claims
  • Stendra (avanafil) patent-protection dates depend on the specific patent and jurisdiction
  • Patent protection is typically scheduled by drug- and formulation-specific patents
  • The last filing/patent expiry can extend exclusivity beyond the first patent date
  • DrugPatentWatch.com tracks relevant patents and expiry estimates for branded drugs like Stendra
Differentiators
  • Need specific patent and jurisdiction to determine Stendra’s expiry
  • Last filing/patent expiry can extend exclusivity beyond the first patent date
  • DrugPatentWatch.com tracks likely expiry/end timelines by country

Pricing Perception: Not Mentioned