FDA Orange Book · active-ingredient family
Avanafil
Avanafil: 1 brand, 1 generic; first approved Apr 27, 2012; generic available.
Generic available
Generic status & protection
Generic available: 1 ANDA application approved.
Brands (NDA)
1
Generics (ANDA)
1
Listed patents
0
Presentations
6
Brand (NDA) products
Originator applications
- STENDRARLDVIVUS LLCNDA 20227620123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB
Generic (ANDA) products (1)
Abbreviated applications
- AVANAFILHETERO LABS LTD VANDA 20926620243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 200MG TABLET ORAL Rx AB
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
14 yr 6 mo ago
Most recent approval
2 yr 3 mo ago
Approvals span 2012–2024 across 2 FDA applications.
Brand (NDA) 150%
Generic (ANDA) 150%
Avanafil: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
