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Viagra generic

Complete generic competition for Viagra (sildenafil): 5 approved generics across manufacturers, 0 filed under FDA review. Sourced from FDA Orange Book + USPTO.

5 approved generics Patents expired

About Viagra

Viagra (sildenafil) — originally marketed by Pfizer Inc.. Class: PDE5 inhibitor. First approved 1998-03-27.

Approved generic versions (5)

GenericManufacturerPhaseFirst approvalCountry
Sildenafil therapy plus post-NSRRP HBO2T Hartford Hospital marketed
Sildenafil 20 MG National Taiwan University Hospital marketed
Sildenafil 2 Milton S. Hershey Medical Center marketed
Sildenafil & Vardenafil Rambam Health Care Campus marketed
Sildenafil (Viagra) Charles Drew University of Medicine and Science marketed

Originator patent timeline

Active patents (0)

No active patents tracked.

Expired patents (0)

No expired patents tracked.

How small-molecule generic approval works

Generic versions of small-molecule drugs are approved by the FDA via the Abbreviated New Drug Application (ANDA) pathway under the Hatch-Waxman Act of 1984. Sponsors must demonstrate bioequivalence (pharmacokinetic equivalence within tight bounds) and identical chemical composition — no clinical trials in patients are required. Approval typically takes 18-24 months.

This is different from biosimilars for biologic drugs, which use the more complex 351(k) BLA pathway and typically achieve smaller (15-35%) discounts vs the originator. Small-molecule generics typically launch at 60-80% discount, dropping to 85-95% within 2 years.

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