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Viagra generic
About Viagra
Viagra (sildenafil) — originally marketed by Pfizer Inc.. Class: PDE5 inhibitor. First approved 1998-03-27.
Approved generic versions (5)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| 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)
Expired patents (0)
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.