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Cialis generic
About Cialis
Cialis (tadalafil) — originally marketed by Eli Lilly. Class: Phosphodiesterase 5 Inhibitor [EPC].
Approved generic versions (6)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| Tadalafil versus tamsulosin as MET | Beni-Suef University | marketed | ||
| Tadalafil 20 MG | University of Arizona | marketed | ||
| Tadalafil 5mg | Aswan University | marketed | ||
| Tadalafil 5 mg | Eli Lilly and Company | marketed | ||
| Tadalafil Pill | Santa Barbara Cottage Hospital | marketed | ||
| Tadalafil 10 MG | Philip Kern | marketed |
Originator patent timeline
Active patents (4)
- —
11975006· Formulation · US - —
12186322· Formulation · US - —
11382917· Formulation · US - —
11666576· Formulation · US
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.
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Related
- Cialis full drug profile
- Biosimilar tracker (for biologic drugs)
- Patent cliff tracker
- Biosimilar vs generic — what's the difference?
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing