Last reviewed · How we verify

Cialis generic

Complete generic competition for Cialis (tadalafil): 6 approved generics across manufacturers, 0 filed under FDA review. 4 active patents remain. Sourced from FDA Orange Book + USPTO.

6 approved generics 4 active patents

About Cialis

Cialis (tadalafil) — originally marketed by Eli Lilly. Class: Phosphodiesterase 5 Inhibitor [EPC].

Approved generic versions (6)

GenericManufacturerPhaseFirst approvalCountry
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)

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.

Subscribe to generic updates

Related

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing