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Cymbalta generic

Complete generic competition for Cymbalta (duloxetine): 7 approved generics across manufacturers, 0 filed under FDA review. Sourced from FDA Orange Book + USPTO.

7 approved generics Patents expired

About Cymbalta

Cymbalta (duloxetine) — originally marketed by Eli Lilly and Company. Class: Serotonin and norepinephrine reuptake inhibitor (SNRI). First approved 2004-08-03.

Approved generic versions (7)

GenericManufacturerPhaseFirst approvalCountry
Duloxetine - low dose Boehringer Ingelheim marketed
Duloxetine Hydrochloride Capsules Pfizer marketed
Duloxetine (Cymbalta) New York State Psychiatric Institute marketed
Duloxetine 60mg Ain Shams University marketed
Duloxetine 20 MG Rutgers, The State University of New Jersey marketed
Duloxetine hydrochloride - 60 mg Eli Lilly and Company marketed
Duloxetine or escitalopram New York State Psychiatric Institute 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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