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Cymbalta generic
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)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| 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)
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.