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Lexapro generic
About Lexapro
Lexapro (escitalopram) — originally marketed by Generic (originally Lundbeck/Forest). Class: Selective Serotonin Reuptake Inhibitor (SSRI). First approved 2002-08-14.
Approved generic versions (15)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| ESCITALOPRAM | marketed | 2002-01-01 | ||
| Escitalopram Pill | Peking University | marketed | ||
| Escitalopram+Aripiprazole | Ministry of Health & Welfare, Korea | marketed | ||
| Escitalopram + Celecoxib | University of Pennsylvania | marketed | ||
| Escitalopram treatment | National University Hospital, Singapore | marketed | ||
| Escitalopram 10mg | Wake Forest University Health Sciences | marketed | ||
| Escitalopram+Mirtazapine | Ministry of Health & Welfare, Korea | marketed | ||
| Escitalopram, venlafaxine | K. Lieb | marketed | ||
| escitalopram and tramadol | University of Southern Denmark | marketed | ||
| Escitalopram + Bupropion SR | National Institute of Mental Health (NIMH) | marketed | ||
| Escitalopram, venlafaxine, lithium | K. Lieb | marketed | ||
| escitalopram and eszopiclone | University of California, Los Angeles | marketed | ||
| escitalopram oxalate antidepressant | Weill Medical College of Cornell University | marketed | ||
| Escitalopram (Lexapro) | University of Rochester | marketed | ||
| escitalopram and sertraline | Oregon Health and Science University | 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.