Last reviewed · How we verify

Lexapro generic

Complete generic competition for Lexapro (escitalopram): 15 approved generics across manufacturers, 0 filed under FDA review. Sourced from FDA Orange Book + USPTO.

15 approved generics Patents expired

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)

GenericManufacturerPhaseFirst approvalCountry
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)

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.

Subscribe to generic updates

Related