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Zoloft generic

Complete generic competition for Zoloft (sertraline): 6 approved generics across manufacturers, 0 filed under FDA review. Sourced from FDA Orange Book + USPTO.

6 approved generics Patents expired

About Zoloft

Zoloft (sertraline) — originally marketed by Pfizer Inc.. Class: SSRI (Selective serotonin reuptake inhibitor). First approved 1991-12-30.

Approved generic versions (6)

GenericManufacturerPhaseFirst approvalCountry
SERTRALINE marketed 1991-01-01
Sertraline and Alprazolam XR Indiana University School of Medicine marketed
sertraline fluvoxamine Second Affiliated Hospital, School of Medicine, Zhejiang University marketed
Sertraline HCl Tri-Service General Hospital marketed
Sertraline [Zoloft] Johns Hopkins University marketed
Sertraline + Olanzapine Weill Medical College of Cornell 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.

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Related

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