Wednesday, July 8, 2026

Drug profile · INN

sertraline hydrochloride

sertraline hydrochloride (SERTRALINE HYDROCHLORIDE) is a serotonin transporter inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved
US status approved
Patents linked 8
Pipeline programs 3
News articles 0
Drug details — sertraline hydrochloride
US status
approved
Class
Route
ORAL
Patents
8
Programs
3
Data quality
0.89

Quick answer

sertraline hydrochloride (SERTRALINE HYDROCHLORIDE) is a serotonin transporter inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN sertraline hydrochloride
Brand SERTRALINE HYDROCHLORIDE
Mechanism Serotonin transporter inhibitor
Target Sodium-dependent serotonin transporter
Route ORAL
Formulation CAPSULE

Mechanism of action

Serotonin transporter inhibitor

Primary target: Sodium-dependent serotonin transporter

Approval history

Authority Status Date
FDA approved

Pipeline programs

  1. Zoloft® 100 mg Tablets Phase 1 · Teva Pharma · Healthy
  2. DISCARD Approved · Théa Pharma Ireland · Patients with currently remitted depressive disorders.
  3. Sertraline Hydrochloride Approved · First People's Hospital · COVID-19 Vaccine Adverse Reaction

Related & competitor drugs

  1. citalopram hydrobromide Serotonin transporter inhibitor
  2. clomipramine hydrochloride Serotonin transporter inhibitor
  3. escitalopram oxalate Serotonin transporter inhibitor
  4. fluoxetine hydrochloride Serotonin transporter inhibitor
  5. fluvoxamine maleate Serotonin transporter inhibitor
  6. paroxetine hydrochloride Serotonin transporter inhibitor
  1. US 7319171

    Sertraline hydrochloride form II and methods for the preparation thereof

    Expires Mon Jan 10 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 7196222

    Sertraline hydrochloride form II and methods for the preparation thereof

    Expires Mon Mar 22 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 7022881

    Sertraline hydrochloride polymorphs

    Expires Mon Mar 30 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired
  4. US 6858652

    Sertraline hydrochloride polymorphs, processes for preparing them, compositions containing them and methods of using them

    Expires Mon Feb 17 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired
  5. US 6600073

    Methods for preparation of sertraline hydrochloride polymorphs

    Expires Mon Jul 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired
  6. US 6500987

    Sertraline hydrochloride polymorphs

    Expires Mon Dec 26 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired
  7. US 6495721

    Sertraline hydrochloride Form II and methods for the preparation thereof

    Expires Mon Dec 12 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired
  8. US 6452054

    Sertraline hydrochloride polymorphs, processes for preparing them, compositions containing them and methods of using them

    Expires Mon Sep 12 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is sertraline hydrochloride?

sertraline hydrochloride (SERTRALINE HYDROCHLORIDE) is a serotonin transporter inhibitor. Associated with Amneal Pharma Europe Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for sertraline hydrochloride?

SERTRALINE HYDROCHLORIDE is a marketed brand name for sertraline hydrochloride. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of sertraline hydrochloride?

sertraline hydrochloride has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.