MedPath

Tadalafil

Generic Name
Tadalafil
Brand Names
Adcirca, Alyq, Cialis, Entadfi, Tadliq, Talmanco (previously Tadalafil Generics), Tadalafil Mylan, Tadalafil Lilly, Adcirca (previously Tadalafil Lilly)
Drug Type
Small Molecule
Chemical Formula
C22H19N3O4
CAS Number
171596-29-5
Unique Ingredient Identifier
742SXX0ICT

Overview

Tadalafil is a selective phosphodiesterase-5 inhibitor that is used in the treatment of erectile dysfunction (ED), pulmonary arterial hypertension (PAH), and benign prostatic hypertrophy. It was first approved in 2003 by the FDA for use in ED and later in 2009 for PAH. In contrast to other PDE5 inhibitors like sildenafil, tadalafil has greater selectivity for PDE5 and a longer half-life which has made it a more suitable option for chronic once-daily dosing in the treatment of PAH.

Background

Tadalafil is a selective phosphodiesterase-5 inhibitor that is used in the treatment of erectile dysfunction (ED), pulmonary arterial hypertension (PAH), and benign prostatic hypertrophy. It was first approved in 2003 by the FDA for use in ED and later in 2009 for PAH. In contrast to other PDE5 inhibitors like sildenafil, tadalafil has greater selectivity for PDE5 and a longer half-life which has made it a more suitable option for chronic once-daily dosing in the treatment of PAH.

Indication

Tadalafil is indicated for the treatment of erectile dysfunction (ED) and either alone or in combination with finasteride for the treatment of benign prostatic hypertrophy (BPH). It is also indicated for the treatment of pulmonary arterial hypertension (PAH) both alone and in combination with macitentan or other endothelin-1 antagonists.

Associated Conditions

  • Benign Prostatic Hyperplasia (BPH)
  • Erectile Dysfunction
  • Pulmonary Arterial Hypertension (PAH)

FDA Approved Products

tadalafil
Manufacturer:Unichem Pharmaceuticals (USA), Inc.
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2024/01/31
NDC:29300-286
Tadalafil
Manufacturer:Bryant Ranch Prepack
Route:ORAL
Strength:5 mg in 1 1
Approved: 2020/11/11
NDC:71335-1884
Tadalafil
Manufacturer:Alembic Pharmaceuticals Inc.
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2022/01/10
NDC:62332-177
tadalafil
Manufacturer:Unichem Pharmaceuticals (USA), Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2024/01/31
NDC:29300-288
Tadalafil
Manufacturer:Quallent Pharmaceuticals Health LLC
Route:ORAL
Strength:5 mg in 1 1
Approved: 2023/03/10
NDC:82009-077

Singapore Approved Products

Opsynvi Film-coated Tablets 10mg/40mg
Manufacturer:Penn Pharmaceutical Services Limited
Form:TABLET, FILM COATED
Strength:40mg
Online:Yes
Approved: 2025/05/22
Approval:SIN17242P

Drug Development Updates

Stay informed with timely notifications on clinical trials and research advancements.

© Copyright 2025. All Rights Reserved by MedPath