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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:NIVAGEN PHARMACEUTICALS, INC.
Route:ORAL
Strength:20 mg in 1 1
Approved: 2023/12/20
NDC:75834-250
Tadalafil
Manufacturer:Aurobindo Pharma Limited
Route:ORAL
Strength:20 mg in 1 1
Approved: 2021/09/06
NDC:65862-853
Tadalafil
Manufacturer:Alembic Pharmaceuticals Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2022/01/10
NDC:62332-179
Tadalafil
Manufacturer:Alembic Pharmaceuticals Limited
Route:ORAL
Strength:2.5 mg in 1 1
Approved: 2023/01/27
NDC:46708-177
Tadalafil
Manufacturer:Amneal Pharmaceuticals NY LLC
Route:ORAL
Strength:5 mg in 1 1
Approved: 2019/01/30
NDC:69238-1347

Singapore Approved Products

ZENAVIL FILM COATED TABLETS 20MG
Manufacturer:MEDOCHEMIE LTD - CENTRAL FACTORY, MEDOCHEMIE LTD - FACTORY AZ (Primary & Secondary Packager)
Form:TABLET, FILM COATED
Strength:20.00mg
Online:Yes
Approved: 2022/03/04
Approval:SIN16440P
A-TADALAFIL FILM-COATED TABLETS 20 MG
Manufacturer:MICRO LABS LIMITED
Form:TABLET, FILM COATED
Strength:20mg
Online:Yes
Approved: 2024/01/26
Approval:SIN16934P
SYNERRV TADALAFIL FILM COATED TABLETS 20MG
Manufacturer:UMEDICA LABORATORIES PVT LTD
Form:TABLET, FILM COATED
Strength:20mg
Online:Yes
Approved: 2023/08/21
Approval:SIN16840P
CIALIS TABLET 2.5 mg
Manufacturer:Lilly del Caribe, Inc.
Form:TABLET, FILM COATED
Strength:2.5 mg
Online:Yes
Approved: 2009/04/23
Approval:SIN13631P
Opsynvi Film-coated Tablets 10mg/20mg
Manufacturer:Penn Pharmaceutical Services Limited
Form:TABLET, FILM COATED
Strength:20mg
Online:Yes
Approved: 2025/05/22
Approval:SIN17241P

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