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Last Updated: October 5, 2024

TADALAFIL - Generic Drug Details


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What are the generic sources for tadalafil and what is the scope of freedom to operate?

Tadalafil is the generic ingredient in six branded drugs marketed by Cmp Dev Llc, B Better, Eli Lilly Co, Teva Pharms Inc, Teva Pharms Usa, Lilly, Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys, Fourrts Labs, Hangzhou Binjiang, Hetero Labs Ltd Iii, Lupin Ltd, Macleods Pharms Ltd, Norvium Bioscience, Novitium Pharma, Prinston Inc, Qilu Pharm Hainan, Rising, Shandong, Sun Pharm, Sunshine, Torrent, Umedica, Unichem, Vkt Pharma, Watson Labs Inc, and Zydus Pharms, and is included in forty-six NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tadalafil has nine patent family members in nine countries.

There are twenty-five drug master file entries for tadalafil. Forty-nine suppliers are listed for this compound.

Drug Prices for TADALAFIL

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Drug Sales Revenue Trends for TADALAFIL

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Recent Clinical Trials for TADALAFIL

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SponsorPhase
VA Eastern Colorado Health Care SystemPhase 2
VA Boston Healthcare SystemPhase 2
VA Nebraska Western Iowa Health Care SystemPhase 2

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Pharmacology for TADALAFIL
Medical Subject Heading (MeSH) Categories for TADALAFIL
Paragraph IV (Patent) Challenges for TADALAFIL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ADCIRCA Tablets tadalafil 20 mg 022332 1 2009-10-15
CIALIS Tablets tadalafil 2.5 mg 021368 1 2008-10-14
CIALIS Tablets tadalafil 5 mg, 10 mg and 20 mg 021368 1 2007-11-21

US Patents and Regulatory Information for TADALAFIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hangzhou Binjiang TADALAFIL tadalafil TABLET;ORAL 208824-003 Oct 27, 2020 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx TADALAFIL tadalafil TABLET;ORAL 210716-001 Dec 29, 2020 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Unichem TADALAFIL tadalafil TABLET;ORAL 209250-003 Mar 26, 2019 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ajanta Pharma Ltd TADALAFIL tadalafil TABLET;ORAL 209654-001 Mar 26, 2019 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare TADALAFIL tadalafil TABLET;ORAL 209167-004 Mar 26, 2019 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ajanta Pharma Ltd TADALAFIL tadalafil TABLET;ORAL 209654-002 Mar 26, 2019 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms TADALAFIL tadalafil TABLET;ORAL 206693-001 Mar 26, 2019 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TADALAFIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 ⤷  Sign Up ⤷  Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 ⤷  Sign Up ⤷  Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 ⤷  Sign Up ⤷  Sign Up
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 ⤷  Sign Up ⤷  Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 ⤷  Sign Up ⤷  Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 ⤷  Sign Up ⤷  Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for TADALAFIL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Viatris Limited Talmanco (previously Tadalafil Generics) tadalafil EMEA/H/C/004297
Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.
Authorised yes no no 2017-01-09
Eli Lilly Nederland B.V. Tadalafil Lilly tadalafil EMEA/H/C/004666
Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required.Tadalafil Lilly is not indicated for use by women.Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.
Authorised no no no 2017-03-22
Eli Lilly Nederland B.V. Adcirca (previously Tadalafil Lilly) tadalafil EMEA/H/C/001021
AdultsTreatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.Paediatric populationTreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.
Authorised no no no 2008-10-01
Eli Lilly Nederland B.V. Cialis tadalafil EMEA/H/C/000436
Treatment of erectile dysfunction.In order for tadalafil to be effective, sexual stimulation is required.Cialis is not indicated for use by women.
Authorised no no no 2002-11-12
Mylan Pharmaceuticals Limited Tadalafil Mylan tadalafil EMEA/H/C/003787
Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required.Tadalafil Mylan is not indicated for use by women.
Authorised yes no no 2014-11-21
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TADALAFIL

Country Patent Number Title Estimated Expiration
Singapore 11202006080S LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS ⤷  Sign Up
European Patent Office 3731870 FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS) ⤷  Sign Up
Brazil 112020012986 formulações orais líquidas para inibidores de pde v ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2019130052 ⤷  Sign Up
Japan 2021509114 PDE V阻害剤のための液体経口処方物 ⤷  Sign Up
Canada 3086881 FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS) ⤷  Sign Up
China 111683683 PDE V抑制剂的液体口服制剂 (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TADALAFIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2101777 CA 2016 00024 Denmark ⤷  Sign Up PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
0740668 03C0017 France ⤷  Sign Up PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
0740668 SPC/GB03/007 United Kingdom ⤷  Sign Up PRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114
2101777 122016000039 Germany ⤷  Sign Up PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
2101777 300813 Netherlands ⤷  Sign Up PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0740668 PA2003001,C0740668 Lithuania ⤷  Sign Up PRODUCT NAME: TADALAFILUM ((6R,12AR)-2,3,6,7,12,12A-HEKSAHIDRO-2-METIL-6-(3,4-METILENDIOKSIFENIL)-PIRAZINO(2',1':6,1)PIRIDO(3,4-B)INDOL-1,4-DIONAS); REGISTRATION NO/DATE: 03/8034/3, 03/8035/3 20030328
2101777 2016C/032 Belgium ⤷  Sign Up PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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