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Last Updated: December 2, 2022

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 five branded drugs marketed by Cmp Dev Llc, Eli Lilly Co, Teva Pharms Inc, Teva Pharms Usa, Lilly, Accord Hlthcare, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Austarpharma, Chartwell Rx, Cipla, Dr Reddys, Hetero Labs Ltd Iii, Lupin Ltd, Macleods Pharms Ltd, Mylan, Prinston Inc, Qilu Pharm Hainan, Rising, Sun Pharm, Sunshine, Torrent, Umedica Labs Pvt Ltd, Unichem, Vkt Pharma, Watson Labs Inc, and Zydus Pharms, and is included in forty-one NDAs. There is one patent 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. Thirty-eight 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
Biozeus Biopharmaceutical S.A.Phase 2
AriBio Co., Ltd.Phase 3
Acerus Pharmaceuticals CorporationPhase 4

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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
Macleods Pharms Ltd TADALAFIL tadalafil TABLET;ORAL 207244-003 Oct 7, 2019 AB1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare TADALAFIL tadalafil TABLET;ORAL 209167-004 Mar 26, 2019 AB1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm TADALAFIL tadalafil TABLET;ORAL 208934-001 Mar 26, 2019 AB1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 See Plans and Pricing See Plans and Pricing
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 See Plans and Pricing See Plans and Pricing
>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
Adcirca is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as World Health Organization 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.
Authorised no no no 2008-10-01
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for tadalafil

Country Patent Number Title Estimated Expiration
China 111683683 PDE V抑制剂的液体口服制剂 (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2019130052 See Plans and Pricing
Canada 3086881 FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tadalafil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0740668 C00740668/01 Switzerland See Plans and Pricing PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
2101777 122016000039 Germany See Plans and Pricing PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
0740668 PA2003001,C0740668 Lithuania See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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