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Last Updated: November 21, 2024

TADALAFIL Drug Patent Profile


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When do Tadalafil patents expire, and what generic alternatives are available?

Tadalafil is a drug marketed by Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys, Hangzhou Binjiang, Hetero Labs Ltd Iii, Hibrow Hlthcare, Lupin Ltd, Macleods Pharms Ltd, Norvium Bioscience, Novitium Pharma, Prinston Inc, Qilu Pharm Hainan, Rising, Shandong, Sun Pharm, Sunshine, Teva Pharms Usa, Torrent, Umedica, Unichem, Vkt Pharma, Watson Labs Inc, and Zydus Pharms. and is included in forty NDAs.

The generic ingredient in TADALAFIL is tadalafil. There are twenty-five drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the tadalafil profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tadalafil

A generic version of TADALAFIL was approved as tadalafil by TEVA PHARMS USA on May 22nd, 2018.

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Drug patent expirations by year 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
Qilu Pharm Hainan TADALAFIL tadalafil TABLET;ORAL 210420-003 Mar 26, 2019 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Unichem TADALAFIL tadalafil TABLET;ORAL 209250-002 Mar 26, 2019 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hangzhou Binjiang TADALAFIL tadalafil TABLET;ORAL 208824-004 Oct 27, 2020 AB1 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cipla TADALAFIL tadalafil TABLET;ORAL 210255-001 Feb 5, 2019 AB2 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sunshine TADALAFIL tadalafil TABLET;ORAL 213496-001 Nov 23, 2020 AB2 RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms TADALAFIL tadalafil TABLET;ORAL 206693-003 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

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

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