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Last Updated: September 29, 2023

CIALIS Drug Patent Profile


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Which patents cover Cialis, and when can generic versions of Cialis launch?

Cialis is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in CIALIS 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 Cialis

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

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Drug patent expirations by year for CIALIS
Drug Prices for CIALIS

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Drug Sales Revenue Trends for CIALIS

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Recent Clinical Trials for CIALIS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of ArizonaPhase 2
University of FloridaPhase 2/Phase 3
Dongkook Pharmaceutical Co., Ltd.Phase 3

See all CIALIS clinical trials

Pharmacology for CIALIS
Paragraph IV (Patent) Challenges for CIALIS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
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 CIALIS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 AB1 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 AB1 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 AB1 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 AB1 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 CIALIS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 ⤷  Try a Trial ⤷  Try a Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 ⤷  Try a Trial ⤷  Try a Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 ⤷  Try a Trial ⤷  Try a Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 ⤷  Try a Trial ⤷  Try a Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 ⤷  Try a Trial ⤷  Try a Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 ⤷  Try a Trial ⤷  Try a Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for CIALIS

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 CIALIS

See the table below for patents covering CIALIS around the world.

Country Patent Number Title Estimated Expiration
Slovakia 1732002 BETA-CARBOLINE PHARMACEUTICAL COMPOSITIONS ⤷  Try a Trial
Croatia P20020090 FARMACEUTSKI PRIPRAVCI S Ăź-KARBOLINOM (BETA-CARBOLINE PHARMACEUTICAL COMPOSITIONS) ⤷  Try a Trial
Czech Republic 289832 Léčivo pro léčení nebo prevenci samičí sexuální dysfunkce (Medicament for treating or prevention of sexual dysfunction) ⤷  Try a Trial
China 1195349 ⤷  Try a Trial
Slovakia 287869 ⤷  Try a Trial
Poland 324495 ⤷  Try a Trial
Eurasian Patent Organization 004302 β-КАРБОЛИНОВЫЕ ЛЕКАРСТВЕННЫЕ ПРОДУКТЫ (β-CARBOLINE DRUG PRODUCTS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CIALIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2101777 122016000039 Germany ⤷  Try a Trial PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
0740668 SPC/GB03/007 United Kingdom ⤷  Try a Trial PRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114
0740668 300124 Netherlands ⤷  Try a Trial 300124, 20150119, EXPIRES: 20171111
0740668 C00740668/01 Switzerland ⤷  Try a Trial PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
2101777 2016C/032 Belgium ⤷  Try a Trial PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
0740668 CA 2003 00008 Denmark ⤷  Try a Trial
0740668 91017 Luxembourg ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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