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Last Updated: March 19, 2024

ADCIRCA Drug Patent Profile


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Which patents cover Adcirca, and what generic alternatives are available?

Adcirca is a drug marketed by Eli Lilly Co and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Adcirca

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

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Drug patent expirations by year for ADCIRCA
Drug Prices for ADCIRCA

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Recent Clinical Trials for ADCIRCA

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

SponsorPhase
Washington University School of MedicinePhase 1
The Curtis L. Brown Glioblastoma Research FundPhase 1
Vigonvita Life SciencesPhase 2

See all ADCIRCA clinical trials

Pharmacology for ADCIRCA
Paragraph IV (Patent) Challenges for ADCIRCA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ADCIRCA Tablets tadalafil 20 mg 022332 1 2009-10-15

US Patents and Regulatory Information for ADCIRCA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 AB2 RX Yes Yes ⤷  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 ADCIRCA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 ⤷  Try a Trial ⤷  Try a Trial
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 ⤷  Try a Trial ⤷  Try a Trial
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ADCIRCA

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ADCIRCA

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

Country Patent Number Title Estimated Expiration
European Patent Office 0839040 UTILISATION D'INHIBITEURS DE PHOSPHODIESTERASE SPECIFIQUE DE GMPC DANS LE TRAITEMENT DE L'IMPUISSANCE (USE OF CGMP-PHOSPHODIESTERASE INHIBITORS TO TREAT IMPOTENCE) ⤷  Try a Trial
Israel 122870 PHARMACEUTICAL COMPOSITIONS CONTAINING 6-ARYL-2,3,6,7,12,12a-HEXAHYDROPYRAZINO [2'1':'6,1] PYRIDO [3,4-b] INDOLE-1,4-DIONE DERIVATIVES FOR TREATMENT OF MALE ERECTILE DYSFUNCTION ⤷  Try a Trial
Slovakia 1722002 BETA-CARBOLINE DRUG PRODUCTS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ADCIRCA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2101777 300813 Netherlands ⤷  Try a Trial PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0740668 03C0017 France ⤷  Try a Trial PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
0740668 C00740668/01 Switzerland ⤷  Try a Trial PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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