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Last Updated: May 28, 2022

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. Thirty-seven 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

See drug prices for ADCIRCA

Recent Clinical Trials for ADCIRCA

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

SponsorPhase
The Curtis L. Brown Glioblastoma Research FundPhase 1
Washington University School of MedicinePhase 1
Shanghai Institute of Materia Medica, Chinese Academy of 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 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 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 See Plans and Pricing See Plans and Pricing
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 See Plans and Pricing See Plans and Pricing
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ADCIRCA

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

Country Patent Number Title Estimated Expiration
Hungary 222494 Pirazino-pirido-indol-származékok, előállításuk és gyógyszerkénti alkalmazásuk, ezeket tartalmazó gyógyszerkészítmények, valamint intermedierek (PYRAZINO-PYRIDO-INDOLE-DERIVATIVES, PROCESS OF PREPARATION AND USE AS MEDICAMENT, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AND INTERMEDIATES) See Plans and Pricing
Norway 20020531 See Plans and Pricing
Iceland 4252 See Plans and Pricing
Hungary 0202781 See Plans and Pricing
Algeria 3179 Compositions pharmaceutiques à base de beta-carboline. See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ADCIRCA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2101777 CA 2016 00024 Denmark See Plans and Pricing PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
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
0740668 03C0017 France See Plans and Pricing PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
0740668 C00740668/01 Switzerland See Plans and Pricing PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
0740668 91017 Luxembourg See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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