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Last Updated: March 1, 2021

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ADCIRCA Drug 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-eight suppliers are listed for this compound. Additional details are available on the tadalafil profile page.

US ANDA 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

Shanghai Institute of Materia Medica, Chinese Academy of SciencesPhase 2
Vigonvita Life SciencesPhase 2
Janssen Research & Development, LLCPhase 1

See all ADCIRCA clinical trials

Pharmacology for ADCIRCA
Paragraph IV (Patent) Challenges for ADCIRCA
Tradename Dosage Ingredient NDA Submissiondate
ADCIRCA TABLET;ORAL tadalafil 022332 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   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ADCIRCA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0740668 03C0017 France   Start Trial PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
0740668 PA2003001,C0740668 Lithuania   Start Trial 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 PA2003001 Lithuania   Start Trial 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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Serving leading biopharmaceutical companies globally:

Express Scripts

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