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Last Updated: March 4, 2021

DrugPatentWatch Database Preview

Tadalafil - Generic Drug Details

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What are the generic sources for tadalafil and what is the scope of freedom to operate?

Tadalafil is the generic ingredient in four branded drugs marketed by Eli Lilly Co, Teva Pharms Usa, Lilly, Accord Hlthcare, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Lupin Ltd, Macleods Pharms Ltd, Mylan, Qilu, Sun Pharm, Sunshine, Torrent, Umedica Labs Pvt Ltd, Unichem, Watson Labs Inc, Yangling Buchang, and Zydus Pharms, and is included in thirty-six NDAs. There is one patent protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tadalafil has one hundred and one patent family members in forty-seven countries.

There are twenty-five drug master file entries for tadalafil. Thirty-eight suppliers are listed for this compound.

Drug Prices for tadalafil

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Drug Sales Revenue Trends for tadalafil

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Recent Clinical Trials for tadalafil

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

SponsorPhase
Vanderbilt University Medical CenterPhase 2
Cairo UniversityN/A
Lidia LarrañagaPhase 3

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Pharmacology for tadalafil
Medical Subject Heading (MeSH) Categories for tadalafil
Paragraph IV (Patent) Challenges for TADALAFIL
Tradename Dosage Ingredient NDA Submissiondate
ADCIRCA TABLET;ORAL tadalafil 022332 2009-10-15
CIALIS TABLET;ORAL tadalafil 021368 2008-10-14
CIALIS TABLET;ORAL tadalafil 021368 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
Unichem TADALAFIL tadalafil TABLET;ORAL 209250-003 Mar 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Hetero Labs Ltd Iii TADALAFIL tadalafil TABLET;ORAL 209907-001 Feb 5, 2019 AB2 RX No No   Start Trial   Start Trial   Start Trial
Cipla TADALAFIL tadalafil TABLET;ORAL 209539-001 Mar 26, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Ajanta Pharma Ltd TADALAFIL tadalafil TABLET;ORAL 210392-001 Feb 5, 2019 AB2 RX No No   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

Expired US Patents for tadalafil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003   Start Trial   Start Trial
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tadalafil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2101777 300813 Netherlands   Start Trial PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0740668 SPC/GB03/007 United Kingdom   Start Trial PRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114
2101777 2016C/032 Belgium   Start Trial PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
0740668 C00740668/01 Switzerland   Start Trial PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
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:

Johnson and Johnson
Boehringer Ingelheim
Express Scripts
Baxter
Medtronic
Merck

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