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Serving leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Healthtrust
McKinsey
Johnson and Johnson
QuintilesIMS
Argus Health
Daiichi Sankyo
Cerilliant
US Department of Justice

Generated: February 19, 2018

DrugPatentWatch Database Preview

Tadalafil - Generic Drug Details

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What are the generic drug sources for tadalafil and what is the scope of tadalafil patent protection?

Tadalafil
is the generic ingredient in two branded drugs marketed by Eli Lilly Co and Lilly, and is included in two NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tadalafil has three hundred and twenty-four patent family members in sixty-two countries.

There are twenty-three drug master file entries for tadalafil. Ten suppliers are listed for this compound. There are four tentative approvals for this compound.
Pharmacology for tadalafil
Medical Subject Heading (MeSH) Categories for tadalafil
Tentative approvals for TADALAFIL
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up20MGTABLET; ORAL
➤ Sign Up➤ Sign Up20MGTABLET;ORAL
➤ Sign Up➤ Sign Up10MGTABLET;ORAL

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
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for tadalafil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 ➤ Sign Up ➤ Sign Up
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for tadalafil

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,451,807 Methods of treating sexual dysfunction in an individual suffering from a retinal disease, class 1 congestive heart failure, or myocardial infarction using a PDE5 inhibitor ➤ Sign Up
5,981,527 Cyclic GMP-specific phosphodiesterase inhibitors ➤ Sign Up
6,140,329 Use of cGMP-phosphodiesterase inhibitors in methods and compositions to treat impotence ➤ Sign Up
6,841,167 .beta.-carboline pharmaceutical compositions ➤ Sign Up
6,143,746 Tetracyclic cyclic GMP-specific phosphodiesterase inhibitors, process of preparation and use ➤ Sign Up
6,608,065 Use of cGMP phosphodiesterase inhibitors in methods to treat female sexual dysfunction ➤ Sign Up
6,784,179 Tetracyclic derivatives, process of preparation and use ➤ Sign Up
6,369,059 Tetracyclic derivatives, process of preparation and use ➤ Sign Up
6,025,494 Tetracyclic derivatives, process of preparation and use ➤ Sign Up
6,127,542 Tetracyclic derivatives, process of preparation and use ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for tadalafil

Supplementary Protection Certificates for tadalafil

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0740668/01 Switzerland ➤ Sign Up PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
C0017 France ➤ Sign Up PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
2016 00024 Denmark ➤ Sign Up PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
2003001 Lithuania ➤ Sign Up 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
0813 Netherlands ➤ Sign Up PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
C004/2003 Ireland ➤ Sign Up SPC004/2003, 20040610, EXPIRES: 20171111
081 Luxembourg ➤ Sign Up PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
2003 00008 Denmark ➤ Sign Up
0124 Netherlands ➤ Sign Up 300124, 20150119, EXPIRES: 20171111
C/GB03/007 United Kingdom ➤ Sign Up PRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
QuintilesIMS
Merck
UBS
Harvard Business School
Healthtrust
Accenture
AstraZeneca
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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