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Serving leading biopharmaceutical companies globally:

Merck
Federal Trade Commission
Express Scripts
Deloitte
Farmers Insurance
Accenture
Johnson and Johnson
Daiichi Sankyo
US Department of Justice
Fuji

Generated: February 20, 2018

DrugPatentWatch Database Preview

CIALIS Drug Profile

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When do Cialis patents expire, and when can generic versions of Cialis launch?

Cialis is a drug marketed by Lilly and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in CIALIS is tadalafil. There are twenty-three drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the tadalafil profile page.
Summary for CIALIS
Drug patent expirations by year for CIALIS
Pharmacology for CIALIS
Medical Subject Heading (MeSH) Categories for CIALIS

US Patents and Regulatory Information for CIALIS

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 021368-004 Jan 7, 2008 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 CIALIS

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

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Paragraph IV (Patent) Challenges for CIALIS
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 2.5 mg ➤ Subscribe 10/14/2008
➤ Subscribe Tablets 5 mg, 10 mg and 20 mg ➤ Subscribe 11/21/2007

Non-Orange Book US Patents for CIALIS

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
5,981,527 Cyclic GMP-specific phosphodiesterase inhibitors ➤ Try a Free Trial
6,140,329 Use of cGMP-phosphodiesterase inhibitors in methods and compositions to treat impotence ➤ Try a Free Trial
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 ➤ Try a Free Trial
6,143,746 Tetracyclic cyclic GMP-specific phosphodiesterase inhibitors, process of preparation and use ➤ Try a Free Trial
6,608,065 Use of cGMP phosphodiesterase inhibitors in methods to treat female sexual dysfunction ➤ Try a Free Trial
6,841,167 .beta.-carboline pharmaceutical compositions ➤ Try a Free Trial
6,784,179 Tetracyclic derivatives, process of preparation and use ➤ Try a Free Trial
6,369,059 Tetracyclic derivatives, process of preparation and use ➤ Try a Free Trial
6,025,494 Tetracyclic derivatives, process of preparation and use ➤ Try a Free Trial
6,127,542 Tetracyclic derivatives, process of preparation and use ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for CIALIS

Supplementary Protection Certificates for CIALIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2003 00008 Denmark ➤ Try a Free Trial
2003001,C0740668 Lithuania ➤ Try a Free 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
2016 00024 Denmark ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
C/GB03/007 United Kingdom ➤ Try a Free Trial PRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114
017 Luxembourg ➤ Try a Free Trial
C0017 France ➤ Try a Free Trial PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
0124 Netherlands ➤ Try a Free Trial 300124, 20150119, EXPIRES: 20171111
081 Luxembourg ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
C004/2003 Ireland ➤ Try a Free Trial SPC004/2003, 20040610, EXPIRES: 20171111
2016000039 Germany ➤ Try a Free Trial PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Merck
Moodys
Chubb
QuintilesIMS
Queensland Health
Mallinckrodt
Healthtrust
Daiichi Sankyo

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