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Last Updated: July 10, 2020

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CIALIS Drug Profile


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Which patents cover Cialis, and when can generic versions of Cialis launch?

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

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

The generic ingredient in CIALIS is tadalafil. There are twenty-five drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the tadalafil profile page.

US ANDA Litigation and Generic Entry Outlook for Cialis

A generic version of CIALIS was approved as tadalafil by TEVA PHARMS USA on May 22nd, 2018.

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Drug patent expirations by year for CIALIS
Drug Prices for CIALIS

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Drug Sales Revenue Trends for CIALIS

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Recent Clinical Trials for CIALIS

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SponsorPhase
University of California, San DiegoPhase 2
Imperial College LondonPhase 3
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityEarly Phase 1

See all CIALIS clinical trials

Pharmacology for CIALIS
Paragraph IV (Patent) Challenges for CIALIS
Tradename Dosage Ingredient NDA Submissiondate
CIALIS TABLET;ORAL tadalafil 021368 2008-10-14
CIALIS TABLET;ORAL tadalafil 021368 2007-11-21

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 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 AB1 RX Yes Yes   Start Trial   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 AB RX Yes No   Start Trial   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 AB RX Yes No   Start Trial   Start Trial   Start Trial
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 AB RX Yes 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 CIALIS

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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0740668 300124 Netherlands   Start Trial 300124, 20150119, EXPIRES: 20171111
2101777 2016C/032 Belgium   Start Trial PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
2101777 122016000039 Germany   Start Trial PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
0740668 CA 2003 00008 Denmark   Start Trial
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 03C0017 France   Start Trial PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Mallinckrodt
Harvard Business School
McKinsey
Boehringer Ingelheim

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