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Last Updated: May 26, 2022

CIALIS Drug Patent 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.

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

DrugPatentWatch® 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

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

SponsorPhase
University of FloridaPhase 2/Phase 3
Dongkook Pharmaceutical Co., Ltd.Phase 3
Washington University School of MedicinePhase 1

See all CIALIS clinical trials

Paragraph IV (Patent) Challenges for CIALIS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CIALIS Tablets tadalafil 2.5 mg 021368 1 2008-10-14
CIALIS Tablets tadalafil 5 mg, 10 mg and 20 mg 021368 1 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 AB1 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 AB1 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 AB1 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 AB1 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021368-001 Nov 21, 2003 See Plans and Pricing See Plans and Pricing
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 See Plans and Pricing See Plans and Pricing
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 See Plans and Pricing See Plans and Pricing
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 See Plans and Pricing See Plans and Pricing
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 See Plans and Pricing See Plans and Pricing
Lilly CIALIS tadalafil TABLET;ORAL 021368-001 Nov 21, 2003 See Plans and Pricing See Plans and Pricing
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for CIALIS

See the table below for patents covering CIALIS around the world.

Country Patent Number Title Estimated Expiration
Canada 2407519 See Plans and Pricing
Canada 2340636 COMBINAISONS D'INHIBITEURS DE PHOSPHODIESTERASE TETRACYCLIQUE CYCLIQUE SPECIFIQUE DE GMP AVEC D'AUTRES AGENTS THERAPEUTIQUES (COMBINATIONS OF TETRACYCLIC CYCLIC GMP-SPECIFIC PHOSPHODIESTERASE INHIBITORS WITH FURTHER THERAPEUTIC AGENTS) See Plans and Pricing
Poland 199137 See Plans and Pricing
Norway 20020532 See Plans and Pricing
Brazil 9506559 See Plans and Pricing
Austria 169018 See Plans and Pricing
Croatia P20010778 UNIT DOSAGE FORM See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CIALIS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0740668 300124 Netherlands See Plans and Pricing 300124, 20150119, EXPIRES: 20171111
2101777 93081 Luxembourg See Plans and Pricing PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
0740668 SPC/GB03/007 United Kingdom See Plans and Pricing PRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114
2101777 CA 2016 00024 Denmark See Plans and Pricing PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
2101777 300813 Netherlands See Plans and Pricing PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0740668 SPC004/2003 Ireland See Plans and Pricing SPC004/2003, 20040610, EXPIRES: 20171111
2101777 2016C/032 Belgium See Plans and Pricing PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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