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.
Summary for CIALIS
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 98 |
Clinical Trials: | 94 |
Patent Applications: | 6,090 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for CIALIS |
Drug Sales Revenues: | Drug sales revenues for CIALIS |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for CIALIS |
What excipients (inactive ingredients) are in CIALIS? | CIALIS excipients list |
DailyMed Link: | CIALIS at DailyMed |



Recent Clinical Trials for CIALIS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Florida | Phase 2/Phase 3 |
Dongkook Pharmaceutical Co., Ltd. | Phase 3 |
Washington University School of Medicine | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes 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 | 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 |