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CIALIS Drug Profile
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» See Plans and PricingWhich 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.
Summary for CIALIS
| International Patents: | 101 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 6 |
| Bulk Api Vendors: | 83 |
| Clinical Trials: | 33 |
| Patent Applications: | 4,094 |
| 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 |
| DailyMed Link: | CIALIS at DailyMed |
Recent Clinical Trials for CIALIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Diego | Phase 2 |
| Imperial College London | Phase 3 |
| Sidney Kimmel Cancer Center at Thomas Jefferson University | Early Phase 1 |
Pharmacology for CIALIS
| Drug Class | Phosphodiesterase 5 Inhibitor |
| Mechanism of Action | Phosphodiesterase 5 Inhibitors |
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 |
International Patents for CIALIS
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 0740668 | Start Trial |
| Sweden | 0001518 | Start Trial |
| Poland | 360186 | Start Trial |
| Denmark | 1200090 | Start Trial |
| New Zealand | 514882 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0108686 | Start Trial |
| Israel | 147642 | Start Trial |
| >Country | >Patent Number | >Estimated 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 |
