CIALIS Drug Patent Profile

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 22^nd, 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

See drug prices for CIALIS

See drug sales revenues for CIALIS

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

See all CIALIS clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CIALIS

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

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
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003	AB1	RX	Yes	Yes
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-001	Nov 21, 2003	AB1	RX	Yes	No
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003	AB1	RX	Yes	No

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
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-004	Jan 7, 2008
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-004	Jan 7, 2008
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-001	Nov 21, 2003
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003

International Patents for CIALIS

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

Country	Patent Number	Title	Estimated Expiration
Canada	2407519
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)
Poland	199137
Norway	20020532
Brazil	9506559
Austria	169018
Croatia	P20010778	UNIT DOSAGE FORM

Supplementary Protection Certificates for CIALIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0740668	300124	Netherlands		300124, 20150119, EXPIRES: 20171111
2101777	93081	Luxembourg		PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
0740668	SPC/GB03/007	United Kingdom		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		PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
2101777	300813	Netherlands		PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0740668	SPC004/2003	Ireland		SPC004/2003, 20040610, EXPIRES: 20171111
2101777	2016C/032	Belgium		PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125