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. Forty-eight 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:	2
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	95
Patent Applications:	6,324
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 Arizona	Phase 2
University of Florida	Phase 2/Phase 3
Dongkook Pharmaceutical Co., Ltd.	Phase 3

See all CIALIS clinical trials

Pharmacology for CIALIS

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

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

EU/EMA Drug Approvals for CIALIS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Viatris Limited	Talmanco (previously Tadalafil Generics)	tadalafil	EMEA/H/C/004297 Talmanco is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.	Authorised	yes	no	no	2017-01-09
Eli Lilly Nederland B.V.	Tadalafil Lilly	tadalafil	EMEA/H/C/004666 Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required.Tadalafil Lilly is not indicated for use by women.Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.	Authorised	no	no	no	2017-03-22
Eli Lilly Nederland B.V.	Adcirca (previously Tadalafil Lilly)	tadalafil	EMEA/H/C/001021 AdultsTreatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity (see section 5.1).Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.Paediatric populationTreatment of paediatric patients aged 2 years and above with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III.	Authorised	no	no	no	2008-10-01
Eli Lilly Nederland B.V.	Cialis	tadalafil	EMEA/H/C/000436 Treatment of erectile dysfunction.In order for tadalafil to be effective, sexual stimulation is required.Cialis is not indicated for use by women.	Authorised	no	no	no	2002-11-12
Mylan Pharmaceuticals Limited	Tadalafil Mylan	tadalafil	EMEA/H/C/003787 Treatment of erectile dysfunction in adult males.In order for tadalafil to be effective, sexual stimulation is required.Tadalafil Mylan is not indicated for use by women.	Authorised	yes	no	no	2014-11-21

International Patents for CIALIS

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

Country	Patent Number	Title	Estimated Expiration
Tunisia	SN95004	DERIVES TETRACYCLIQUES, PROCEDES DE PREPARATION ET EMPLOI
Luxembourg	90569
Slovakia	15392002	Denná liečba poruchy erekcie použitím inhibítora PDE5 (Daily treatment for erectile dysfunction using a PDE5 inhibitor)
Norway	321602
Australia	6419296

Supplementary Protection Certificates for CIALIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2101777	300813	Netherlands		PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
0740668	03C0017	France		PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
0740668	PA2003001,C0740668	Lithuania		PRODUCT NAME: TADALAFILUM ((6R,12AR)-2,3,6,7,12,12A-HEKSAHIDRO-2-METIL-6-(3,4-METILENDIOKSIFENIL)-PIRAZINO(2',1':6,1)PIRIDO(3,4-B)INDOL-1,4-DIONAS); REGISTRATION NO/DATE: 03/8034/3, 03/8035/3 20030328
0740668	C00740668/01	Switzerland		PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
0740668	91017	Luxembourg