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:	6,285
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	021368-001	Nov 21, 2003	AB1	RX	Yes	No
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003	AB1	RX	Yes	Yes
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-004	Jan 7, 2008		DISCN	Yes	No

Expired US Patents for CIALIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003	6,943,166*PED
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003	6,943,166*PED
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003	5,859,006*PED

EU/EMA Drug Approvals for CIALIS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
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
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

International Patents for CIALIS

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

Country	Patent Number	Title	Estimated Expiration
Hungary	0200912
Singapore	98384	ARTICLES OF MANUFACTURE
Ukraine	72922	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ С b-КАРБОЛИНОМ (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ СЕКСУАЛЬНОЙ ДИСФУНКЦИИ;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ З b-КАРБОЛІНОМ (ВАРІАНТИ) ТА СПОСІБ ЛІКУВАННЯ СЕКСУАЛЬНОЇ ДИСФУНКЦІЇ (FORMULATION WITH b-CARBOLENE (VARIANTS) AND METHOD FOR TREATING SEXUAL DYSFUNCTION)

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	C00740668/01	Switzerland		PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
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

Cialis (Tadalafil): Market Dynamics and Financial Trajectory

Introduction to Cialis (Tadalafil)

Cialis, known generically as tadalafil, is a phosphodiesterase type 5 (PDE5) inhibitor used primarily for the treatment of erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). Developed and marketed by Lilly ICOS LLC, a joint venture between Eli Lilly and Company and ICOS Corporation, Cialis has become a significant player in the ED treatment market.

Market Size and Growth

The global erectile dysfunction drugs market, in which Cialis is a major component, is expected to experience substantial growth. By 2032, the market is projected to reach approximately USD 6.1 billion, growing at a Compound Annual Growth Rate (CAGR) of 6.8% from 2022[1][3].

Revenue and Sales Milestones

Cialis has achieved notable sales milestones since its introduction. Just over two years after its launch in Europe, Cialis reached $1 billion in global sales, marking a significant milestone for Lilly ICOS[2].

In the first six months after its U.S. launch in 2004, Cialis demonstrated strong market performance, leading in new treatment initiations and switches from other ED treatments. By April 2004, Cialis represented 56% of new treatment initiations by urologists in the U.S., outpacing other ED drugs like Viagra and Levitra[4].

Market Share and Competitive Landscape

Cialis has carved out a substantial market share in the ED treatment sector. In Europe, Cialis claimed market shares ranging from 19% to 39%, and even higher in some markets. In the U.S., it quickly gained ground, representing 19% of new prescriptions for oral ED treatments in April 2004, compared to 14% for Levitra and 67% for Viagra[4].

Distribution Channels

The distribution of Cialis, like other ED drugs, is primarily through hospital pharmacies and retail pharmacies. Retail pharmacies hold the largest revenue share at 46%, while hospital pharmacies account for 35% of the market[1].

Regional Performance

Geographically, North America, particularly the U.S., has been a strong market for Cialis. In 2022, North America held the highest revenue share in the ED drugs market at 51.7%, followed by the Asia Pacific region with a 26.3% share[1].

Factors Driving Growth

Several factors contribute to the growth of the Cialis market:

• Aging Population: The increasing global aging population is a significant driver, as advancing age correlates with a higher prevalence of erectile dysfunction[1][3].
• Lifestyle Factors: Lifestyle-related diseases such as diabetes, obesity, and hypertension also play a crucial role in increasing demand for ED drugs[3].
• Brand Loyalty: Strong brand loyalty, particularly for well-known brands like Cialis, supports market growth[1].

Restraints and Challenges

Despite the growth, the market faces several challenges:

• Low Awareness: In low- and mid-income countries, there is a lack of knowledge about ED and its treatments, which hampers market growth[1].
• Side Effects: Side effects such as nausea, headaches, dizziness, and diarrhea associated with ED drugs can also slow market growth[1].

Financial Performance

Cialis has been financially successful since its launch. In the first quarter of 2004, it achieved $108 million in global sales. By the end of 2004, more than two million men worldwide had been treated with Cialis[4].

Cost and Affordability

The cost of Cialis can vary, but it generally competes with other ED drugs in terms of pricing. For instance, while brand-name Viagra can cost between USD 70 to 75 per pill, generic versions of sildenafil can be significantly cheaper, starting from USD 8.5 or less per pill[1].

Key Takeaways

• Market Growth: The ED drugs market, including Cialis, is expected to grow at a CAGR of 6.8% from 2022 to 2032.
• Revenue: Cialis has reached significant revenue milestones, including $1 billion in global sales shortly after its European launch.
• Market Share: Cialis holds a substantial market share, particularly in new treatment initiations and switches from other ED treatments.
• Regional Performance: North America is the largest market for Cialis, followed by the Asia Pacific region.
• Driving Factors: The aging population, lifestyle factors, and strong brand loyalty drive the growth of the Cialis market.

FAQs

What is the projected market size for the erectile dysfunction drugs market by 2032?

The global erectile dysfunction drugs market is expected to reach approximately USD 6.1 billion by 2032[1].

How has Cialis performed in terms of sales since its launch?

Cialis reached $1 billion in global sales just over two years after its launch in Europe and has continued to show strong market performance, particularly in new treatment initiations and switches from other ED treatments[2][4].

What are the main distribution channels for Cialis?

Cialis is primarily distributed through retail pharmacies, which hold the largest revenue share at 46%, and hospital pharmacies, which account for 35% of the market[1].

What factors are driving the growth of the Cialis market?

The growth of the Cialis market is driven by an increasing aging population, lifestyle-related diseases, and strong brand loyalty[1][3].

Are there any challenges facing the Cialis market?

Yes, the market faces challenges such as low awareness in low- and mid-income countries and side effects associated with ED drugs[1].

Sources

1. Market.us: Erectile Dysfunction Drugs Market Size | CAGR of 6.8% - Global Erectile Dysfunction Drugs Market size is expected to be worth around USD 6.2 Billion by 2032 from USD 3.2 Billion in 2022, growing at a CAGR of 6.8%.
2. Lilly ICOS: Lilly ICOS' Cialis® (tadalafil) Reaches $1 Billion Global Sales Milestone.
3. Maximize Market Research: Erectile Dysfunction Drugs Market: Global Industry Analysis.
4. Lilly ICOS: Lilly ICOS' Cialis (tadalafil) Makes Impressive Strides in First Six Months on the U.S. ED Treatment Market.
5. Verified Market Research: Erectile Dysfunction Drugs Market Size, Share, Trends & Forecast.