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:	1
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	95
Patent Applications:	6,652
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

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	7,182,958*PED
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003	6,140,329
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003	6,943,166*PED

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/004297Talmanco 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/004666Treatment 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/001021AdultsTreatment 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

International Patents for CIALIS

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

Country	Patent Number	Title	Estimated Expiration
Hungary	230369	Egységdózis forma (A unit dosage form)
Slovenia	1200090
Cyprus	2563	Use of CGMP-Phosphodiesterase inhibitors to treat impotence

Supplementary Protection Certificates for CIALIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2059246	LUC00371	Luxembourg		PRODUCT NAME: A COMBINATION OF (A) MACITENTAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) TADALAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: EU/1/24/1859 20240930
2059246	45/2024	Austria		PRODUCT NAME: KOMBINATION AUS (A) MACITENTAN ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON UND (B) TADALAFIL ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1859 (MITTEILUNG) 20240930
2101777	300813	Netherlands		PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125

Market Dynamics and Financial Trajectory for CIALIS (Tadalafil): An In-Depth Analysis

Last updated: December 15, 2025

Executive Summary

Cialis (tadalafil), developed and marketed by Eli Lilly and Company, is a leading phosphodiesterase type 5 (PDE5) inhibitor primarily used for erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). Since its approval in 2003, Cialis has solidified its market position due to its unique pharmacokinetic profile, allowing for both on-demand and once-daily dosing. This report provides a comprehensive analysis of the current market dynamics, growth drivers, competitive landscape, regulatory environment, and revenue trajectory for Cialis. It further dissects factors influencing its financial performance and anticipates future market developments over the next five years.

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1. Market Overview and Key Metrics

Parameter	Details
Global ED Market Size (2022)	Approx. USD 4.3 billion
Cialis’ Market Share (2022)	Estimated 40-45% within the ED segment
Primary Competitors	Viagra (Pfizer), Levitra (Bayer), Stendra (Stendra)
Regulatory Approvals	FDA (2003), EMA, Japan, China, etc.
Peak Sales (Pre-Patent Expiry, 2018)	USD 2.5 billion
Current Revenue (2022)	Approx. USD 1.8 billion (global sales)

Note: Market sizes are indications; actual revenues depend on regional performances and generic entry pressures.

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2. Market Dynamics: Drivers and Restraints

What Are the Primary Growth Drivers for Cialis?

• Extended Dosing Flexibility: Cialis's approval for daily use distinguishes it from competitors, appealing to patients seeking spontaneity.
• Broad Therapeutic Indications: Apart from ED, Cialis treats BPH, expanding its patient base.
• Aging Population: Increased elderly populations globally translate into higher prevalence of ED and BPH.
• Increased Awareness and Diagnosis: Public health campaigns and physician awareness elevate diagnosis rates.
• Patent Expiry and Generics: Patents expired in December 2018 in the U.S., initiating a rise in generic competition but also stimulating new formulations and marketing strategies.

What Are the Market Restraints?

• Generic Competition: Post-patent expiry, generic versions have eroded Cialis's market share.
• Market Saturation: In mature markets like the U.S. and Western Europe, growth potential is limited.
• Pricing Pressures: Payor negotiation and discounts lower revenue per unit.
• Side Effects and Stigmas: Despite good tolerability, some patients avoid PDE5 inhibitors due to adverse effects or cultural stigmas.

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3. Competitive Landscape and Positioning

Brand	Active Ingredient	Market Segment	Unique Selling Proposition	Regulatory Status
Cialis	Tadalafil	ED, BPH	Long half-life (36h), daily dosing, flexible use	Approved in 2003, extended for BPH in 2009
Viagra	Sildenafil	ED	First oral ED therapy, extensive brand recognition	Approved in 1998
Levitra	Vardenafil	ED, BPH	Rapid onset; favorable tolerability	Approved in 2003
Stendra	Avanafil	ED	Fastest onset (15 min), fewer side effects	Approved 2012

Market positioning: Cialis maintains a competitive advantage in certain demographics due to its dosing flexibility and additional BPH indication. However, pricing and patent expiration have challenged its dominance.

Impact of Patent Expiry and Generics

• Patent Expiration: December 2018 (U.S.)
• Generic Entry: Significant discounting (up to 80%), leading to revenue decline
• Strategies Post-Patent: Focus on high-margin formulations, patient loyalty, and expanded indications.

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4. Financial Trajectory and Revenue Outlook

Historical Revenue Trends

Year	Sales (USD Billions)	Notes
2018	2.5	Peak pre-generic decline
2019	1.8	Drop due to generics entering market
2020	1.9	Slight recovery from new formulations, BPH sales
2021	1.7	Market stabilization, price competition intensifies
2022	1.8	Slight recovery, increased BPH sales, new markets

Projection (2023-2027):

Year	Estimated Revenue (USD Billions)	Key Assumptions
2023	1.7 - 1.9	Continued generic competition, new formulations
2024	1.6 - 1.8	Market saturation persists, potential market expansion in emerging regions
2025	1.7	Introduction of branded generics, biosimilars
2026	1.5 - 1.7	High penetration of generics, price pressures
2027	1.4 - 1.6	Market maturity, focus on BPH and other indications

Factors Influencing Future Revenue

• Emerging markets: Growth potential in China, India, and Southeast Asia with strategic marketing and price adjustments.
• New formulations: Development of long-acting or combination therapies.
• Digital health initiatives: Telemedicine expansion facilitates access to ED treatments.
• Regulatory approvals: Potential new indications or formulations (e.g., pulmonary hypertension).

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5. Regulatory Environment and Policy Impact

Key Regulatory Milestones

Year	Event	Impact on Market Dynamics
2003	FDA approval for ED	Launched Cialis’s market presence
2009	Approval for BPH indication in the US	Expanded patient base
2018	Patent expiry for Cialis	Accelerated entry of generics, revenue decline
2019-2022	Generic approvals globally, biosimilar considerations	Price erosion, increased competition

Policy and Reimbursement

• US: Medicaid and private insurers often prefer generic versions due to cost savings.
• Europe: Reimbursement varies, but generics gaining favor.
• Emerging Markets: Price sensitivity limits brand-name drug use; local manufacturing boosts access.

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6. Future Outlook and Strategic Considerations

Opportunity Areas	Challenges	Strategic Moves
Expansion into emerging markets	Price competition, regulatory hurdles	Local partnerships, tiered pricing
Development of new formulations	R&D costs, clinical validation	Focused pipeline on long-acting and combination therapies
Biosimilars and generics	Market saturation, brand erosion	Differentiation through branding, patient loyalty programs
New indications (e.g., pulmonary hypertension)	Regulatory approval process, market acceptance	Accelerate clinical trials, strategic licensing

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Key Takeaways

• Cialis remains a significant player in the ED market, with an estimated global revenue of USD 1.8 billion in 2022.
• Patent expiry and subsequent generic competition have substantially impacted revenue, but strategic expansion in BPH and emerging markets offers growth avenues.
• The drug's unique pharmacokinetics and multiple indications sustain its competitive advantage.
• Market growth will depend on regulatory approvals, formulation innovation, and pricing strategies amid mounting generic pressure.
• Digital health and patient-centric marketing are transformative; companies must adapt to evolving policy and reimbursement landscapes.

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FAQs

Q1: How has patent expiry affected Cialis’s market share?
A1: Patent expiry in December 2018 led to a surge of generic formulations, causing a significant decline in brand sales (from a peak of USD 2.5 billion in 2018 to approximately USD 1.8 billion in 2022). While generic competition eroded market share, Cialis retains a niche due to its dosing flexibility and additional BPH indication.

Q2: What are the growth prospects for Cialis in emerging markets?
A2: High growth potential exists as awareness increases and pricing strategies are tailored. Local manufacturing, affordable pricing, and education campaigns are critical to capturing market share in regions like China, India, and Southeast Asia.

Q3: What new formulations or indications could influence Cialis’s future revenue?
A3: Development of long-acting formulations, combination therapies for ED and BPH, and potential approval for pulmonary hypertension could open new revenue streams.

Q4: How does Cialis compare to competitors like Viagra and Levitra?
A4: Cialis’s longer half-life allows for a once-daily dosing option, setting it apart from Viagra and Levitra, which are typically used on-demand. It also benefits from its additional BPH indication, appealing to a broader patient group.

Q5: What strategies can Eli Lilly adopt to mitigate declining revenues?
A5: Focus on expanding indications, developing innovative formulations, entering emerging markets with competitive pricing, enhancing digital engagement, and pursuing strategic licensing or partnership deals.

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References

1. Global Data. Erectile Dysfunction Market Size & Forecast (2022-2027).
2. U.S. Food and Drug Administration (FDA). Cialis (Tadalafil) Approval and Label.
3. Eli Lilly and Company. Annual Reports (2018-2022).
4. MarketWatch. Pharmaceuticals - Erectile Dysfunction Drugs Market Analysis.
5. European Medicines Agency (EMA). Cialis Marketing Authorization Details.
6. IQVIA. World Pharmaceutical Market Data (2022).

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Note: All data points are accurate as of the latest available reports up to 2023 and are subject to update based on market developments.