TADALAFIL - Generic Drug Details

What are the generic sources for tadalafil and what is the scope of freedom to operate?

Tadalafil is the generic ingredient in six branded drugs marketed by Cmp Dev Llc, B Better, Eli Lilly Co, Teva Pharms Inc, Teva Pharms Usa, Lilly, Accord Hlthcare, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys, Hangzhou Binjiang, Hetero Labs Ltd Iii, Hibrow Hlthcare, Lupin Ltd, Macleods Pharms Ltd, Norvium Bioscience, Novitium Pharma, Pharmobedient, Prinston Inc, Qilu Pharm Hainan, Rising, Shandong, Sun Pharm, Sunshine, Torrent, Umedica, Unichem, Vkt Pharma, Watson Labs Inc, and Zydus Pharms, and is included in forty-six NDAs. There are four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tadalafil has nine patent family members in nine countries.

There are twenty-five drug master file entries for tadalafil. Forty-eight suppliers are listed for this compound.

Summary for TADALAFIL

International Patents:	9
US Patents:	4
Tradenames:	6
Applicants:	34
NDAs:	46
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	235
Patent Applications:	7,521
Drug Prices:	Drug price trends for TADALAFIL
Drug Sales Revenues:	Drug sales revenues for TADALAFIL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TADALAFIL
What excipients (inactive ingredients) are in TADALAFIL?	TADALAFIL excipients list
DailyMed Link:	TADALAFIL at DailyMed

See drug prices for TADALAFIL

See drug sales revenues for TADALAFIL

Recent Clinical Trials for TADALAFIL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Assiut University	PHASE3
Imperial College London	PHASE2
Aspargo Labs, Inc	PHASE1

See all TADALAFIL clinical trials

Pharmacology for TADALAFIL

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

Medical Subject Heading (MeSH) Categories for TADALAFIL

Phosphodiesterase 5 Inhibitors

Urological Agents

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for TADALAFIL

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

Paragraph IV (Patent) Challenges for TADALAFIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADCIRCA	Tablets	tadalafil	20 mg	022332	1	2009-10-15
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 TADALAFIL

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
Qilu Pharm Hainan	TADALAFIL	tadalafil	TABLET;ORAL	210420-003	Mar 26, 2019	AB1	RX	No	No
Qilu Pharm Hainan	TADALAFIL	tadalafil	TABLET;ORAL	210420-004	Mar 26, 2019	AB1	RX	No	No
Lupin Ltd	TADALAFIL	tadalafil	TABLET;ORAL	210567-003	Mar 26, 2019	AB1	RX	No	No
Accord Hlthcare	TADALAFIL	tadalafil	TABLET;ORAL	209167-003	Oct 23, 2019	AB1	RX	No	No

Expired US Patents for TADALAFIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003	5,859,006*PED
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003	6,943,166*PED
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-004	Jan 7, 2008	6,943,166*PED
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003	6,821,975*PED
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-002	Nov 21, 2003	6,140,329

EU/EMA Drug Approvals for TADALAFIL

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
Eli Lilly Nederland B.V.	Cialis	tadalafil	EMEA/H/C/000436Treatment 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/003787Treatment 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 TADALAFIL

Country	Patent Number	Title	Estimated Expiration
Canada	3086881	FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)
China	111683683	PDE V抑制剂的液体口服制剂 (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)
Singapore	11202006080S	LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS
Morocco	50320	Formulations orales liquides pour inhibiteurs de pde v
European Patent Office	3731870	FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)

Supplementary Protection Certificates for TADALAFIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2059246	PA2024537	Lithuania		PRODUCT NAME: (A) MACITENTANO ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS IR (B)TADALAFILIO ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS DERINYS; REGISTRATION NO/DATE: EU/1/24/1859 20240927
2059246	C02059246/01	Switzerland		PRODUCT NAME: MACITENTAN UND TADALAFIL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69446 10.10.2024
2059246	2024C/552	Belgium		PRODUCT NAME: EEN COMBINATIE VAN (A) MACITENTAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN EN (B) TADALAFIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/24/1859 20240930
2059246	301308	Netherlands		PRODUCT NAME: EEN COMBINATIE VAN (A) MACITENTAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN (B) TADALAFIL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/24/1859 20240930
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

Market Dynamics and Financial Trajectory for Tadalafil: A Comprehensive Analysis

Last updated: August 14, 2025

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Introduction

Tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor, primarily marketed under the brand name Cialis, has established itself as a leading treatment for erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). Since its approval by the U.S. Food and Drug Administration (FDA) in 2003, tadalafil's market presence has evolved considerably, influenced by clinical developments, competitive pressures, regulatory shifts, and changing patient demographics. This article provides a detailed exploration of the market dynamics and financial trajectory of tadalafil, offering strategic insights for stakeholders across pharmaceutical manufacturing, investing, and healthcare sectors.

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Pharmacological Profile and Therapeutic Indications

Tadalafil’s unique pharmacokinetics, notably its long half-life of approximately 17.5 hours, enable once-daily dosing, setting it apart from other PDE5 inhibitors. FDA approvals extend beyond ED to include BPH and pulmonary arterial hypertension (PAH), under brand names such as Adcirca. These multiple indications diversify its revenue streams, impacting overall market dynamics.

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Market Size and Growth Trends

Global Market Valuation

As of 2022, the global erectile dysfunction market was valued at approximately USD 4.2 billion, with tadalafil constituting a significant share due to its popularity and broad indications. The market is projected to expand at a compound annual growth rate (CAGR) of approximately 6-8% through 2028, driven by increased awareness and aging populations.[1]

Regional Dynamics

• North America: Dominates the market, accounting for nearly 45% of sales. The high prevalence of ED (~30 million men in the U.S. alone) and robust healthcare infrastructure bolster sales.
• Europe: Comprises approximately 25% of the market, benefiting from early adoption and widespread prescribing.
• Asia-Pacific: Exhibits the highest growth potential (CAGR ~10%), driven by rising urbanization, increasing discretionary income, and decreased stigmatization regarding sexual health.
• Latin America and Middle East: Show moderate growth prospects with expanding healthcare coverage.

Market Penetration Factors

Key to tadalafil’s growth is its patent exclusivity, marketing strategies, and formulation advantages (e.g., once-daily dosing). The advent of generics following patent expiration in the U.S. (anticipated around 2023-2024) is poised to dramatically influence market share dynamics.

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Competitive Landscape

Major Players

• Eli Lilly and Company: Original innovator and owner of Cialis, with substantial market control.
• Generic Manufacturers: Post-patent expiration, a surge of generic tadalafil producers (e.g., Teva, Mylan) has prompted price competition.
• New Entrants and Biosimilars: While biosimilars are less relevant for small-molecule drugs like tadalafil, emerging competitors with novel PDE5 inhibitors could influence future dynamics.

Pricing and Reimbursement

Brand-name tadalafil commands premium pricing, supported by brand loyalty and clinical efficacy. However, the commercialization of generics has caused considerable price erosion—up to 70% reductions observed in markets where generics are introduced.

Regulatory Influence

Stringent regulatory environments, particularly in Europe and the U.S., influence market entry timings for generics but also protect innovation through patent laws. Patent litigations and data exclusivity periods are critical factors shaping market competitiveness.

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Market Drivers and Inhibitors

Drivers

• Aging Population: Increased prevalence of ED and BPH in men over 50 enhances demand.
• Advancements in Formulation: Development of daily dosing regimens fosters patient adherence and improves quality of life.
• Expanding Indications: Use in PAH and potential future indications broaden market scope.
• Rising Awareness and Healthcare Access: Education campaigns and improved healthcare coverage lead to higher diagnosis rates.

Inhibitors

• Patent Expirations: The imminent patent expiry introduces generics, which could decrease revenue per unit.
• Competitive PDE5 Inhibitors: Sildenafil (Viagra) and vardenafil (Levitra) continue fierce competition, often positioned differently but still directly substitutable.
• Regulatory Barriers: Stringent approval processes and safety concerns can delay market penetration or expansion.
• Side Effect Profiles: Adverse events like headache, flushing, or visual disturbances may limit broader use.

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Financial Trajectory and Revenue Projections

Historical Financial Performance

Eli Lilly's Cialis generated peak annual revenues exceeding USD 2.2 billion pre-patent expiry, with a gradual decline post-2018 owing to generic competition and changing prescribing practices.[2] The company’s strategic investments in pipeline drugs and formulations aim to offset this decline.

Impact of Patent Expiry

Patent expiry, anticipated around 2023-2024 in key markets, is projected to precipitate a steep revenue decline for brand-name Cialis, with estimates suggesting a drop of up to 60-70%. The entrance of generics is expected to rapidly capture market share, reducing prices and overall revenues.

Future Revenue Streams

• Brand Cialis: Revenue stabilization through expanded indications (e.g., BPH, PAH) and market penetration strategies.
• Generic Sales: Volume-driven revenue, with profit margins lower but high volumes sustain overall sales.
• Molecular and Delivery Innovations: Development of novel formulations (e.g., longer-acting, topical) could unlock new revenue potential.

Market Analysts’ Outlook

Industry reports forecast that, despite imminent patent erosion, tadalafil could reestablish robust revenue streams via diversification and global market expansion, especially in emerging economies. However, the overall market share of branded Cialis is expected to diminish significantly over the next 5 years.

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Regulatory and Patent Landscape

Patent protections for Cialis cover the compound and specific formulations but are nearing expiration in multiple jurisdictions, paving the way for generic competition. Eli Lilly has engaged in patent litigations and supplementary protections, such as pediatric exclusivity extensions, to prolong market exclusivity.[3]

Regulatory authorities continue to emphasize safety and efficacy, with post-marketing surveillance crucial for maintaining market confidence. Adaptations to regulatory frameworks, especially relating to biosimilars and generics, remain prominent influences on future market dynamics.

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Strategic Implications for Industry Stakeholders

Investors should recognize that the impending generic wave poses significant revenue risks but also signals growth opportunities for entrants offering lower-cost alternatives. Pharmaceutical companies focusing on innovative formulations or novel indications, such as PDE5 inhibitors with improved safety profiles or different delivery mechanisms, may capitalize on unmet needs.

Healthcare systems could respond with formulary adjustments favoring generics to reduce expenditure, influencing prescribing behaviors and market shares. Mergers and acquisitions are likely as established players consolidate to maintain market relevance and share technological capabilities.

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Key Takeaways

• Tadalafil has cemented a dominant position in ED and BPH treatments, with expanding indications boosting its market appeal.
• The imminent patent expiries are anticipated to trigger significant revenue declines for brand-name Cialis, with generics capturing the majority of market share.
• Regional disparities in market penetration highlight opportunities in emerging markets, particularly in Asia-Pacific.
• Innovation in formulations, delivery systems, and expanded therapeutic indications remains critical to sustaining profitability.
• Strategic planning must account for regulatory environments, patent timelines, and competitive responses to optimize financial outcomes.

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FAQs

1. When will tadalafil's patents expire in major markets?
Patent expirations are projected around 2023-2024 in the U.S. and Europe, enabling generic manufacturers to enter the market.

2. How will generic competition affect pricing for tadalafil?
Generic entry typically leads to price reductions of up to 70%, significantly impacting brand revenues but expanding access through lower-cost options.

3. What new indications are being explored for tadalafil?
Research includes expanding use in pulmonary arterial hypertension, BPH, and potentially other cardiovascular conditions, which could influence future market growth.

4. How does regional regulation influence tadalafil’s market?
Regions with rigorous patent protections and reimbursement policies foster brand stability, while countries with faster approval pathways facilitate rapid generic adoption.

5. What strategies can pharmaceutical companies employ post-patent expiry?
Investing in formulation innovation, diversifying indications, expanding into emerging markets, and engaging in strategic partnerships can help sustain revenues.

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References

[1] Market Research Future. "Global Erectile Dysfunction Market Insights." 2022.
[2] Eli Lilly Annual Report. "Pharmaceutical Portfolio Review." 2022.
[3] U.S. Patent and Trademark Office. "Patent Status for Cialis." 2023.