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, Fourrts Labs, Hangzhou Binjiang, Hetero Labs Ltd Iii, 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-nine 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:	49
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	239
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
Assistance Publique - Hpitaux de Paris	PHASE3
Aspargo Labs, Inc	PHASE2
Assiut University	PHASE3

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
TADLIQ	Oral Suspension	tadalafil	20 mg/5 mL	214522	1	2025-12-03
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
Cipla	TADALAFIL	tadalafil	TABLET;ORAL	209539-004	Mar 26, 2019	AB1	RX	No	No
Ajanta Pharma Ltd	TADALAFIL	tadalafil	TABLET;ORAL	209654-003	Mar 26, 2019	AB1	RX	No	No
Sunshine	TADALAFIL	tadalafil	TABLET;ORAL	211335-003	Mar 26, 2019	AB1	RX	No	No
Hangzhou Binjiang	TADALAFIL	tadalafil	TABLET;ORAL	208824-003	Oct 27, 2020	AB1	RX	No	No
Sun Pharm	TADALAFIL	tadalafil	TABLET;ORAL	208934-003	Mar 26, 2019	AB1	RX	No	No
Teva Pharms Usa	TADALAFIL	tadalafil	TABLET;ORAL	090141-001	May 22, 2018	AB1	RX	No	No
Dr Reddys	TADALAFIL	tadalafil	TABLET;ORAL	210069-002	Mar 26, 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	021368-002	Nov 21, 2003	6,821,975*PED
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003	7,182,958*PED
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-001	Nov 21, 2003	6,943,166*PED
Eli Lilly Co	ADCIRCA	tadalafil	TABLET;ORAL	022332-001	May 22, 2009	5,859,006*PED
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-001	Nov 21, 2003	6,140,329
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-001	Nov 21, 2003	7,182,958*PED
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-003	Nov 21, 2003	6,821,975*PED

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
Morocco	50320	Formulations orales liquides pour inhibiteurs de pde v
Australia	2018397436	Liquid oral formulations for PDE V inhibitors
Singapore	11202006080S	LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS
World Intellectual Property Organization (WIPO)	2019130052
China	111683683	PDE V抑制剂的液体口服制剂 (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)
European Patent Office	3731870	FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)
Australia	2018397436

Supplementary Protection Certificates for TADALAFIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2059246	C202430051	Spain		PRODUCT NAME: UNA COMBINACION DE (A) MACITENTAN O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO Y (B) TADALAFILO O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/24/1859; DATE OF AUTHORISATION: 20240927; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/24/1859; DATE OF FIRST AUTHORISATION IN EEA: 20240927
2059246	C02059246/01	Switzerland		PRODUCT NAME: MACITENTAN UND TADALAFIL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69446 10.10.2024
2101777	CA 2016 00024	Denmark		PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
0740668	PA2003001	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
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
2101777	122016000039	Germany		PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
2101777	2016C/032	Belgium		PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125

TADALAFIL Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Current Market Dynamics for Tadalafil?

Tadalafil, marketed as Cialis by Eli Lilly, is a phosphodiesterase type 5 (PDE5) inhibitor approved for erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension (PAH). Its global market has expanded over the past decade due to increased prevalence of ED and BPH, along with broader acceptance of sexual health medications.

Market Size and Growth Rate

• The global erectile dysfunction drug market was valued at approximately $4.6 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 5.3% from 2023 to 2030, reaching $7 billion by 2030.
• Tadalafil accounts for roughly 55% of global ED market sales, with annual revenues exceeding $2.5 billion in 2022.

Competitive Landscape

• Major competitors include Pfizer's Viagra (sildenafil), Mylan's generic sildenafil, and pharmaceutical companies developing alternative PDE5 inhibitors.
• Tidefall is the only PDE5 inhibitor with approvals for both ED and BPH, giving it a differentiated position in markets where BPH treatment drives sales.

Prescription Trends and Adoption

• Increasing aging populations in North America, Europe, and parts of Asia drive demand.
• Off-label use for athletes and sports enthusiasts is a growing phenomenon, although not approved.
• Growing awareness and destigmatization contribute to rising prescriptions.

How Are Regulatory and Patent Policies Affecting Tadalafil?

Patent Status

• Eli Lilly's patent for Cialis in the US expires in November 2023, opening markets for generic versions.
• Multiple generics from companies like Teva, Mylan, and Sun Pharmaceuticals have gained FDA approval and are marketed at significantly lower prices.

Regulatory Approvals

• Tadalafil holds FDA approval for ED, BPH, and PAH.
• Similar approvals exist across Europe, Asia, and Latin America.
• Challenges in certain markets include regulatory delays and pricing restrictions.

Pricing and Reimbursement

• Price competition among generics has reduced costs. In the US, the average retail price of Cialis was approximately $65 per tablet in 2022, while generic versions are priced around $10-$15.
• Reimbursement policies favor generics, influencing prescribing habits.

What Are the Financial Trajectories and Revenue Projections?

Post-Patent Expiry Impact

• Loss of exclusivity is expected to cause a revenue decline for branded Cialis starting late 2023.
• Forecasts for 2024 estimate a 70%-80% drop in US sales of Cialis branded product due to generics.

Revenue Projections for 2023-2025

Year	Brand Cialis Revenue	Generic Cialis Market Share	Estimated Total ED Market Revenue
2023	$2.5 billion	20%	$4.8 billion
2024	$750 million	80%	$5.2 billion
2025	$600 million	90%	$5.4 billion

Manufacturers’ Strategies

• Eli Lilly aims to sustain revenue through new indications and formulations.
• Generic manufacturers focus on aggressive pricing and expanding access.

Potential Growth Drivers

• Development of new formulations such as long-acting or combination pills.
• Entry into emerging markets with growing demand and low drug penetration.
• Expanding indications to include new therapeutic areas.

How Might Market Dynamics Evolve?

Price Competition and Consolidation

• Increased generic competition will suppress prices and margins.
• Potential consolidation among pharmaceutical companies may influence market dynamics.

Emerging Markets and Demographics

• Countries like India, China, and Brazil present growth opportunities due to increasing healthcare access.
• Aging populations will maintain or increase demand for ED and BPH treatments.

Innovation and Next-Generation Therapies

• Research into novel PDE5 inhibitors and non-PDE5 based therapies could disrupt existing market shares.
• Digital health integration, such as remote monitoring, might improve adherence and outcomes.

What Are the Key Risks and Uncertainties?

• Regulatory delays or barriers in emerging markets.
• Pricing pressures and reimbursement restrictions.
• Patent litigation or patent challenges from generic producers.
• Shifts in prescribing patterns due to healthcare policy changes.

Summary of Market and Financial Outlook

Category	Outlook Summary
Market Size	Growing, expected to reach $7 billion globally by 2030
Revenue Trends	Sharp decline predicted post-2023 due to patent expiry
Competition	Intensifying with multiple generics entering markets
Innovation	Potential to stabilize revenue through new formulations
Regulatory Environment	Pivotal, with patent expiration and approval processes shaping growth

Key Takeaways

• Tadalafil dominates the ED market with substantial revenues, but patent expiry in late 2023 will open the market to generics.
• The generics landscape will significantly compress prices and reduce branded sales.
• Market growth depends on demographic trends, regulatory environments, and the ability of manufacturers to innovate beyond current formulations.
• Emerging markets, aging populations, and new indications will support long-term demand.
• Strategic responses by Eli Lilly and competitors will determine the financial trajectory in the coming years.

FAQs

1. How will patent expiry affect Tadalafil's revenue?
The loss of exclusivity in the US in November 2023 is projected to reduce Eli Lilly's Cialis revenues by approximately 70-80% in the US market due to generic competition.

2. What is the current market share of generic Tadalafil?
As of early 2023, generics hold roughly 20% of the US ED market, but this is expected to rise rapidly post-patent expiry.

3. Are there new indications or formulations for Tadalafil?
Eli Lilly is exploring long-acting formulations and potential additional indications, which could help stabilize revenues after patent expiration.

4. How competitive is the global market for ED drugs?
Highly competitive, with Pfizer's Viagra and generics from multiple manufacturers. Market penetration varies across regions, influenced by regulatory and pricing factors.

5. What strategic options do manufacturers have moving forward?
Focus on product innovation, geographic expansion, pricing strategies, and developing combination therapies to maintain market share amid increasing generic competition.

Citations:

1. MarketResearch.com, 2022. Erectile Dysfunction Market Overview.
2. IQVIA, 2022. Global Pharmaceutical Market Reports.
3. FDA Approved Drugs Database, 2023.
4. Eli Lilly Annual Reports, 2022.
5. EvaluatePharma, 2023. Pharmaceutical Forecasts.