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, 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 three 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-six suppliers are listed for this compound.

Summary for TADALAFIL

International Patents:	9
US Patents:	3
Tradenames:	6
Applicants:	33
NDAs:	46
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	214
Patent Applications:	6,539
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
VA Eastern Colorado Health Care System	Phase 2
VA Boston Healthcare System	Phase 2
VA Nebraska Western Iowa Health Care System	Phase 2

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
Aurobindo Pharma Ltd	TADALAFIL	tadalafil	TABLET;ORAL	206286-001	Feb 5, 2019	AB2	RX	No	No
Zydus Pharms	TADALAFIL	tadalafil	TABLET;ORAL	206693-001	Mar 26, 2019	AB1	RX	No	No
Macleods Pharms Ltd	TADALAFIL	tadalafil	TABLET;ORAL	207290-001	Oct 16, 2019	AB2	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	021368-004	Jan 7, 2008	7,182,958*PED
Lilly	CIALIS	tadalafil	TABLET;ORAL	021368-001	Nov 21, 2003	6,943,166*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/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

International Patents for TADALAFIL

Country	Patent Number	Title	Estimated Expiration
Australia	2018397436	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)
Morocco	50320	Formulations orales liquides pour inhibiteurs de pde v

Supplementary Protection Certificates for TADALAFIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0740668	C00740668/01	Switzerland		PRODUCT NAME: TADALAFILUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56018 04.05.2004
2101777	93081	Luxembourg		PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125

TADALAFIL Market Analysis and Financial Projection

Tadalafil Market Dynamics and Financial Trajectory

Introduction to Tadalafil

Tadalafil, marketed under the trade name Cialis among others, is a prescription medication used to treat erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension. Its unique profile, including a long duration of action up to 36 hours, makes it a preferred choice for many patients.

Market Size and Growth

The tadalafil market was valued at USD 6.25 billion in 2024 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 11.6% to reach USD 17.00 billion by 2034[1].

Key Drivers of the Market

Increasing Knowledge about Men's Health

Public awareness campaigns and open discussions about men's health have reduced the stigma associated with erectile dysfunction. This increased awareness has led more men to seek treatment, driving the demand for tadalafil[1].

Verified Effectiveness and Durable Results

Tadalafil's proven efficacy and long-lasting effects make it a preferred treatment option. Unlike some other ED drugs that must be taken shortly before sexual activity, tadalafil's extended duration of action offers greater convenience and discretion, enhancing patient compliance[1].

Regional Insights

North America

North America is a mature market for tadalafil, particularly for treating ED. The region's growth is fueled by increased awareness campaigns and educational materials, which have normalized seeking treatment for men's health issues[1].

Asia Pacific

The Asia Pacific region presents significant growth opportunities due to rising disposable incomes, urbanization, and growing awareness of men's health. Countries like China and India are driving this growth with their increasing purchasing power and adoption of ED treatments[1][4].

Europe

In Europe, tadalafil is well-established not only for ED but also for other applications. Regulatory frameworks and healthcare systems play a crucial role in shaping market dynamics in this region[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa are emerging markets with growing demand for tadalafil. However, these regions face challenges such as limited access to healthcare facilities and economic instability, which can restrict market growth[1].

Market Segmentation

The tadalafil market is segmented based on purity, form, application, and region. The key applications include erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension. The market is also segmented by form into tablets and capsules, and by purity into 98% and above 98%[1].

Competitive Landscape

Key players in the tadalafil market include Glenmark Pharmaceuticals Ltd., Teva Pharmaceutical Industries Ltd., Eli Lilly and Co. Pvt. Ltd., Cadila Pharmaceuticals Ltd., Cipla Ltd., Torrent Pharma, Camber Pharmaceuticals, and Dr. Reddy’s Laboratories. These companies are driving market growth through product launches, generic versions, and strategic collaborations[1][4].

Financial Trajectory

Revenue Growth

The tadalafil market is expected to experience significant revenue growth, driven by increasing demand and expanding into new geographic regions. The projected CAGR of 11.6% from 2024 to 2034 indicates a robust financial trajectory[1].

Regional Revenue Contribution

North America is expected to dominate the market in terms of revenue, followed by the Asia Pacific region, which is anticipated to grow at the highest rate during the forecast period. Europe and other regions will also contribute substantially to the overall revenue growth[1][4].

Impact of Generic Versions

The availability of generic versions of tadalafil, such as those launched by Teva Pharmaceutical Industries Ltd., has increased accessibility and affordability, further driving market growth. Generic versions often lead to higher sales volumes due to their lower prices compared to branded products[4].

Technological Advancements and Regulatory Approvals

Technological advancements, such as the development of new dosage forms and regulatory approvals, are also driving the growth of the tadalafil market. For instance, the launch of generic versions of tadalafil tablets has expanded treatment options and increased market penetration[4].

Challenges and Restraints

Despite the growth potential, the tadalafil market faces challenges such as possible adverse reactions, which can act as a market restraining factor. Additionally, economic instability and limited access to healthcare in certain regions can hinder market growth[1].

Market Opportunities

The increasing incidence of erectile dysfunction, particularly in emerging markets, presents a lucrative opportunity for the tadalafil market. Improved healthcare infrastructure, rising awareness about ED, and the availability of prescription and generic medications are key factors driving this opportunity[4].

Key Takeaways

• The tadalafil market is projected to grow significantly, driven by increasing awareness about men's health and the drug's verified effectiveness.
• North America and the Asia Pacific region are key drivers of market growth.
• Generic versions and technological advancements are expanding market reach.
• Regulatory frameworks and healthcare systems play a crucial role in shaping market dynamics.
• Emerging markets offer significant growth opportunities despite challenges.

Frequently Asked Questions (FAQs)

What is the current market size of tadalafil and its projected growth?

The tadalafil market was valued at USD 6.25 billion in 2024 and is expected to grow at a CAGR of 11.6% to reach USD 17.00 billion by 2034[1].

What are the key drivers of the tadalafil market?

Key drivers include increasing knowledge about men's health and the verified effectiveness and durable results of tadalafil[1].

Which regions are expected to dominate the tadalafil market?

North America is expected to dominate the market, followed by significant growth in the Asia Pacific region[1][4].

Who are the key players in the tadalafil market?

Key players include Glenmark Pharmaceuticals Ltd., Teva Pharmaceutical Industries Ltd., Eli Lilly and Co. Pvt. Ltd., and others[1].

What challenges does the tadalafil market face?

The market faces challenges such as possible adverse reactions and limited access to healthcare in certain regions[1].

Cited Sources:

1. Prophecy Market Insights - Tadalafil Market Size Global Report, 2024 – 2034
2. Trinity Delta - Eroxon poised for launch in key US market
3. SkyQuest - Erectile Dysfunction Drugs Market Size, Trends & Forecast | 2031
4. Allied Market Research - Erectile Dysfunction Drugs Market Statistics | Projection - 2032