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Last Updated: April 19, 2025

Tadalafil - Generic Drug Details


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What are the generic drug sources for tadalafil and what is the scope of patent protection?

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, 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.

Drug Prices for tadalafil

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Drug Sales Revenue Trends for tadalafil

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Recent Clinical Trials for tadalafil

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

SponsorPhase
VA Boston Healthcare SystemPhase 2
VA Nebraska Western Iowa Health Care SystemPhase 2
Atlanta VA Medical CenterPhase 2

See all tadalafil clinical trials

Pharmacology for tadalafil
Medical Subject Heading (MeSH) Categories for tadalafil
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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 AB2 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Watson Labs Inc TADALAFIL tadalafil TABLET;ORAL 205885-004 Mar 29, 2019 AB1 RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sun Pharm TADALAFIL tadalafil TABLET;ORAL 208934-004 Mar 26, 2019 AB1 RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Lupin Ltd TADALAFIL tadalafil TABLET;ORAL 210567-002 Mar 26, 2019 AB1 RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chartwell Rx TADALAFIL tadalafil TABLET;ORAL 210716-003 Dec 29, 2020 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chartwell Rx TADALAFIL tadalafil TABLET;ORAL 210716-004 Dec 29, 2020 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 6 of 6 entries

Expired US Patents for tadalafil

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 7,182,958*PED ⤷  Try for Free
Eli Lilly Co ADCIRCA tadalafil TABLET;ORAL 022332-001 May 22, 2009 5,859,006*PED ⤷  Try for Free
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 5,859,006*PED ⤷  Try for Free
Lilly CIALIS tadalafil TABLET;ORAL 021368-002 Nov 21, 2003 7,182,958*PED ⤷  Try for Free
Lilly CIALIS tadalafil TABLET;ORAL 021368-004 Jan 7, 2008 6,140,329 ⤷  Try for Free
Lilly CIALIS tadalafil TABLET;ORAL 021368-003 Nov 21, 2003 5,859,006*PED ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 6 of 6 entries

EU/EMA Drug Approvals for tadalafil

CompanyDrugnameInnProduct Number / IndicationStatusGenericBiosimilarOrphanMarketing AuthorisationMarketing Refusal
Eli Lilly Nederland B.V. Cialis tadalafil EMEA/H/C/000436
Treatment 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
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
Mylan Pharmaceuticals Limited Tadalafil Mylan tadalafil EMEA/H/C/003787
Treatment 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
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
>Company>Drugname>Inn>Product Number / Indication>Status>Generic>Biosimilar>Orphan>Marketing Authorisation>Marketing Refusal
Showing 1 to 5 of 5 entries

International Patents for tadalafil

CountryPatent NumberTitleEstimated Expiration
Australia 2018397436 Liquid oral formulations for PDE V inhibitors ⤷  Try for Free
Brazil 112020012986 formulações orais líquidas para inibidores de pde v ⤷  Try for Free
Japan 2021509114 PDE V阻害剤のための液体経口処方物 ⤷  Try for Free
Morocco 50320 Formulations orales liquides pour inhibiteurs de pde v ⤷  Try for Free
Singapore 11202006080S LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2019130052 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 6 of 6 entries

Supplementary Protection Certificates for tadalafil

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
2101777 122016000039 Germany ⤷  Try for Free PRODUCT NAME: AMBRISENTAN IN VERWENDUNG IN DER KOMBINATIONSTHERAPIE MIT TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 20151120
2059246 122024000070 Germany ⤷  Try for Free 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 20240927
2101777 2016C/032 Belgium ⤷  Try for Free PRODUCT NAME: AMBRISENTAN EN COMBINAISON AVEC LE TADALAFIL; AUTHORISATION NUMBER AND DATE: EU/1/08/451 20151125
2101777 93081 Luxembourg ⤷  Try for Free PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
2101777 CA 2016 00024 Denmark ⤷  Try for Free PRODUCT NAME: AMBRISENTAN USED IN COMBINATION TREATMENT WITH TADALAFIL; REG. NO/DATE: EU/1/08/451 (001-004) 20151125
0740668 PA2003001 Lithuania ⤷  Try for Free 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
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 6 of 6 entries

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

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