TADLIQ Drug Patent Profile

Which patents cover Tadliq, and what generic alternatives are available?

Tadliq is a drug marketed by Cmp Dev Llc and is included in one NDA. There are four patents protecting this drug.

This drug has nine patent family members in nine countries.

The generic ingredient in TADLIQ 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 Tadliq

A generic version of TADLIQ was approved as tadalafil by TEVA PHARMS USA on May 22^nd, 2018.

Summary for TADLIQ

International Patents:	9
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	6,652
Drug Prices:	Drug price information for TADLIQ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TADLIQ
What excipients (inactive ingredients) are in TADLIQ?	TADLIQ excipients list
DailyMed Link:	TADLIQ at DailyMed

See drug prices for TADLIQ

Pharmacology for TADLIQ

Drug Class	Phosphodiesterase 5 Inhibitor
Mechanism of Action	Phosphodiesterase 5 Inhibitors

US Patents and Regulatory Information for TADLIQ

TADLIQ is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cmp Dev Llc	TADLIQ	tadalafil	SUSPENSION;ORAL	214522-001	Jun 17, 2022		RX	Yes	Yes			Y
Cmp Dev Llc	TADLIQ	tadalafil	SUSPENSION;ORAL	214522-001	Jun 17, 2022		RX	Yes	Yes			Y
Cmp Dev Llc	TADLIQ	tadalafil	SUSPENSION;ORAL	214522-001	Jun 17, 2022		RX	Yes	Yes			Y
Cmp Dev Llc	TADLIQ	tadalafil	SUSPENSION;ORAL	214522-001	Jun 17, 2022		RX	Yes	Yes			Y

EU/EMA Drug Approvals for TADLIQ

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 TADLIQ

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

Country	Patent Number	Title	Estimated Expiration
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)
Japan	2021509114	ＰＤＥ Ｖ阻害剤のための液体経口処方物
Brazil	112020012986	formulações orais líquidas para inibidores de pde v
World Intellectual Property Organization (WIPO)	2019130052

Supplementary Protection Certificates for TADLIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2101777	93081	Luxembourg		PRODUCT NAME: AMBRISENTAN UTILISE EN TRAITEMENT COMBINE AVEC TADALAFIL; FRIST REGISTRATION: 20151125
0740668	03C0017	France		PRODUCT NAME: TADALAFIL; REGISTRATION NO/DATE: EU/1/02/237/001-004 20021112
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	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
2059246	122024000070	Germany		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

Market Dynamics and Financial Trajectory for TADLIQ (Tadalafil Liposomal Formulation)

Last updated: July 29, 2025

Introduction

TADLIQ, a proprietary liposomal formulation of tadalafil, signifies an innovative development in the pharmaceutical landscape, targeting erectile dysfunction (ED), pulmonary arterial hypertension (PAH), and potentially other off-label applications. As a novel drug delivery platform, TADLIQ aims to enhance bioavailability, reduce side effects, and optimize patient compliance. This analysis explores the evolving market dynamics influencing TADLIQ’s commercial outlook and projects its financial trajectory within the broader pharmaceutical ecosystem.

Market Landscape and Competitive Environment

Global Erectile Dysfunction Market

The ED therapeutics segment commands significant market size, projected to reach USD 4.4 billion by 2027, growing at a CAGR of approximately 6.4% (Fortune Business Insights [1]). The dominant drug class comprises phosphodiesterase type 5 (PDE5) inhibitors, including brand names like Viagra (sildenafil), Cialis (tadalafil), and Levitra (vardenafil). Tadalafil, the active ingredient in TADLIQ, benefits from its longer half-life and once-daily dosing convenience, positioning it for sustained patient preference.

Pulmonary Arterial Hypertension (PAH) Segment

Tadalafil’s PAH indication, approved globally, continues expanding, driven by increasing awareness, improved diagnostic rates, and off-label uses. The global PAH market is expected to reach USD 7.7 billion by 2028, growing at an estimated CAGR of 7.3% (Market Research Future [2]). Improved formulations with superior pharmacokinetics could result in higher market penetration.

Liposomes and Advanced Drug Delivery Systems

Liposomal formulations are gaining traction due to their ability to improve drug stability, enhance bioavailability, and enable targeted delivery. The global nanomedicine market, including liposomal products, valued at USD 2.6 billion in 2020, is projected to grow markedly (Grand View Research [3]). Pharmaceutical companies are investing heavily in liposomal technology, encouraging the development and commercialization of drugs like TADLIQ.

Competitive Advantages of TADLIQ

TADLIQ’s liposomal encapsulation modifies tadalafil’s pharmacokinetics, potentially allowing:

• Extended duration of action and improved therapeutic window.
• Reduced dosing frequency, improving patient adherence.
• Minimized systemic side effects, further differentiating it from conventional tadalafil tablets.

This positions TADLIQ favorably amidst existing PDE5 inhibitors and PAH treatments — especially for patients with absorption issues or those requiring tailored therapeutic profiles.

Regulatory and Developmental Landscape

Regulatory Pathways

Given TADLIQ’s novelty, it likely undergoes accelerated approval pathways, especially if demonstrating substantial improvements over existing treatments. The FDA’s Fast Track and Breakthrough Therapy designations could expedite its path to market. Regulatory agencies will scrutinize the liposomal formulation’s safety profile, pharmacokinetics, and clinical efficacy.

Clinical Developmental Milestones

Key Phases:

• Phase I: Focus on safety, dosage, and pharmacokinetic profiling. Liposomal encapsulation may present unique variables requiring rigorous assessment.
• Phase II/III: Demonstrating superior efficacy, reduced side effects, and patient adherence benefits. These trials are critical for establishing competitive positioning and securing marketing approval.

Intellectual Property and Patent Strategy

Patents protecting TADLIQ’s formulation specifics, delivery mechanisms, and manufacturing processes are vital. A strong patent portfolio will secure competitive exclusivity, impacting the financial outlook positively.

Market Entry Strategies and Commercial Potential

Partnerships and Licensing

Strategic alliances with major pharmaceutical firms specializing in ED or PAH can accelerate TADLIQ’s commercial rollout. Licensing deals may provide upfront payments, milestone incentives, and royalties, impacting revenue streams.

Pricing and Reimbursement

The proprietary liposomal technology may justify premium pricing, contingent on demonstrated clinical benefit. Reimbursement policies by healthcare payers depend on comparative effectiveness data. Cost-benefit analyses favoring TADLIQ’s longer dosing intervals could favor coverage and adoption.

Market Penetration and Adoption

Physician education on the benefits of liposomal tadalafil will be critical. The fast-growing ED and PAH markets favor early adoption, especially if TADLIQ demonstrates clear efficacy and safety improvements. Launch strategies incorporating key opinion leaders and targeted marketing will determine initial market share.

Financial Projections and Revenue Outlook

Revenue Forecasting

Assuming successful regulatory approval within 2-3 years, initial revenues are projected as follows:

• Year 1-2: Minimal revenue, primarily from licensing agreements or initial sales in select markets.

• Year 3-5: Accelerated adoption driven by clinical data, with projected revenues reaching USD 250-500 million annually, considering:

  • Market penetration rate of 10–15% within the ED segment.
  • Growing acceptance in PAH indications.

• Long-term (Year 6+): Revenues could exceed USD 1 billion, particularly if expanded into new indications or regional markets.

Cost and Investment Considerations

Development costs include clinical trials, regulatory filings, manufacturing scale-up, and marketing. R&D expenditures for liposomal formulation optimization, stability testing, and pharmacokinetic studies may total USD 100-200 million through clinical stages.

Manufacturing investments focused on scalable liposomal technology production will influence margins. Additionally, potential patent litigations or challenges could impact cost structures.

Strategic Risks and Mitigation

Risks include regulatory delays, clinical failure, market rejection, or superior competition. Mitigating strategies involve robust clinical trials demonstrating clear advantages, securing strong patent protections, and early market access strategies.

Emerging Trends Impacting TADLIQ's Financial Trajectory

• Personalized Medicine: Tailoring liposomal tadalafil dosing could broaden indications, concomitant with biomarkers.
• Digital Health Integration: Compliance and adherence tools could facilitate market penetration.
• Global Access: Expanding into emerging markets with tailored pricing may enhance revenue streams.

Conclusion

TADLIQ’s unique liposomal tadalafil positions it to disrupt existing ED and PAH markets, driven by technological superiority and potential clinical benefits. Its financial trajectory hinges on successful development, regulatory validation, strategic partnerships, and market acceptance. The compound’s innovative delivery platform offers a compelling value proposition, with substantial upside for stakeholders prepared to navigate the regulatory, clinical, and commercial complexities.

Key Takeaways

• TADLIQ’s liposomal formulation enhances tadalafil’s pharmacokinetics, offering potential clinical advantages over traditional formulations.
• Growing markets for ED and PAH therapeutics—driven by demographic shifts and increased awareness—present significant commercial opportunities.
• Strategic partnerships, patent protections, and effective commercialization will determine its financial success.
• Early clinical validation and regulatory approval are critical, with revenues possibly exceeding USD 1 billion within five years post-launch.
• Continued innovation in drug delivery and tailored therapy approaches will shape the long-term potential of TADLIQ.

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FAQs

1. What differentiates TADLIQ from traditional tadalafil products?
TADLIQ’s liposomal encapsulation improves bioavailability, prolongs duration of action, reduces dosing frequency, and minimizes systemic side effects, providing enhanced patient adherence and therapeutic efficacy.

2. What markets will primarily drive TADLIQ’s revenue growth?
The primary markets include erectile dysfunction (ED) therapeutics and pulmonary arterial hypertension (PAH). Both segments are expanding globally, especially with innovations offering better efficacy and tolerability.

3. What regulatory challenges could TADLIQ face?
The novel liposomal formulation may require extensive safety and efficacy data. Regulatory agencies may demand comprehensive pharmacokinetic, toxicity, and clinical trial data to approve the product.

4. How could strategic collaborations influence TADLIQ’s market success?
Partnerships with established pharmaceutical firms can expedite development, enhance manufacturing capabilities, and accelerate market entry, ultimately boosting revenue potential.

5. What are the key risks associated with TADLIQ’s commercialization?
Regulatory delays, clinical trial failures, competitive products, and reimbursement hurdles pose risks. Strategic planning and robust clinical data are essential to mitigate these challenges.

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References:

[1] Fortune Business Insights, "Erectile Dysfunction Market Size, Share & Industry Analysis," 2022.
[2] Market Research Future, "Pulmonary Arterial Hypertension (PAH) Market Forecast," 2021.
[3] Grand View Research, "Nanomedicine Market Size, Share & Trends," 2020.