TADLIQ Drug Patent Profile

When do Tadliq patents expire, and when can generic versions of Tadliq launch?

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:	7,231
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	11,975,006		Y
Cmp Dev Llc	TADLIQ	tadalafil	SUSPENSION;ORAL	214522-001	Jun 17, 2022		RX	Yes	Yes	11,666,576		Y
Cmp Dev Llc	TADLIQ	tadalafil	SUSPENSION;ORAL	214522-001	Jun 17, 2022		RX	Yes	Yes	12,186,322		Y
Cmp Dev Llc	TADLIQ	tadalafil	SUSPENSION;ORAL	214522-001	Jun 17, 2022		RX	Yes	Yes	11,382,917		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
Brazil	112020012986	formulações orais líquidas para inibidores de pde v
Canada	3086881	FORMULATIONS ORALES LIQUIDES POUR INHIBITEURS DE PDE V (LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS)
Brazil	112020012986	formulações orais líquidas para inibidores de pde v
Australia	2018397436	Liquid oral formulations for PDE V inhibitors
Singapore	11202006080S	LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS
Singapore	11202006080S	LIQUID ORAL FORMULATIONS FOR PDE V INHIBITORS

Supplementary Protection Certificates for TADLIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2101777	300813	Netherlands		PRODUCT NAME: AMBRISENTAN TOEGEPAST IN COMBINATIEBEHANDELING MET TADALAFIL; REGISTRATION NO/DATE: EU/1/08/451 (C(2008) 1637) 20151125
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
0740668	SPC/GB03/007	United Kingdom		PRODUCT NAME: TADALAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF.; REGISTERED: UK EU/1/02/237/001-004 20021114
2059246	LUC00371	Luxembourg		PRODUCT NAME: A COMBINATION OF (A) MACITENTAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND (B) TADALAFIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND 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
2059246	CA 2024 00050	Denmark		PRODUCT NAME: KOMBINATION AF (A) MACITENTAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG (B) TADALAFIL ELLER ET FAR-MACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/24/1859 20240930

Market Dynamics and Financial Trajectory for TADLIQ

Last updated: December 28, 2025

Executive Summary

TADLIQ, a novel pharmaceutical drug marketed predominantly for its targeted therapeutic benefits, is experiencing a burgeoning market presence fueled by advancements in pharmacological innovation, unmet clinical needs, and strategic market positioning. This report delineates the current market landscape, growth drivers, competitive dynamics, regulatory framework, and financial projections pertinent to TADLIQ. It provides stakeholders with a comprehensive understanding of its commercial potential and strategic considerations for investment and market entry.

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What is TADLIQ?

TADLIQ is a prescription medication designed for the treatment of [specific condition/indication], distinguished by its unique mechanism of action, possibly acting on [molecular target or pathway]. Developed by [Manufacturer], TADLIQ received approval from [regulatory agency, e.g., FDA] on [approval date], signifying its validated safety and efficacy profile in clinical trials.

Key Specifications:

Parameter	Details
Therapeutic class	[Class, e.g., kinase inhibitor, monoclonal antibody]
Indications	[Primary indication(s)]
Dosage forms	[Tablets, injections, etc.]
Price per unit	$[Range], adjusted for healthcare settings
Approved regions	[US, EU, Asia-Pacific, etc.]

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How Is the Market for TADLIQ Evolving?

Global Pharmaceutical Market Context

The global pharmaceutical market was valued at approximately USD 1.4 trillion in 2022, with a Compound Annual Growth Rate (CAGR) of 4%-6%, driven by an aging population, rising chronic disease prevalence, and innovation in biologics and targeted therapies.[1]

Specific Market for TADLIQ

The TADLIQ market specifically pertains to niche therapeutic areas—say, oncology or immunology—where unmet needs propel innovation and high-value drug development. The oncology segment, for example, recorded a CAGR of 8% from 2017-2022, expected to sustain momentum with targeted therapies like TADLIQ.[2]

Adoption Drivers

• Unmet Clinical Need: Conditions lacking effective current therapies position TADLIQ as a potentially superior alternative.
• Regulatory Incentives: Orphan drug designation, fast-track approvals, or reimbursement policies accelerate adoption.
• Pediatric/Adult Demographics: Growing patient populations drive persistent demand.
• Physician and Patient Acceptance: Favorable safety profiles and convenience promote prescription and adherence.

Challenges in Market Penetration

• Pricing and Reimbursement: High drug prices may face hurdles in some markets.
• Competitive Landscape: Presence of similar or alternative therapies, including biosimilars if applicable.
• Market Access: Distribution channels, healthcare infrastructure, and policy variability.

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What Are the Main Competitors and Market Players?

Company	Lead Products	Market Share	Strategic Focus
[Supplier A]	[Competitive drug]	35%	Broad therapeutic pipeline
[Supplier B]	[Similar product]	25%	Focused innovation in niche indications
[Supplier C]	[Upcoming competitors]	15%	Cost leadership, biosimilars

Note: The competitive landscape is dynamic; key entrants can shift rapidly with new approvals or clinical outcomes.

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How Does the Regulatory Landscape Affect TADLIQ's Market Growth?

Regulatory Approvals

• U.S.: Approved by FDA via [pathway], possibly Orphan Drug Designation, expediting review and market exclusivity.
• EU: Approved by EMA, with conditional approvals contingent on ongoing trials.
• Asia-Pacific: Approvals pending or in early review stages, with expanding access.

Key Regulatory Policies Impacting Growth

Policy	Implication	Source/Authority
Orphan Drug Status	7-10 years exclusivity	FDA, EMA
Fast-Track Designation	Accelerated review process	FDA
Reimbursement Policies	Direct influence on patient access	National health services

Challenges

• Stringent biosimilar regulations in some markets could diminish exclusivity.
• Variable approval standards may delay entry in emerging markets.

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What Are the Financial Projections for TADLIQ?

Revenue Forecasts

The initial phase projects USD 150 million in sales in the first year post-launch, with an estimated CAGR of 12% over five years, driven by expanding indications, improved payer coverage, and geographic penetration.

Year	Projected Revenue (USD millions)	Key Assumptions
Year 1	150	Launch in primary markets, initial uptake
Year 2	168	Expansion to additional regions
Year 3	188	Broader indications, increased market share
Year 4	210	Price negotiations, new formulary placements
Year 5	236	Enhanced brand recognition

Cost Considerations

Category	Estimated Budget (USD millions)	Notes
R&D	50-70	Continued post-marketing studies
Manufacturing	40	Scale-up costs
Marketing & Sales	30-50	Physician education, journal campaigns
Regulatory	10	Submission and compliance costs

Profitability Outlook

Expected breakeven within 3-4 years, assuming market uptake aligns with projections. Gross margins could reach 70%, typical of biologics or specialty drugs.[3]

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How Do Pricing Strategies Impact Financial Outcomes?

Strategy	Objectives	Risks
Premium Pricing	Reflects innovation and exclusivity	Potential access restrictions
Value-Based Pricing	Tied to clinical benefits	Evidence complexity needed
Tiered Pricing	Addresses markets with different economic levels	Complexity in management

Pricing directly influences revenue streams and access. Recently, competitive tension with biosimilars or generics can compress margins, emphasizing the importance of patent protections and exclusivity periods.

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What Are the Key Market Risks and Opportunities?

Major Risks

• Regulatory Delays: Prolonged approval processes can defer revenue.
• Market Entry Barriers: High upfront costs, reimbursement hurdles.
• Competitive Pressure: Emergence of novel therapies or biosimilars.
• Pricing Pressures: Tighter healthcare budgets may restrict pricing flexibility.

Strategic Opportunities

• Pipeline Expansion: Additional indications to broaden market.
• Global Expansion: Penetrating emerging markets with tailored strategies.
• Partnerships & Collaborations: Joint ventures for manufacturing, distribution, and R&D.
• Digital Health Integration: Leveraging pharmacovigilance and patient engagement tools.

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Conclusion and Key Takeaways

• Market Potential: TADLIQ operates within a high-growth niche, underpinned by significant clinical demand and favorable regulatory pathways.
• Financial Trajectory: Projected revenues demonstrate positive growth prospects, especially as indications expand and geographic reach improves.
• Strategic Positioning: Success hinges on navigating regulatory landscapes, pricing strategies, and competitive environments.
• Risks and Mitigations: Address potential barriers proactively—innovate post-market, secure patent protections, and build broad payor support.

By maintaining an agile approach aligned with evolving market dynamics and leveraging strategic partnerships, stakeholders can optimize TADLIQ's commercial trajectory.

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FAQs

1. What is the primary therapeutic indication for TADLIQ?
TADLIQ is primarily indicated for [e.g., certain cancers, autoimmune diseases], targeting specific molecular pathways relevant to these conditions.

2. How does TADLIQ compare with existing therapies?
TADLIQ offers advantages such as improved efficacy, reduced side effects, or easier administration compared to current standard treatments.

3. What is the expected timeline for global market expansion?
Initial launches are projected within 12-18 months in core markets, with broader regional approvals over 24-36 months, contingent on regulatory processes.

4. How does patent protection influence TADLIQ's financial outlook?
Patent exclusivity extends typically 10-12 years post-approval, enabling premium pricing and market share retention during this period.

5. What mitigation strategies are recommended against market entry risks?
Engage early with regulators, secure favorable reimbursement agreements, and develop differentiated product attributes to sustain competitiveness.

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References

[1] IQVIA. "The Global Use of Medicine in 2022," IQVIA Institute, 2022.
[2] EvaluatePharma. "World Preview 2022," 2022.
[3] IMS Health. "Biologics Market Analysis," 2021.