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
Drug Prices:	Drug price information 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

EU/EMA Drug Approvals for TADLIQ

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
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
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

International Patents for TADLIQ

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

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

Supplementary Protection Certificates for TADLIQ

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

Market Dynamics and Financial Trajectory for TADLIQ

Introduction to TADLIQ

TADLIQ, the brand name for tadalafil oral suspension, is a groundbreaking medication approved by the FDA on June 17, 2022, for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability. It is the first and only FDA-approved oral suspension of tadalafil, specifically designed for patients who have difficulty swallowing tablets[1][4].

Market Need and Target Population

PAH is a progressive disorder characterized by abnormally high blood pressure in the pulmonary artery, affecting the blood vessel that carries blood from the heart to the lungs. This condition is part of a broader category known as pulmonary hypertension (PH). The market need for TADLIQ is significant, particularly for patients who struggle with swallowing tablets, a common issue in various patient populations[1].

Unique Selling Points of TADLIQ

Consistent Dosing and Ease of Use

TADLIQ addresses the inconsistencies associated with unapproved crushed or compounded tablets and eliminates the need for complex preparation of powder formulations. This ensures consistent dosing, which is crucial for the effective management of PAH[4].

Patient Convenience

The medication comes in a mild peppermint flavor and is available in 150 mL bottles with a 24-month shelf life, making it a convenient option for patients who require long-term treatment[4].

Financial Feasibility of Developing TADLIQ

Development Costs

The development of innovative medicines like TADLIQ involves significant costs. A financial feasibility study highlighted that the costs for new drug development, particularly for sustained-release dosage forms, are higher and involve longer development durations compared to new generic drugs. For TADLIQ, the costs are substantial, with clinical trials constituting approximately 70% of the total cost[3].

Clinical Trials and Regulatory Requirements

Clinical trials are a critical component of drug development, and for TADLIQ, these trials were essential to establish its efficacy and safety. The study scenarios indicate that the fixed costs for new drug development, including full clinical trials from Phase 1 to Phase 3, range from 18.60 to 20.23 million USD[3].

Payback Period and Revenue Requirements

The financial feasibility analysis suggests that investors need to generate significant revenue to cover the invested capital. For a payback period of 5 years, the income required ranges from 0.20 to 1.80 million USD for a scenario involving only Phase I clinical trials, and 3.01 to 27.11 million USD for a full clinical trial scenario[3].

Market Pricing and Affordability

Current Pricing

TADLIQ is available as a brand name drug only, with no generic version currently available. The cost for a 150 mL supply of TADLIQ oral suspension is approximately $2,085 for cash-paying customers, although prices can vary depending on the pharmacy[5].

Patient Assistance Programs

To make TADLIQ more accessible, various patient assistance programs, copay cards, and manufacturer promotions are available. These programs help reduce the financial burden on patients, making the medication more affordable[5].

Market Growth and Potential

Market Demand

The demand for TADLIQ is driven by the need for effective treatments for PAH, especially among patients with swallowing difficulties. The unique formulation of TADLIQ positions it as a valuable addition to the portfolio of cardiovascular liquids, addressing a previously underserved patient population[4].

Competitive Landscape

As the first and only FDA-approved oral suspension of tadalafil, TADLIQ enjoys a competitive advantage in the market. However, the lack of generic competition currently means that the pricing strategy must balance profitability with patient affordability[1][4].

Policy Recommendations and Incentives

Government Support and Incentives

To alleviate the financial burden associated with clinical studies and drug development, policy recommendations include offering incentives such as grants, tax benefits, or expedited regulatory processes. These incentives can encourage more pharmaceutical companies to invest in innovative medicines like TADLIQ[3].

Collaborative Efforts

Collaboration between industry stakeholders, government bodies, and research institutions is crucial for overcoming the challenges associated with developing innovative medicines. Such collaborations can foster industry expertise and support sustainable development in the pharmaceutical sector[3].

Challenges and Opportunities

High Development Costs

The high costs associated with clinical studies and drug development are significant challenges. However, these costs also present opportunities for innovation and improvement in treatment options for patients with PAH[3].

Regulatory Hurdles

Navigating regulatory requirements is another challenge, but successful navigation can lead to market approval and significant revenue generation. The approval of TADLIQ by the FDA is a testament to the potential for overcoming these hurdles[1].

Key Takeaways

• Unique Formulation: TADLIQ is the first and only FDA-approved oral suspension of tadalafil, designed for patients with difficulty swallowing tablets.
• High Development Costs: The development of TADLIQ involves significant costs, particularly for clinical trials.
• Market Demand: The demand for TADLIQ is driven by the need for effective treatments for PAH, especially among patients with swallowing difficulties.
• Pricing and Affordability: TADLIQ is priced at approximately $2,085 for a 150 mL supply, with patient assistance programs available to reduce costs.
• Policy Recommendations: Incentives such as grants, tax benefits, and expedited regulatory processes can support the development of innovative medicines.

FAQs

Q: What is TADLIQ used for?

A: TADLIQ is used for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability, particularly for patients who have difficulty swallowing tablets.

Q: How much does TADLIQ cost?

A: The cost for a 150 mL supply of TADLIQ oral suspension is approximately $2,085 for cash-paying customers, although prices can vary depending on the pharmacy.

Q: Is TADLIQ available as a generic?

A: No, TADLIQ is currently available only as a brand name drug, with no generic version available.

Q: What are the unique features of TADLIQ?

A: TADLIQ is the first and only FDA-approved oral suspension of tadalafil, ensuring consistent dosing and ease of use for patients with swallowing difficulties.

Q: What are the main challenges in developing TADLIQ?

A: The main challenges include high development costs, particularly for clinical trials, and navigating regulatory requirements.

Sources

1. Brand Institute Partners on Brand Name Development for FDA-Approved Treatment for Pulmonary Arterial Hypertension. Pharm Exec.
2. Financial Feasibility Study and policy recommendations of sustained release dosage forms for IMDs in the Thai pharmaceutical industry. medRxiv.
3. Financial Feasibility Study and policy recommendations of sustained release dosage forms for IMDs in the Thai pharmaceutical industry. medRxiv.
4. CMP Pharma, Inc Announces that Tadliq, the First and Only FDA-Approved Liquid Suspension of Tadalafil, is Now Available. PR Newswire.
5. Tadliq Prices, Coupons, Copay Cards & Patient Assistance. Drugs.com.