Macitentan; tadalafil - Generic Drug Details

What are the generic drug sources for macitentan; tadalafil and what is the scope of freedom to operate?

Macitentan; tadalafil is the generic ingredient in one branded drug marketed by Actelion and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Macitentan; tadalafil has ninety-four patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for macitentan; tadalafil

International Patents:	94
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for macitentan; tadalafil
DailyMed Link:	macitentan; tadalafil at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for macitentan; tadalafil

Constraining patent/regulatory exclusivity:

CHRONIC TREATMENT OF ADULTS WITH PULMONARY ARTERIAL HYPERTENSION (PAH, WHO GROUP I AND WHO FUNCTIONAL CLASS (FC) II-III)

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for macitentan; tadalafil

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

Sponsor	Phase
Janssen Research & Development, LLC	Phase 1
Covance	Phase 3
WorldCare Clinical	Phase 3

See all macitentan; tadalafil clinical trials

Pharmacology for macitentan; tadalafil

Drug Class	Endothelin Receptor Antagonist Phosphodiesterase 5 Inhibitor
Mechanism of Action	Endothelin Receptor Antagonists Phosphodiesterase 5 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for macitentan; tadalafil

C02KX	Antihypertensives for pulmonary arterial hypertension
C02K	OTHER ANTIHYPERTENSIVES
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

C02KX	Antihypertensives for pulmonary arterial hypertension
C02K	OTHER ANTIHYPERTENSIVES
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

G04BE	Drugs used in erectile dysfunction
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for macitentan; tadalafil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No			Y
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-002	Mar 22, 2024		RX	Yes	Yes			Y

International Patents for macitentan; tadalafil

Country	Patent Number	Title	Estimated Expiration
Morocco	30704	COMPOSITIONS THERAPEUTIQUES
Denmark	2059246
Norway	20032699
South Korea	100819668

Supplementary Protection Certificates for macitentan; tadalafil

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	SPC/GB14/018	United Kingdom		PRODUCT NAME: MACITENTAN, WHICH IS N-(5-(4-BROMOPHENYL)-6-(2((5-BROMOPYRIMIDIN-2-YL)OXY)ETHOXY)PYRIMIDIN-4-YL)-N'-PROPYLSULFURIC DIAMIDE; REGISTERED: UK EU/1/13/893 20131220
1345920	14C0017	France		PRODUCT NAME: MACITENTAN ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/893 20131220
1345920	132014902244514	Italy		PRODUCT NAME: MACITENTAN(OPSUMIT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/893/001-002, 20131220
1345920	1490025-2	Sweden		PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220

Macitentan; tadalafil Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Macitentan and Tadalafil

Introduction

Macitentan and tadalafil are two medications that have gained significant attention in the treatment of pulmonary arterial hypertension (PAH). Here, we will delve into the market dynamics and financial trajectory of these drugs, highlighting their current status, future projections, and key factors influencing their market performance.

Market Overview of Macitentan

Current Market Status

Macitentan, marketed under the brand name Opsumit, is an endothelin receptor antagonist used primarily in the treatment of PAH. The global macitentan market has been growing steadily, driven by the increasing prevalence of PAH and the drug's efficacy in improving patient outcomes[1].

Key Players

The macitentan market is dominated by several key players, including Bio Crick, AbMole Bioscience, Aurum Pharmatech LLC, A2Z Chemical, eNovation Chemicals, Active Biopharma, Parkway Scientific, Clearsynth, Synblock Inc, Spring Pharma, Pidrug, and Johnson&Johnson. These companies play a crucial role in the production and distribution of macitentan[1].

Market Segmentation

The macitentan market is segmented by type (99% Purity Type, 98% Purity Type, 97% Purity Type, 95% Purity Type, and others) and by application (Generic Drug, Original Drug). This segmentation helps in understanding the diverse needs of the market and tailoring strategies accordingly[1].

Market Dynamics of Tadalafil

Current Market Status

Tadalafil, known for its use in treating erectile dysfunction, is also used in combination with macitentan for PAH treatment. The market for tadalafil is robust, with a strong presence in both the pharmaceutical and MedTech sectors[2].

Combination Therapy with Macitentan

The A DUE trial has shown that the fixed-dose combination of macitentan and tadalafil is superior to either agent as monotherapy in reducing pulmonary vascular resistance (PVR) among PAH patients. This combination therapy is gaining traction due to its enhanced efficacy and convenience of a single pill[3].

Financial Trajectory

Revenue and Growth

Actelion, the original developer of macitentan (Opsumit), reported strong financial results in 2016, with Opsumit sales growing to CHF 831 million, a 57% increase at constant exchange rates. This growth trend is expected to continue as the global macitentan market is anticipated to expand further by 2030[5].

Cost and Cost-Effectiveness

The fixed-dose combination of macitentan and tadalafil (Opsynvi) offers significant cost savings compared to taking the drugs separately. At an annual cost of $48,202 per patient, the combination therapy can save between $7,388 to $9,140 per patient annually, depending on the list prices of the individual drugs[4].

Financial Performance of Key Players

Companies involved in the production and distribution of these drugs have seen positive financial results. For instance, Johnson&Johnson reported a 6.3% increase in sales to $25.5 billion in the second quarter of 2023, with pharmaceutical sales contributing significantly to this growth[2].

Clinical Efficacy and Safety

A DUE Trial Findings

The A DUE trial demonstrated that the combination of macitentan and tadalafil significantly reduces PVR and improves six-minute walk distance (6MWD) compared to monotherapy. However, the combination therapy also showed higher rates of anemia and hypotension[3].

Bioequivalence and Pharmacokinetics

Studies have shown bioequivalence between the fixed-dose combination and the individual components administered separately. This ensures that the combination therapy maintains the same pharmacokinetic profile as the individual drugs, which is crucial for patient safety and efficacy[4].

Market Trends and Future Outlook

Increasing Prevalence of PAH

The growing prevalence of PAH is a key driver for the macitentan and tadalafil markets. As more patients are diagnosed and treated, the demand for these medications is expected to rise.

Advancements in Combination Therapies

The success of the macitentan and tadalafil combination therapy highlights the potential for future combination treatments. This trend is likely to continue as researchers seek to improve patient outcomes through synergistic drug combinations.

Regulatory and Reimbursement Landscape

Regulatory approvals and reimbursement policies play a critical role in the market dynamics of these drugs. The approval of the macitentan-tadalafil fixed-dose combination in various regions and its inclusion in public drug plans will significantly impact its adoption and financial performance[4].

Challenges and Opportunities

Side Effects and Safety Profile

While the combination therapy offers improved efficacy, it also comes with a higher risk of certain side effects such as anemia and hypotension. Managing these side effects will be crucial for patient adherence and overall treatment success[3].

Cost and Accessibility

Despite the cost savings of the fixed-dose combination, the high annual cost of $48,202 per patient remains a significant barrier to access. Efforts to reduce costs or improve reimbursement could expand the market reach[4].

Research and Development

Continued research into new combination therapies and improved formulations will drive innovation and growth in the market. The potential for these drugs to be used in other indications could also expand their market scope.

Key Takeaways

• Market Growth: The global macitentan market is expected to grow significantly by 2030, driven by the increasing prevalence of PAH and the efficacy of combination therapies.
• Combination Therapy: The fixed-dose combination of macitentan and tadalafil has shown superior efficacy compared to monotherapy in reducing PVR and improving 6MWD.
• Cost-Effectiveness: The combination therapy offers significant cost savings compared to individual drug treatments.
• Clinical Efficacy: The A DUE trial and other studies have demonstrated the clinical benefits of the macitentan-tadalafil combination, despite higher rates of certain side effects.
• Regulatory and Reimbursement: Regulatory approvals and reimbursement policies are critical for the market success of these drugs.

FAQs

What is the primary use of macitentan and tadalafil in combination?

The primary use of macitentan and tadalafil in combination is for the treatment of pulmonary arterial hypertension (PAH), where it has shown superior efficacy in reducing pulmonary vascular resistance (PVR) compared to monotherapy[3].

Which companies are key players in the macitentan market?

Key players in the macitentan market include Bio Crick, AbMole Bioscience, Aurum Pharmatech LLC, A2Z Chemical, eNovation Chemicals, Active Biopharma, Parkway Scientific, Clearsynth, Synblock Inc, Spring Pharma, Pidrug, and Johnson&Johnson[1].

What are the cost savings of the macitentan-tadalafil fixed-dose combination?

The macitentan-tadalafil fixed-dose combination can save between $7,388 to $9,140 per patient annually compared to taking the drugs separately[4].

What are the common side effects of the macitentan-tadalafil combination therapy?

Common side effects of the combination therapy include anemia and hypotension, which are more frequent compared to monotherapy[3].

How does the regulatory landscape impact the market for macitentan and tadalafil?

Regulatory approvals and reimbursement policies significantly impact the market adoption and financial performance of macitentan and tadalafil. Inclusion in public drug plans and favorable reimbursement policies can enhance accessibility and market growth[4].

Sources

1. Global Macitentan Market Research Report 2024 - Valuates Reports
2. 2023 Second-Quarter Financial Results - Johnson&Johnson
3. Macitentan/Tadalafil Fixed-Dose Combination in Pulmonary Arterial Hypertension - A DUE - American College of Cardiology
4. Macitentan and Tadalafil (Opsynvi) - Canada's Drug Agency
5. Actelion Announces Excellent Financial Results for 2016 - GlobeNewswire