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 one hundred patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for macitentan; tadalafil

International Patents:	100
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	10
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
Humanis Saglık Anonim Sirketi	PHASE1
Janssen Research & Development, LLC	Phase 1
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	218490-002	Mar 22, 2024		RX	Yes	Yes					Y
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-002	Mar 22, 2024		RX	Yes	Yes					Y
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-002	Mar 22, 2024		RX	Yes	Yes
Actelion	OPSYNVI	macitentan; tadalafil	TABLET;ORAL	218490-001	Mar 22, 2024		RX	Yes	No

International Patents for macitentan; tadalafil

Country	Patent Number	Title	Estimated Expiration
Finland	C20240045
Austria	323079
Cyprus	1114735
Slovenia	2059246
Russian Federation	2009111378
Chile	2007002494

Supplementary Protection Certificates for macitentan; tadalafil

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345920	122014000056	Germany		PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
2059246	24C1054	France		PRODUCT NAME: COMBINAISON DE (A) MACITENTAN OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET (B) TADALAFIL OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/24/1859 20240930
2059246	45/2024	Austria		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 (MITTEILUNG) 20240930
1345920	C01345920/01	Switzerland		PRODUCT NAME: MACITENTAN; REGISTRATION NO/DATE: SWISSMEDIC 61863 06.02.2014
1345920	300672	Netherlands		PRODUCT NAME: MACITENTAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/13/893/001-003 20131220
1345920	1490025-2	Sweden		PRODUCT NAME: MACITENTAN; REG. NO/DATE: EU/1/13/893 20131220

Market Dynamics and Financial Trajectory for Macitentan and Tadalafil

Last updated: February 13, 2026

What are the current market sizes for macitentan and tadalafil?

The global market for macitentan was valued at approximately $650 million in 2022, driven by its approval in pulmonary arterial hypertension (PAH). Tadalafil’s market surpasses that, with an estimated valuation exceeding $3 billion in 2022 for indications including erectile dysfunction (ED) and benign prostatic hyperplasia (BPH). Tadalafil benefits from broader indications and established generic competition, impacting its growth trajectory.

How are regulatory approvals and indications influencing market expansion?

Macitentan

• Approved by FDA and EMA in 2013 for PAH.
• Approved for PAH; no additional indications.
• Market growth limited by the specificity of PAH treatment and competition with other ERA drugs like ambrisentan and bosentan.

Tadalafil

• Approved for ED (2003), BPH (2011), pulmonary hypertension (2009 by FDA).
• Expanded use cases enhance market size.
• The inclusion of late-stage ed- and BPH formulations and potential for COVID-19 related pulmonary indications enhance growth prospects.

What are the competitive landscapes for these drugs?

Macitentan

• Competition from bosentan (Tracleer), ambrisentan (Letairis).
• Patent expiration date for brand is expected around 2028-2030, with generics entering thereafter.
• Limited patent challenges but pressure from biosimilars if any.

Tadalafil

• Brand patent expired in many jurisdictions around 2018.
• Generics now dominate the market, leading to significant price erosion.
• Market share protected by proprietary formulations and additional indications.

What are the key drivers and restraints shaping market growth?

Drivers

• Increasing prevalence of PAH, ED, and BPH globally.
• Advancements in formulation technology improving drug delivery.
• Growing awareness and diagnosis of pulmonary hypertension.
• Expansion into emerging markets with increasing healthcare penetration.

Restraints

• Patent expirations leading to price competition.
• Side effect profiles impacting patient adherence.
• Slow regulatory approval for new indications.
• Cost barriers in low-income regions.

What are the pricing trends and revenue forecasts?

Drug	Price per treatment course (approx.)	2023 Revenue Estimate	2028 Projected Revenue	Key Factors
Macitentan	$10,000-$15,000 (brand-specific)	$700 million	$900 million	Patent exclusivity, PAH prevalence
Tadalafil	$60-$120 (brand), $10-$30 (generic)	$3.2 billion	$2.8 billion	Patent loss, generic competition

Tadalafil’s revenue is declining due to generic erosion, but volume remains high. Macitentan’s revenue is expected to rise modestly, assuming patent protection persists.

How are R&D investments shaping future trajectories?

Investors and pharma companies are investing in:

• Macitentan: Combining with other PAH therapies to improve outcomes.
• Tadalafil: Developing formulations with sustained-release technology and exploring new pulmonary hypertension indications.

R&D expenditures are estimated at approximately $50-$100 million annually for each drug, focusing on efficacy, safety, and expanded indications.

How do market access and reimbursement policies impact revenue projections?

Reimbursement coverage varies:

• In developed countries, both drugs generally benefit from favorable reimbursement policies.
• Cost containment pressures and managed care programs restrict access and reduce sales margins.
• Emerging markets exhibit variable reimbursement but offer long-term growth due to increasing treatment rates.

What are the major risks in the financial outlook?

• Patent cliffs and the entry of generics reduce pricing power.
• Regulatory delays or unfavorable label updates can impair sales.
• Competitive innovations, such as new therapies for PAH or ED, may overshadow current drugs.
• Price controls in specific markets might compress revenue potential.

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Key Takeaways

• Tadalafil dominates revenue due to broader indications and global acceptance, although its market faces erosion from generics.
• Macitentan's growth relies heavily on continued patent protection and market penetration in PAH.
• Patent expiries will substantially influence future revenue streams, especially for tadalafil.
• Market expansion opportunities exist in emerging markets and for new indications.
• R&D trends focus on improving formulations and broadening therapeutic applications to sustain competitive advantage.

FAQs

1. What factors could accelerate the market growth for macitentan?
Expanding indications beyond PAH, such as chronic thromboembolic pulmonary hypertension (CTEPH), and increasing global prevalence of PAH could drive growth.

2. How does patent expiry affect tadalafil’s market share?
Patent expiry led to generic entry, significantly reducing prices and market revenue but maintained volume due to its efficacy and multiple indications.

3. Are there any upcoming regulatory approvals for these drugs?
No significant new approvals are currently anticipated for macitentan or tadalafil, but ongoing clinical trials may lead to new indications.

4. What competitive advantages can branded formulations keep in the face of generics?
Enhanced formulations, combination therapy capabilities, and expanding indications provide differentiation.

5. How will emerging markets influence future sales?
Growing healthcare infrastructure and increasing awareness of PAH, ED, and BPH can lead to rising treatment rates and revenue opportunities in Asia, Africa, and Latin America.

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Citations

[1] MarketWatch. "Global Pulmonary Hypertension Drugs Market." 2022.
[2] EvaluatePharma. "Pharmaceutical Sales Data." 2022.
[3] US FDA. "Drug Approvals and Labeling." 2013, 2009.
[4] IQVIA. "Global Trends in Pharmaceutical Markets." 2022.
[5] Statista. "Generic Drugs Market Data." 2023.