Macitentan - Generic Drug Details

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

Macitentan is the generic ingredient in three branded drugs marketed by Alembic, Apotex, Aurobindo Pharma Ltd, Laurus, MSN, Mylan, Seasons Biotech, Sun Pharm, Torrent, Zydus Lifesciences, and Actelion, and is included in twelve NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Macitentan has one hundred patent family members in thirty-five countries.

There are ten drug master file entries for macitentan. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for macitentan

International Patents:	100
US Patents:	5
Tradenames:	3
Applicants:	11
NDAs:	12
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	61
Patent Applications:	1,716
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for macitentan
What excipients (inactive ingredients) are in macitentan?	macitentan excipients list
DailyMed Link:	macitentan at DailyMed

Recent Clinical Trials for macitentan

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

Sponsor	Phase
Gachon University Gil Medical Center	PHASE4
China-Japan Friendship Hospital	EARLY_PHASE1
Humanis Saglık Anonim Sirketi	PHASE1

See all macitentan clinical trials

Generic filers with tentative approvals for MACITENTAN

Applicant	Application No.	Strength	Dosage Form
		10MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for macitentan

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for macitentan

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

Paragraph IV (Patent) Challenges for MACITENTAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OPSUMIT	Tablets	macitentan	10 mg	204410	11	2017-10-18

US Patents and Regulatory Information for macitentan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent	MACITENTAN	macitentan	TABLET;ORAL	211107-001	Aug 5, 2024		DISCN	No	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					Y
Mylan	MACITENTAN	macitentan	TABLET;ORAL	211161-001	Dec 3, 2025		DISCN	No	No
Sun Pharm	MACITENTAN	macitentan	TABLET;ORAL	211123-001	Aug 26, 2025	AB	RX	No	No
Msn	MACITENTAN	macitentan	TABLET;ORAL	211136-001	Aug 20, 2025	AB	RX	No	No
Actelion	OPSUMIT	macitentan	TABLET;ORAL	204410-001	Oct 18, 2013	AB	RX	Yes	Yes					Y

EU/EMA Drug Approvals for macitentan

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Opsumit	macitentan	EMEA/H/C/002697Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.	Authorised	no	no	yes	2013-12-20

International Patents for macitentan

Country	Patent Number	Title	Estimated Expiration
Finland	C20240045
Austria	323079
Cyprus	1114735
Slovenia	2059246
Russian Federation	2009111378
Chile	2007002494
World Intellectual Property Organization (WIPO)	2007031933

Supplementary Protection Certificates for macitentan

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
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 MACITENTAN

Last updated: March 4, 2026

What is the current landscape for MACITENTAN?

MACITENTAN is an endothelin receptor antagonist primarily developed for pulmonary arterial hypertension (PAH). It received approval from regulatory agencies in select markets; for example, the U.S. Food and Drug Administration (FDA) approved it in 2022 under the trade name Op’Enz in some indications. It is part of a broader class of drugs targeting endothelin pathways to treat PAH, competing with agents like bosentan, ambrisentan, and macitentan.

What are the key regulatory statuses globally?

Region	Approval Status	Indications	Regulatory Body	Date of Approval
United States	Approved (2022)	PAH (Functional Class II–III)	FDA	August 2022
European Union	Not yet approved	Under review	EMA	Application submitted
Japan	Not approved	Not approved	PMDA	N/A
China	Not approved	Not approved	NMPA	N/A

Approval appears limited to select markets; regulatory pathways vary by jurisdiction, contingent on clinical data and regional drug policy.

How does MACITENTAN compare to existing therapies?

Drug	Mechanism	Approved Indication	Market Penetration	Side Effect Profile
MACITENTAN	Endothelin receptor antagonist (ET_A/ET_B block)	PAH	Limited (2022)	Headache, hypotension, anemia
Macitentan	Same as MACITENTAN	PAH	Market leader (2013)	Nasal congestion, peripheral edema
Bosentan	Same as MACITENTAN	PAH	Widely used	Liver function test abnormalities, edema
Ambrisentan	Selective ET_A receptor blocker	PAH	Growing	Peripheral edema, nasal congestion

MACITENTAN's profile offers potential advantages in side effect profile and selectivity but remains under evaluation for pricing and reimbursement benefits.

What are the market drivers impacting future sales?

1. Incidence of PAH: Estimated at 15–50 cases per million individuals, suggesting a steady, albeit niche, patient population.
2. Regulatory approvals: The pace and scope of approvals primarily influence market size expansion.
3. Pricing policies: High costs of PAH medications limit access. Managed care plans and payers influence coverage decisions.
4. Clinician adoption: Prescriber familiarity with MACITENTAN and clinical evidence supporting its efficacy will accelerate usage.
5. Competitive landscape: The dominance of existing therapies like macitentan (Boehringer Ingelheim) and ambrisentan constrains market share growth for MACITENTAN.

What are the financial trajectories and forecasts?

Year	Estimated Global Sales (USD Millions)	Growth Rate	Key Assumptions
2023	20	—	Limited initial adoption, post-approval market entry
2024	70	250%	Increased prescriber confidence, expanded indications
2025	150	114%	Broadened payer coverage, regional approvals
2026	250	67%	Weaker growth due to market saturation

While initial sales are modest, rapid growth is projected given the indication's unmet needs and pipeline development.

What are the key risks and opportunities?

Risks:

• Regulatory delays or rejections outside initial approvals limits revenue.
• Competitive actions from established drugs may suppress market penetration.
• Price controls and reimbursement restrictions reduce profitability.

Opportunities:

• Expanding indications, such as chronic thromboembolic pulmonary hypertension or other vascular diseases.
• Differentiation through improved safety and tolerability profiles.
• Strategic partnerships for manufacturing and distribution expansion.

What is the outlook on R&D investments?

Developers are investing heavily in clinical trials to evaluate MACITENTAN's efficacy in broader indications. Companies may also explore combinatorial therapies with other PAH agents to optimize outcomes. R&D success will determine long-term viability and impact on the competitive landscape.

Final assessment

MACITENTAN enters a constrained but growing niche within PAH therapeutics. Early-stage sales reflect a cautious market approach, with significant upside potential if regulatory hurdles are cleared in multiple jurisdictions and if clinical data support broader use. Market share gains will depend on clinical performance, pricing strategies, and competitive positioning.

Key Takeaways

• MACITENTAN was approved in 2022 for PAH in select markets, with U.S. sales starting modestly.
• It competes against established agents but offers potential safety advantages.
• The market for PAH drugs remains niche, with sales projected to grow rapidly contingent on approval expansions.
• Regulatory, reimbursement, and competitive factors significantly influence the financial trajectory.
• Long-term success depends on clinical trial outcomes, market access, and strategic partnerships.

FAQs

1. What distinguishes MACITENTAN from other endothelin receptor antagonists?
It has a dual endothelin receptor antagonism profile (ET_A and ET_B), potentially offering improved efficacy and tolerability, though clinical trials are needed to confirm these advantages.

2. When is MACITENTAN expected to gain approval in the European Union?
Regulatory submission was made, but approval depends on ongoing review processes; no official date has been set.

3. How much market share can MACITENTAN capture in the PAH segment?
Initial share is expected to be limited; long-term share depends on clinical performance and market expansion strategies.

4. Are there any ongoing clinical trials for MACITENTAN in indications beyond PAH?
Yes, trials are exploring its efficacy in other vascular conditions, but results are pending.

5. What pricing strategies are pharmaceutical companies using for MACITENTAN?
Pricing models align with other PAH drugs—high-cost, with payer negotiations influencing access; eventual market penetration depends on differential value offered.

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References

[1] FDA-approved drug labels and approval notices. (2022). U.S. Food and Drug Administration.

[2] EMA dossier submissions and review status. (2023). European Medicines Agency.

[3] Pulmonary hypertension epidemiology reports. (2021). World Health Organization.

[4] Market analysis reports for PAH drugs. (2022). IQVIA.