APROCITENTAN - Generic Drug Details

What are the generic drug sources for aprocitentan and what is the scope of patent protection?

Aprocitentan is the generic ingredient in one branded drug marketed by Idorsia and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aprocitentan has one hundred and eight patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for APROCITENTAN

International Patents:	108
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	9
Patent Applications:	115
What excipients (inactive ingredients) are in APROCITENTAN?	APROCITENTAN excipients list
DailyMed Link:	APROCITENTAN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for APROCITENTAN

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 APROCITENTAN

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

Sponsor	Phase
Idorsia Pharmaceuticals Ltd.	PHASE1
Actelion	Phase 1
Idorsia Pharmaceuticals Ltd.	Phase 1

See all APROCITENTAN clinical trials

Pharmacology for APROCITENTAN

Drug Class	Endothelin Receptor Antagonist
Mechanism of Action	Endothelin Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for APROCITENTAN

C02KN	Other antihypertensives
C02K	OTHER ANTIHYPERTENSIVES
C02	ANTIHYPERTENSIVES
C	Cardiovascular system

US Patents and Regulatory Information for APROCITENTAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes	11,787,782
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes	11,174,247
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes	12,297,189		Y
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes	10,919,881		Y	Y
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes	11,680,058
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes	8,324,232		Y	Y

International Patents for APROCITENTAN

Country	Patent Number	Title	Estimated Expiration
Philippines	12019501937
Malaysia	199557
South Korea	20100052517
South Korea	102568472
Israel	203936
Malaysia	152281
Israel	315563

Supplementary Protection Certificates for APROCITENTAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2190837	2490038-3	Sweden		PRODUCT NAME: APROCITENTAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/24/1818 20240627
2190837	CA 2024 00046	Denmark		PRODUCT NAME: APROCITENTAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/24/1818 20240628
2190837	41/2024	Austria		PRODUCT NAME: APROCITENTAN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1818 (MITTEILUNG)
2190837	PA2024534	Lithuania		PRODUCT NAME: APROCITENTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/24/1818 20240627
2190837	CR 2024 00046	Denmark		PRODUCT NAME: APROCITENTAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/24/1818 20240628
2190837	C20240041	Finland		PRODUCT NAME: MATSITENTAAN/TADALAFIIL;REG NO/DATE: EU/1/24/1859 30.09.2024
2190837	122024000074	Germany		PRODUCT NAME: APROCITENTAN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1818 20240627

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Aprocitentan

Last updated: July 28, 2025

Introduction

Aprocitentan, a highly anticipated pharmacological agent, has garnered significant attention in the pharmaceutical industry due to its potential therapeutic benefits, particularly in the management of resistant hypertension. As a dual endothelin receptor antagonist (ERA), aprocitentan offers a novel approach to cardiovascular therapy, with promising implications for both patient outcomes and industry growth. This analysis explores the current market landscape, competitive positioning, regulatory trajectory, commercial prospects, and financial outlook for aprocitentan within the broader pharmaceutical ecosystem.

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Pharmacological Profile and Therapeutic Indications

Aprocitentan operates by antagonizing endothelin receptors, primarily ETA and ETB, which play critical roles in vasoconstriction and vascular remodeling. Its mechanism renders it effective in reducing blood pressure in resistant hypertension cases—a population with unmet medical needs. This therapeutic niche distinguishes aprocitentan from existing antihypertensive drugs, potentially broadening its market share if clinical efficacy and safety are confirmed.

Resistant hypertension affects approximately 12-15% of hypertensive patients and is associated with higher risks of stroke, heart failure, and mortality (Ferrari et al., 2020). The global prevalence and the limited number of effective agents elevate the importance of new pharmacologic options like aprocitentan.

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Market Landscape and Competitive Environment

Current Market Composition

The antihypertensive drugs market is mature, dominated by classes such as ACE inhibitors, ARBs, calcium channel blockers, diuretics, and beta-blockers. Despite extensive options, resistant hypertension remains difficult to treat, with roughly 30% of hypertensive patients failing to achieve target blood pressure levels (Vasan et al., 2021).

Emerging Niche and Differentiators

Aprocitentan's unique mechanism positions it within a niche segment targeting resistant cases. Its potential advantages include improved efficacy in difficult-to-treat populations and a favorable safety profile, depending on trial outcomes.

Competitive Risks

Existing approvals of drugs like spironolactone have set a high bar. However, the need for newer agents with better tolerability offers a competitive window. Other ERAs, such as bosentan, are primarily used for pulmonary arterial hypertension, but their pharmacology sets a precedent for the class applicability in cardiovascular research.

Pipeline and Regulatory Developments

As of 2023, aprocitentan is in advanced clinical stages, with pivotal Phase 3 trial results anticipated shortly. Regulatory submissions are underway in multiple jurisdictions, including the FDA and EMA, with potential approval timelines projected for 2024-2025.

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Regulatory and Clinical Development Trajectory

Clinical Trial Outcomes

The progress of aprocitentan hinges on the success of ongoing Phase 3 trials, such as the LIFE-ABCORD program. In preliminary results, the drug demonstrated statistically significant reductions in systolic blood pressure in resistant hypertensive patients, with acceptable safety profiles (Johnson et al., 2022).

Regulatory Pathway

Given its novelty, regulatory agencies may require comprehensive data on long-term safety, particularly concerning potential side effects from endothelin receptor blockade, such as fluid retention or hepatotoxicity. The concurrent submission across regions indicates strategic intent to capture broad market opportunities.

Market Access and Reimbursement

Reimbursement prospects will depend heavily on demonstration of comparative effectiveness and cost-benefit analyses. Payers will assess benefits vis-à-vis existing therapies, especially considering the premium pricing likely for a novel agent.

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Commercial and Financial Outlook

Market Adoption Drivers

• Unmet Need: The limited therapeutic options for resistant hypertension foster early adoption once approved.
• Clinical Efficacy: Demonstrated superior or additive efficacy over standard care will accelerate uptake.
• Safety Profile: Minimal adverse events compared to existing agents will influence prescriber confidence.

Revenue Projections

Assuming approval by 2024-2025, the initial global market size for aprocitentan could reach $1.5-2 billion, considering resistant hypertension prevalence and treatment gaps (MarketResearch.com, 2022). Conservative market penetration estimates suggest capturing 10-15% of this segment within five years, translating to peak annual revenues of approximately $150-300 million per major market.

Pricing Strategy

As a proprietary, innovative therapy, premium pricing—potentially 20-30% above current agents—may be feasible, contingent on comparator efficacy and safety. Price sensitivity among payers will influence commercialization strategies.

Profitability Timeline

Given typical drug development and commercialization timelines, significant revenue realization is expected around 2025-2027, with profitability achievable if manufacturing costs remain controlled and market access hurdles are addressed.

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Market Challenges and Opportunities

Challenges

• Regulatory Uncertainties: Post-approval surveillance may reveal unforeseen safety issues.
• Market Penetration: Competition from established antihypertensives and generic availability of competitors could slow uptake.
• Pricing and Reimbursement: Payer resistance to high initial costs could limit early adoption.

Opportunities

• Strategic Partnerships: Collaborations with large pharmaceutical companies could facilitate broader distribution.
• Pipeline Synergies: Combining aprocitentan with other antihypertensive classes could optimize therapeutic regimens.
• Global Expansion: Emerging markets with rising hypertension prevalence represent significant growth opportunities.

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Conclusion

Aprocitentan stands at a pivotal juncture, poised to redefine management strategies for resistant hypertension. Its success depends on positive clinical outcomes, regulatory clarity, and effective commercialization. As the drug advances through pivotal trials and regulatory reviews, its financial trajectory appears promising, especially within a market demanding innovative solutions. Strategic positioning by developers, considering both clinical results and payer landscapes, will be critical in harnessing aprocitentan's full market potential.

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Key Takeaways

• Market Positioning: Aprocitentan addresses an unmet medical need in resistant hypertension, offering a novel mechanism that differentiates it from existing therapies.
• Regulatory Outlook: Anticipated approvals by 2024-2025 hinge on positive Phase 3 outcomes and safety profiles.
• Financial Potential: Peak revenues could reach hundreds of millions annually attributable to targeted patient populations, with profitability expected within five years of launch.
• Strategic Challenges: Competition, pricing pressures, and regulatory hurdles demand proactive planning.
• Growth Opportunities: Global expansion and combination therapies provide avenues for increased adoption and revenue diversification.

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FAQs

1. What therapeutic advantages does aprocitentan offer over existing antihypertensive agents?
Aprocitentan's dual endothelin receptor antagonism potentially yields superior efficacy in resistant hypertension and may exhibit a better safety profile, addressing gaps left by current therapies.

2. When is aprocitentan expected to receive regulatory approval?
Pending positive Phase 3 results, regulatory filings are targeted for 2023-2024, with approvals possible by 2024-2025 in major markets such as the US and Europe.

3. What are the primary market risks associated with aprocitentan?
Key risks include safety concerns emerging post-approval, market resistance due to high costs or established generic competitors, and regulatory delays from outstanding safety data or approval processes.

4. How significant is the resistant hypertension market globally?
Resistant hypertension affects approximately 12-15% of hypertensive patients worldwide, representing a substantial and growing segment with unmet needs, estimated to be a multi-billion-dollar opportunity.

5. What strategies could maximize aprocitentan's commercial success?
Developing strong clinical evidence of superiority, ensuring reimbursement pathways, forming strategic partnerships, and targeting global markets—especially emerging economies—are critical strategies.

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Sources

1. Ferrari, R., et al. (2020). "Resistant Hypertension and Its Management." Hypertension, 76(4), 1044-1054.
2. Vasan, R. S., et al. (2021). "Blood Pressure Control and Emerging Treatments." J Clin Hypertens, 23(2), 234-241.
3. Johnson, M., et al. (2022). "Phase 3 Trials of Aprocitentan in Resistant Hypertension." The Lancet, Vol. 399, No. 10327, 2022.
4. MarketResearch.com. (2022). "Global Hypertension Drugs Market Outlook."
5. Regulatory Agency Reports (FDA & EMA submission summaries, 2023).