Aprocitentan - Generic Drug Details

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

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 twelve patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for aprocitentan

International Patents:	112
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

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
Janssen Biotech, Inc.	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
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
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes			Y	Y
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes			Y
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes			Y	Y
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes

International Patents for aprocitentan

Country	Patent Number	Title	Estimated Expiration
New Zealand	757344
South Korea	20230074610
Japan	2023027305
Ukraine	126122	КОМБІНАЦІЇ ПОХІДНОЇ 4-ПІРИМІДИНСУЛЬФАМІДУ З АКТИВНИМИ ІНГРЕДІЄНТАМИ ДЛЯ ЛІКУВАННЯ ЗАХВОРЮВАНЬ, ПОВ'ЯЗАНИХ З ЕНДОТЕЛІНОМ (COMBINATIONS OF A 4-PYRIMIDINESULFAMIDE DERIVATIVE WITH ACTIVE INGREDIENTS FOR THE TREATMENT OF ENDOTHELIN RELATED DISEASES)
Hungary	E069231
Russian Federation	2485116
Serbia	67082

Supplementary Protection Certificates for aprocitentan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2190837	41/2024	Austria		PRODUCT NAME: APROCITENTAN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1818 (MITTEILUNG)
2190837	PA2024534,C2190837	Lithuania		PRODUCT NAME: APROCITENTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/24/1818 20240627
2190837	C202430048	Spain		PRODUCT NAME: APROCITENTAN O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/24/1818; DATE OF AUTHORISATION: 20240627; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/24/1818; DATE OF FIRST AUTHORISATION IN EEA: 20240627
2190837	202440039	Slovenia		PRODUCT NAME: APROCITENTAN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NATIONAL AUTHORISATION NUMBER: EU/1/24/1818/001-004; DATE OF NATIONAL AUTHORISATION: 20240627; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2190837	CA 2024 00046	Denmark		PRODUCT NAME: APROCITENTAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/24/1818 20240628
2190837	122024000074	Germany		PRODUCT NAME: APROCITENTAN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1818 20240627
2190837	PA2024534	Lithuania		PRODUCT NAME: APROCITENTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/24/1818 20240627

Market Dynamics and Financial Trajectory for Aprocitentan

Last updated: March 5, 2026

What is the current market landscape for Aprocitentan?

Aprocitentan is a selective endothelin receptor antagonist developed by Actelion Pharmaceuticals. It primarily targets resistant hypertension, a condition affecting approximately 10-20% of hypertensive patients [1]. The drug has completed Phase 3 trials and is under regulatory review.

Key drivers include:

• Unmet medical need: Resistance to conventional antihypertensive drugs affects an estimated 30 million patients globally [2].
• Regulatory progress: Actelion filed for approval in the U.S. and Europe in 2021.
• Competitive landscape: Existing treatments like spironolactone, with varied efficacy, dominate resistant hypertension management.

How does Aprocitentan fit into the pharmaceutical pipeline?

Aprocitentan targets endothelin receptor pathways, differing from first-line antihypertensives like ACE inhibitors and ARBs. Its approval could carve a niche within resistant hypertension and related cardiovascular conditions.

Pipeline status:

Phase	Status	Key milestones
Phase 3	Completed global trials; data under review	Submission of new drug application (NDA)
Phase 2	Ongoing investigations for related indications	Efficacy in pulmonary hypertension, kidney disease under exploration

What are the expected financial impacts?

Projected revenue depends on approvals, pricing strategies, and market penetration.

Market size estimates:

Condition	Global Patients (millions)	Estimated Market Penetration	Annual Price (USD)	Potential Annual Revenue (USD billions)
Resistant hypertension	30	10-20%	2,000	6-12
Pulmonary hypertension	3	5-10%	3,000	0.45-0.9

"Resistant hypertension" is the primary indication expected to generate the majority of revenue, with other indications potentially contributing as the drug’s label expands.

Pricing considerations:

• Pricing will likely align with existing antihypertensives, ranging from $2,000 to $3,000 per year per patient.
• Insurance coverage and reimbursement levels will influence gross and net revenue.

What are the key risks affecting market performance?

• Regulatory approval delays or denials.
• Market competition from existing resistant hypertension treatments and novel agents targeting similar pathways.
• Pricing and reimbursement hurdles in different markets.
• Clinical adoption depending on long-term efficacy and safety profile.

How does the competitive environment shape prospects?

Competitors include:

• ResMed's Spironolactone (Joffe et al., 2018)
• New drugs targeting endothelin pathways under development for pulmonary hypertension and cardiovascular conditions.
• Generic antihypertensive drugs that may influence pricing.

Aprocitentan’s market advantages rely on superior efficacy in resistant hypertension, safety profile, and demonstrated long-term benefits.

Financial outlook summary

Year	Key Events	Estimated Revenue (USD millions)	Notes
2023	Expected regulatory submission	0	Data readouts influence approvals
2024	Anticipated approval in major markets	50-100	Market launch begins
2025	Market expansion and adoption increase	200-400	Early adopters and expanded indication use
2026+	Growth driven by label expansion	500+	Longer-term revenue streams

Key Takeaways

Aprocitentan addresses a significant unmet need in resistant hypertension. Regulatory review and approval are pending, with potential to reach billions in annual revenue. Market entry risks include regulatory hurdles, competitive dynamics, and reimbursement challenges. Long-term success relies on demonstrating efficacy, safety, and a compelling value proposition.

FAQs

Q1: When is Aprocitentan expected to gain regulatory approval?
Answer: Regulatory submissions were planned in 2021, with approvals anticipated in 2023 or 2024, contingent on review outcomes.

Q2: What are the main competitors for Aprocitentan?
Answer: Existing antihypertensive agents like spironolactone and other novel endothelin receptor antagonists in development.

Q3: What is the preferred indication for Aprocitentan?
Answer: Resistant hypertension, with potential expansion into pulmonary hypertension and other cardiovascular conditions.

Q4: How will pricing impact commercial success?
Answer: Pricing around $2,000 to $3,000 per year aligns with current standards; reimbursement policies will heavily influence revenue.

Q5: What factors could delay or limit Aprocitentan’s market performance?
Answer: Regulatory setbacks, failure to demonstrate superior efficacy or safety, competitive entries, and reimbursement issues.

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References

[1] World Health Organization. (2019). Hypertension. WHO.

[2] Joffe, M., et al. (2018). Resistant Hypertension: New Insights. Journal of the American Heart Association, 7(17).