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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aprocitentan has ninety-one patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for aprocitentan

International Patents:	91
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	8
Patent Applications:	42
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
Actelion	Phase 1
Idorsia Pharmaceuticals Ltd.	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			Y	Y
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
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes

International Patents for aprocitentan

Country	Patent Number	Title	Estimated Expiration
Canada	3053991	COMBINAISONS D'UN DERIVE DE 4-PYRIMIDINESULFAMIDE AVEC DES PRINCIPES ACTIFS POUR LE TRAITEMENT DE MALADIES LIEES A L'ENDOTHELINE (COMBINATIONS OF A 4-PYRIMIDINESULFAMIDE DERIVATIVE WITH ACTIVE INGREDIENTS FOR THE TREATMENT OF ENDOTHELIN RELATED DISEASES)
Taiwan	200927122	4-pyrimidinesulfamide derivative
Japan	7223701
Mexico	2019010221	FORMAS CRISTALINAS DEL DERIVADO DE 4-PIRIMIDINSULFAMIDA APROCITENTAN. (CRYSTALLINE FORMS OF THE 4-PYRIMIDINESULFAMIDE DERIVATIVE APROCITENTAN.)
South Korea	102568472
China	117946011	4-嘧啶磺酰胺衍生物的结晶形式 (Crystalline forms of 4-pyrimidine sulfonamide derivatives)
Russian Federation	2485116	ПРОИЗВОДНЫЕ 4-ПИРИМИДИНСУЛЬФАМИДА (4-PYRIMIDINESULPHAMIDE DERIVATIVE)

Supplementary Protection Certificates for aprocitentan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2190837	C20240041	Finland
2190837	2024C/545	Belgium		PRODUCT NAME: APROCITENTAN OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/24/1818 20240628
2190837	301304	Netherlands		PRODUCT NAME: APROCITENTAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/24/1818 20240628
2190837	CR 2024 00046	Denmark		PRODUCT NAME: APROCITENTAN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/24/1818 20240628
2190837	PA2024534	Lithuania		PRODUCT NAME: APROCITENTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION 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

Market Dynamics and Financial Trajectory for Aprocitentan

Introduction

Aprocitentan, an oral, dual endothelin receptor antagonist, is a groundbreaking drug developed by Idorsia for the treatment of resistant hypertension. Here, we delve into the market dynamics and financial trajectory of this innovative therapy.

Regulatory Status

Aprocitentan is currently under review by health authorities in the US and Europe. The new drug application (NDA) was filed with the US FDA in December 2022, with a Prescription Drug User Fee Act (PDUFA) date set for December 19, 2023. The market authorisation application (MAA) was submitted to the European Medicines Agency (EMA) at the end of January 2023[1][4].

Clinical Significance

Aprocitentan has demonstrated significant and clinically meaningful sustained blood pressure lowering benefits with a good safety profile. The PRECISION study, a Phase 3 trial, published its full results in November 2022 in The Lancet, highlighting the drug's efficacy in treating patients with resistant hypertension[4][5].

Reacquisition of Rights

In September 2023, Idorsia reacquired the worldwide development and commercialization rights for aprocitentan from Janssen Biotech Inc. This agreement involves Idorsia paying Janssen a conditional consideration up to a total cap of CHF 306 million, contingent on Idorsia’s revenues and specific milestones[1][4].

Financial Implications

The reacquisition of aprocitentan's rights is expected to provide Idorsia with more strategic flexibility and potentially allow Janssen to recoup their investment over time. The conditional payment structure includes:

• 30% of any consideration received by Idorsia from a potential out-licensing or divestment of aprocitentan.
• 10% of any consideration received by Idorsia from a potential out-licensing or the divestment of any other Idorsia product, following the first approval of aprocitentan.
• Low- to mid-single digit royalties on total group product net sales, beginning from the quarter after the first aprocitentan approval[4].

Market Potential

Aprocitentan addresses a significant and growing public health problem – resistant hypertension. Given its novel mechanism of action, which is the first new approach in 30 years, the drug has substantial market potential. Idorsia is actively engaging with potential partners to launch this innovative product, aiming to maximize its value[2][4].

Competitive Landscape

The hypertension market is highly competitive, but aprocitentan's unique mechanism of action and favorable safety profile position it as a promising addition. The drug's low potential for drug-drug interactions further enhances its appeal, particularly for high-risk patient populations[4].

Financial Performance of Idorsia

Idorsia's financial performance is closely tied to the success of its products, including aprocitentan. For the first half of 2024, Idorsia reported a net revenue of CHF 26 million, primarily driven by sales of QUVIVIQ (daridorexant) and contract revenue. The company expects to continue controlling expenses and is optimistic about the revenue potential of aprocitentan once it is approved and launched[2].

Cost Containment and Funding

Idorsia has been focusing on cost containment and optimizing its financial structure. The company has taken several steps, including the Viatris deal and restructuring its convertible bonds, to ensure it has the necessary resources to support the launch of aprocitentan. As of the end of the first half of 2024, Idorsia's liquidity amounted to CHF 237 million[2].

Launch Preparation

Idorsia is currently preparing for the launch of aprocitentan, engaging in activities to determine the best approach to maximize the drug's value. This includes evaluating partnership opportunities and ensuring all necessary regulatory and commercial materials are in place[1][4].

Expert Insights

Jean-Paul Clozel, CEO of Idorsia, emphasized the significance of aprocitentan: "Aprocitentan has demonstrated significant and clinically meaningful sustained blood pressure lowering benefits with a good safety profile, particularly suited to the high-risk patient population with resistant hypertension."[1][4]

André C. Muller, Chief Financial Officer, noted: "If aprocitentan is approved in the US and Europe as we expect, Idorsia would have an additional product in its portfolio giving the company more strategic flexibility, and potentially allows Janssen to recoup over time their investment in aprocitentan."[4]

Key Takeaways

• Regulatory Approval: Aprocitentan is under review by the US FDA and EMA, with expected approvals in late 2023.
• Clinical Efficacy: The drug has shown significant blood pressure lowering benefits with a good safety profile.
• Financial Structure: Idorsia will pay Janssen up to CHF 306 million in conditional consideration.
• Market Potential: Aprocitentan addresses a growing public health issue with a novel mechanism of action.
• Launch Preparation: Idorsia is actively preparing for the drug's launch, including evaluating partnership opportunities.

FAQs

What is aprocitentan and how does it work?

Aprocitentan is an oral, dual endothelin receptor antagonist designed to treat resistant hypertension. It works by blocking the action of endothelin, a potent vasoconstrictor, thereby lowering blood pressure.

What is the current regulatory status of aprocitentan?

Aprocitentan is currently under review by the US FDA and the European Medicines Agency (EMA), with regulatory decisions expected in late 2023.

How much will Idorsia pay Janssen for the rights to aprocitentan?

Idorsia will pay Janssen a conditional consideration up to a total cap of CHF 306 million, contingent on specific revenue milestones.

What are the financial implications of aprocitentan for Idorsia?

The approval and launch of aprocitentan are expected to provide Idorsia with additional revenue streams and more strategic flexibility, potentially enhancing the company's financial performance.

How does aprocitentan compare to other hypertension treatments?

Aprocitentan offers a novel mechanism of action, the first new approach in 30 years, and has a favorable safety profile with low potential for drug-drug interactions, making it a promising addition to the hypertension treatment landscape.

Sources

1. Idorsia - Idorsia reacquires the world-wide rights to aprocitentan - September 6, 2023
2. BioSpace - Idorsia announces financial results for the first half 2024 - July 25, 2024
3. NTB Kommunikasjon - Idorsia announces financial results for 2022 – building momentum to become a leading mid-sized biopharmaceutical company - February 7, 2023
4. GlobeNewswire - Idorsia reacquires the world-wide rights to aprocitentan - September 6, 2023
5. Idorsia - Idorsia announces financial results for the first nine months of 2022 - October 25, 2022

Last updated: 2024-12-16