Daridorexant hydrochloride - Generic Drug Details

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

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

Daridorexant hydrochloride has eighty-eight patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for daridorexant hydrochloride

International Patents:	88
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	12
Patent Applications:	9
DailyMed Link:	daridorexant hydrochloride at DailyMed

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

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 daridorexant hydrochloride

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

Sponsor	Phase
Citeline	Phase 2
U.S. Army Medical Research and Development Command	Phase 2
Cambridge Cognition Ltd	Phase 2

See all daridorexant hydrochloride clinical trials

Pharmacology for daridorexant hydrochloride

Drug Class	Orexin Receptor Antagonist
Mechanism of Action	Orexin Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for daridorexant hydrochloride

N05CJ	Orexin receptor antagonists
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for daridorexant hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-002	Apr 7, 2022		RX	Yes	Yes			Y	Y
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-001	Apr 7, 2022		RX	Yes	No
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-001	Apr 7, 2022		RX	Yes	No			Y	Y
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-002	Apr 7, 2022		RX	Yes	Yes
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-001	Apr 7, 2022		RX	Yes	No			Y	Y
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-001	Apr 7, 2022		RX	Yes	No

International Patents for daridorexant hydrochloride

Country	Patent Number	Title	Estimated Expiration
Malaysia	169986	BENZIMIDAZOLE-PROLINE DERIVATIVES
Singapore	10201702540U	BENZIMIDAZOLE-PROLINE DERIVATIVES
Eurasian Patent Organization	201600436	КРИСТАЛЛИЧЕСКАЯ СОЛЕВАЯ ФОРМА (S)-(2-(6-ХЛОР-7-МЕТИЛ-1H-БЕНЗО[D]ИМИДАЗОЛ-2-ИЛ)-2-МЕТИЛПИРРОЛИДИН-1-ИЛ)(5-МЕТОКСИ-2-(2H-1,2,3-ТРИАЗОЛ-2-ИЛ)ФЕНИЛ)МЕТАНОНА И ЕЕ ПРИМЕНЕНИЕ В КАЧЕСТВЕ АНТАГОНИСТОВ ОРЕКСИНОВОГО РЕЦЕПТОРА
Slovenia	2855453
Hungary	E034656
Philippines	12016500989	CRYSTALLINE FORM OF (S)-(2-(6-CHLORO-7-METHYL-1H-BENZO[D]IMIDAZOL-2-YL)-2-METHYLPYRROLIDIN-1 -YL)(5-METHOXY-2-(2H-1,2,3-TRIAZOL-2-YL)PHENYL)METHANONE AS OREXIN RECEPTOR ANTAGONISTS

Supplementary Protection Certificates for daridorexant hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2855453	CA 2022 00041	Denmark		PRODUCT NAME: DARIDOREXANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SAERLIGT DARIDOREXANT HYDROCHLORID; REG. NO/DATE: EU/1/22/1638 20220502
2855453	301197	Netherlands		PRODUCT NAME: DARIDOREXANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER DARIDOREXANTHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1638 20220502
2855453	2022C/543	Belgium		PRODUCT NAME: DARIDOREXANT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE CHLORHYDRATE DE DARIDOREXANT; AUTHORISATION NUMBER AND DATE: EU/1/22/1638 20220502
2855453	2290037-7	Sweden		PRODUCT NAME: DARIDOREXANT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR DARIDOREXANT HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1638/001-006 20220502
2855453	22C1047	France		PRODUCT NAME: DARIDOREXANT OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE CHLORHYDRATE DE DARIDOREXANT; REGISTRATION NO/DATE: EU/1/22/1638 20220502
2855453	PA2022518	Lithuania		PRODUCT NAME: DARIDOREKSANTAS; REGISTRATION NO/DATE: 1/22/1638/001-006 20220429

Daridorexant hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Daridorexant Hydrochloride

Introduction

Daridorexant hydrochloride, marketed as QUVIVIQ, is a dual orexin receptor antagonist (DORA) designed to treat insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Here, we delve into the market dynamics and financial trajectory of this drug.

Mechanism of Action and Clinical Significance

Daridorexant works by antagonizing the activation of orexin receptors by orexin neuropeptides, which promotes wakefulness. By inhibiting these receptors, daridorexant decreases the wake drive, facilitating sleep[4].

Regulatory Approvals

Daridorexant has received regulatory approvals in several key markets. It was approved in the US in January 2022 and in Europe in April 2022. More recently, it was approved in Japan, with Idorsia Japan and Mochida Pharmaceutical Co., Ltd. jointly developing and marketing it in this region[1][4].

Market Performance

Global Sales

In the first nine months of 2024, QUVIVIQ generated total product sales of CHF 39 million across various countries, including the US, Germany, Italy, Switzerland, Spain, UK, Canada, Austria, and France. This represents a significant increase from the previous year, particularly in the US where net sales reached CHF 21 million, a 41% increase compared to the first nine months of 2023[2].

Patient and Prescription Metrics

As of the end of the third quarter of 2024, more than 165,000 patients in the US have been treated with QUVIVIQ since its launch, with over 500,000 prescriptions dispensed. The drug has been prescribed by almost 50,000 healthcare professionals, indicating strong adoption within the medical community[2].

Commercial Partnerships

Idorsia has established several commercial partnerships to enhance the market reach of QUVIVIQ. For instance, a sales partnership agreement was entered into with Shionogi and Mochida Pharmaceutical Co., Ltd. in Japan to expand treatment options for insomnia. Additionally, Idorsia has a commercial partnership with Menarini France to further distribute QUVIVIQ in the European market[1][2].

Financial Performance of Idorsia

Revenue and Operating Loss

In the first nine months of 2024, Idorsia reported net revenues of CHF 53 million, primarily driven by QUVIVIQ sales. However, the company also reported a US GAAP operating loss of CHF 154 million and a non-GAAP operating loss of CHF 248 million. Despite these losses, Idorsia has improved its financial guidance for 2024, attributing this to diligent cost control measures[2].

Liquidity and Indebtedness

As of September 30, 2024, Idorsia had cash and cash equivalents of CHF 92 million. The company's total indebtedness stood at CHF 1,294 million, including a convertible loan and convertible bond[2].

Market Growth Potential

The insomnia treatment market is growing, driven by increasing awareness and the need for effective treatments. Daridorexant's unique mechanism of action as a DORA positions it well in this market. The drug's approval in multiple regions and the establishment of commercial partnerships suggest a strong potential for continued market growth.

Competitive Landscape

Daridorexant competes in a market that includes other insomnia treatments, but its dual orexin receptor antagonist mechanism sets it apart. The drug's efficacy and safety profile, as demonstrated in Phase III clinical trials, are key factors in its competitive advantage[1][4].

Future Outlook

Idorsia's efforts to ramp up sales of QUVIVIQ, combined with the expansion of marketing authorization in various regions, indicate a positive future outlook. The company's focus on cost control and strategic partnerships is expected to support the drug's continued market penetration.

"Making progress in ramping up sales of QUVIVIQ, making TRYVIO available in the US, and expanding marketing authorization for JERAYGO,” - André C. Muller, Chief Executive Officer of Idorsia[2].

Key Takeaways

• Regulatory Approvals: Daridorexant has been approved in the US, Europe, and Japan.
• Sales Performance: QUVIVIQ generated CHF 39 million in sales in the first nine months of 2024, with a 41% increase in US sales.
• Commercial Partnerships: Partnerships with Shionogi, Mochida, and Menarini France to enhance market reach.
• Financial Performance: Idorsia reported a US GAAP operating loss but improved financial guidance due to cost control.
• Market Growth Potential: Strong potential driven by the growing insomnia treatment market and the drug's unique mechanism.

FAQs

What is daridorexant hydrochloride used for?

Daridorexant hydrochloride, marketed as QUVIVIQ, is used for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance[4].

Who are the key partners involved in the marketing of QUVIVIQ in Japan?

In Japan, QUVIVIQ is jointly marketed by Idorsia Japan, Mochida Pharmaceutical Co., Ltd., and Shionogi & Co., Ltd.[1].

How has QUVIVIQ performed in terms of sales in 2024?

In the first nine months of 2024, QUVIVIQ generated total product sales of CHF 39 million, with a 41% increase in US sales compared to the same period in 2023[2].

What is the mechanism of action of daridorexant?

Daridorexant works by antagonizing the activation of orexin receptors by orexin neuropeptides, which promotes wakefulness, thereby facilitating sleep[4].

How many patients have been treated with QUVIVIQ in the US since its launch?

As of the end of the third quarter of 2024, more than 165,000 patients in the US have been treated with QUVIVIQ since its launch[2].

Sources

1. Shionogi & Co., Ltd. - Announcement of the Sales Partnership Agreement in Japan between Shionogi and Mochida regarding Insomnia Treatment Drug Daridorexant.
2. Idorsia Ltd - Financial results for the first nine months of 2024.
3. Shionogi Integrated Report 2023 - Financial KPIs and Expansion of Products.
4. Health Canada - Summary Basis of Decision for Quviviq.