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:	19
Patent Applications:	12
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
University of Utah	PHASE4
Massachusetts General Hospital	PHASE4
Brigham and Women's Hospital	PHASE4

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
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	214985-002	Apr 7, 2022		RX	Yes	Yes			Y	Y
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
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-002	Apr 7, 2022		RX	Yes	Yes			Y	Y

International Patents for daridorexant hydrochloride

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2855453	DÉRIVÉS DE BENZIMIDAZOLE-PROLINE (BENZIMIDAZOLE-PROLINE DERIVATIVES)
Eurasian Patent Organization	029899	ПРОИЗВОДНЫЕ БЕНЗИМИДАЗОЛ-ПРОЛИНА (BENZIMIDAZOLE-PROLINE DERIVATIVES)
Hong Kong	1225736	(S)-(2-(6-氯-7-甲基-1H-苯並[D]咪唑-2-基)-2-甲基吡咯烷-1-基)(5-甲氧基-2-(2H-1，2，3-三唑-2-基)苯基)甲酮作為食欲素受體拮抗劑的結晶鹽形式 (CRYSTALLINE SALT FORM OF (S)-(2-(6-CHLORO-7-METHYL-1 H-BENZO[D]IMIDAZOL-2-YL)-2-METHYLPYRROLIDIN-1 -YL)(5-METHOXY-2-(2H-1,2,3-TRIAZOL-2-YL)PHENYL)METHANONE AS OREXIN RECEPTOR ANTAGONIST)
Eurasian Patent Organization	201600436
Cyprus	1118735
Hungary	S2200040
South Korea	20160093683	오렉신 수용체 길항제로서의 (Ｓ)-(２-(６-클로로-７-메틸-１Ｈ-벤조[Ｄ]이미다졸-２-일)-２-메틸피롤리딘-１-일)(５-메톡시-２-(２Ｈ-１,２,３-트리아졸-２-일)페닐)메타논의 결정성 염 형태 (CRYSTALLINE SALT 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 ANTAGONIST)

Supplementary Protection Certificates for daridorexant hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2855453	CR 2022 00041	Denmark		PRODUCT NAME: DARIDOREXANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SAERLIGT DARIDOREXANT HYDROCHLORID; REG. NO/DATE: EU/1/22/1638 20220502
2855453	C02855453/01	Switzerland		PRODUCT NAME: DARIDOREXANTUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68481 01.12.2022
2855453	PA2022518	Lithuania		PRODUCT NAME: DARIDOREKSANTAS; REGISTRATION NO/DATE: 1/22/1638/001-006 20220429
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	36/2022	Austria		PRODUCT NAME: DARIDOREXANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE DARIDOREXANTHYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1638 (MITTEILUNG) 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	LUC00279	Luxembourg		PRODUCT NAME: DARIDOREXANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE CHLORHYDRATE DE DARIDOREXANT; AUTHORISATION NUMBER AND DATE: EU 1/22/1638 20220502

Market Dynamics and Financial Trajectory for DARIDOREXANT HYDROCHLORIDE

Last updated: July 28, 2025

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Introduction

Daridorexant hydrochloride, marketed as Quviviq® by Idorsia Pharmaceuticals, represents a significant advancement in the novel class of orexin receptor antagonists targeting insomnia. Since its regulatory approval in the United States by the FDA in January 2022, the drug’s market dynamics and projected financial trajectory have garnered considerable interest among pharmaceutical stakeholders, investors, and clinicians. This analysis explores the factors shaping its market environment, growth potential, competitive landscape, and revenue outlook, providing critical insights into its commercial viability.

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Market Overview: Insomnia and the Role of Daridorexant

Insomnia affects approximately 10% to 30% of adults globally, with chronic forms impairing daily functioning and increasing cardiovascular, metabolic, and psychiatric risks [1]. The unmet medical need for effective, well-tolerated sleep aids remains substantial. Traditional medications, such as benzodiazepines and non-benzodiazepine hypnotics (Z-drugs), have faced criticism due to dependence potential, residual sedation, and cognitive impairment.

In this context, Daridorexant’s mechanism—selective orexin receptor antagonism—offers a novel, potentially safer alternative. Its efficacy in improving sleep onset and maintenance, coupled with a favorable safety profile, positions it favorably in an expanding insomnia drug market estimated to reach USD 4 billion globally by 2025 [2].

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Market Dynamics

1. Competitive Landscape

Daridorexant enters a market historically dominated by Z-drugs like zolpidem, eszopiclone, and zaleplon, with newer agents such as lemborexant (Lunesta) also competing. The primary competition stems from devices and therapies in the sleep disorder spectrum, including behavioral interventions and emerging pharmacological agents targeting different pathways (e.g., melatonin receptor agonists).

Lemborexant, approved in 2019, is currently Daridorexant’s closest competitor—both targeting orexin pathways with similar indications. However, regulatory approvals, safety profiles, and clinician acceptance influence market share shifts. Daridorexant’s differentiated profile, notably its rapid onset and longer half-life suited for both sleep onset and maintenance, positions it as an attractive alternative.

2. Regulatory and Clinical Adoption

Initial FDA approval in early 2022 set the stage for entry. Subsequent approvals in Europe and Japan extend geographic reach, underpinning broader adoption. Clinician acceptance hinges on comprehensive head-to-head data, post-marketing surveillance, and competitive pricing strategies. Real-world evidence supporting safety and efficacy will further accelerate physician prescribing behaviors.

3. Pricing and Reimbursement

Pricing strategies impact market penetration and financial growth. Given the premium nature of novel sleep aids, Daridorexant is priced higher than generic alternatives but remains competitively positioned against other branded agents. Reimbursement policies by insurers and national health systems influence prescription volume; favorable coverage accelerates market penetration.

4. Patient Segments and Distribution Channels

Target populations include adults with chronic insomnia across age groups, especially those contraindicated for standard hypnotics due to comorbidities or risk profiles. Distribution channels encompass specialty clinics, general practitioners, and pharmacy chains. Telehealth platforms have also expanded reach, particularly during the COVID-19 pandemic.

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Financial Trajectory and Revenue Projections

1. Revenue Forecasts

Early-stage revenue estimations, based on market size, anticipated penetration, and pricing, project US sales of approximately USD 200-300 million by 2024–2025, with potential to surpass USD 500 million by 2027 as adoption expands. Factors influencing revenue include:

• Market Penetration: Initial uptake within specialized sleep clinics, progressing to broader primary care.

• Generic Competition: Introduction of generics for existing sleep medications could pressure pricing.

• Line Extensions: Potential development of formulations with prolonged effects or combination therapies can diversify revenue streams.

2. Factors Driving Growth

The following elements underpin revenue growth:

• Regulatory Approvals enable market access in major territories, including the US, Europe, and Asia.

• Increasing prevalence of insomnia boosts demand.

• Positive clinical data and post-market studies bolster prescriber confidence.

• Strategic marketing and pricing ensure competitive positioning.

3. Challenges and Risks

Risks include:

• Regulatory delays or rejections in emerging markets.

• Emergence of competing compounds or reformulations.

• Safety concerns arising from post-market surveillance may affect adoption.

• Pricing pressures from payers demanding cost-effective treatments.

4. Investment Considerations

For investors, Daridorexant’s trajectory exhibits moderate growth potential, contingent upon market penetration, clinical acceptance, and competitive dynamics. Early revenue streams offer reassurance, but long-term scalability depends on securing a substantial market share amid evolving therapeutic options.

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Global Market Expansion

Emerging markets in Asia, Latin America, and the Middle East offer significant growth prospects. Regulatory approvals in these regions are ongoing, with local healthcare infrastructure and reimbursement models influencing timelines. Collaborations with regional distributors can accelerate penetration.

Furthermore, research into expanding Daridorexant’s indications—such as narcolepsy or shift-work disorder—may diversify revenue streams, though such developments remain speculative.

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Conclusion

Daridorexant hydrochloride positions itself as a promising contender in the sleep disorder pharmaceutical landscape. Its innovative mechanism, robust clinical profile, and expanding regulatory footprint underpin a cautiously optimistic financial trajectory. The market's evolution will depend on competitive positioning, narrative-building around safety and efficacy, and strategic market access initiatives. Pharmaceutical companies and investors should monitor post-market data and regional approval progress to refine long-term strategic planning.

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Key Takeaways

• Market Entry and Positioning: Daridorexant entered a competitive market with a novel mechanism, gaining key regulatory approvals in the US and other territories, facilitating initial market access.

• Revenue Potential: Early estimates project USD 200–300 million in US sales by 2024–2025, with potential growth as clinical acceptance broadens.

• Competitive Dynamics: Its differentiators over existing therapies include safety profile and dual sleep onset/maintenance efficacy, but ongoing competition from existing orexin antagonists and generics remains a challenge.

• Global Expansion: Success in emerging markets hinges on regional regulatory timelines and reimbursement structures, with expansion strategies critical for sustained growth.

• Risks and Opportunities: Safety signals, pricing pressures, and competitive innovations form key risk factors; conversely, expanding indications and formulations could unlock further revenue streams.

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FAQs

1. What distinguishes Daridorexant from other insomnia medications?
Daridorexant is a selective orexin receptor antagonist, offering a novel mechanism that targets wakefulness pathways, potentially reducing dependence risks associated with traditional hypnotics.

2. What is the market outlook for Daridorexant over the next five years?
The drug’s revenue is projected to grow steadily, with estimates reaching USD 300–500 million within five years, driven by expanding indications, geographic presence, and increased clinical adoption.

3. How do competitive drugs like lemborexant impact Daridorexant’s market share?
They serve as direct competitors; Daridorexant’s differentiators—such as onset, duration, and safety profile—will determine its market share relative to these agents.

4. What regulatory hurdles remain for Daridorexant in global markets?
While approved in the US, Daridorexant’s expansion into Europe, Asia, and other regions depends on regional regulatory reviews, which could delay market entry or influence formulation approvals.

5. Are there potential secondary indications for Daridorexant?
Research is ongoing into broader sleep-wake disorders, but currently, its focus remains on adult insomnia. Future approvals for additional indications could significantly boost its market potential.

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References

[1] World Health Organization. "Insomnia: Epidemiology and Impact." WHO Reports, 2021.
[2] Grand View Research. "Sleep Disorder Drugs Market Size & Trends," 2022.