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:	21
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
Washington State University	PHASE4
Legacy Health System	PHASE4
Henry Ford Health System	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	214985-001	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	214985-001	Apr 7, 2022		RX	Yes	No
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
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-001	Apr 7, 2022		RX	Yes	No			Y	Y

International Patents for daridorexant hydrochloride

Country	Patent Number	Title	Estimated Expiration
Singapore	10201702540U	BENZIMIDAZOLE-PROLINE DERIVATIVES
Malaysia	176244	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
Morocco	20150282	Dérivés de benzimidazole-proline
Morocco	39164	Forme de sel cristalline de (s)-(2-(6-chloro-7-méthyl-1 h-benzo[d]imidazol- 2-yl)-2-méthylpyrrolidin-1-yl)(5-méthoxy-2-(2h-1,2,3-triazol-2-yl)phényl)méthanone comme antagoniste des récepteurs à l'oréxine
Portugal	2855453
South Korea	20160088439	벤즈이미다졸-프롤린 유도체 (BENZIMIDAZOLE-PROLINE DERIVATIVES)
Mexico	2016007216	FORMA DE SAL CRISTALINA DE (S)-(2-(6-CLORO-7-METIL-1H-BENZO[D]IMID AZOL-2-IL)-2-METIL-PIRROLIDIN-1-IL) (5-METOXI-2-(2H-1,2,3-TRIAZOL- 2-IL)FENIL) METANONA COMO ANTAGONISTAS DE RECEPTOR DE OREXINA. (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.)

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	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	301197	Netherlands		PRODUCT NAME: DARIDOREXANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER DARIDOREXANTHYDROCHLORIDE; REGISTRATION NO/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
2855453	C02855453/01	Switzerland		PRODUCT NAME: DARIDOREXANTUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68481 01.12.2022
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	122022000059	Germany		PRODUCT NAME: DARIDOREXANT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE DARIDOREXANT-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1638 20220429

Daridorexant hydrochloride Market Analysis and Financial Projection

Last updated: February 13, 2026

What Is the Market Position and Demand for Daridorexant Hydrochloride?

Daridorexant hydrochloride is an orexin receptor antagonist approved by the FDA in January 2022 for the treatment of insomnia. It is marketed under the brand name Quviviq by Idorsia. The drug's market is positioned within the global sleep aid segment, historically dominated by benzodiazepines, Z-drugs, and newer antagonists like lemborexant. The demand for Daridorexant is driven by the increasing prevalence of insomnia, rising awareness about sleep health, and a shift toward non-benzodiazepine sleep therapies.

In 2022, the global sleep aids market was valued around $8.9 billion. It is projected to grow at a compound annual growth rate (CAGR) of 7-8% through 2028, influenced heavily by the aging population, lifestyle changes, and increased diagnosis of sleep disorders. Daridorexant aims to capture a share of this expanding market, competing primarily with lemborexant (Eli Lilly) and suvorexant (Belsomra, Merck).

How Does Daridorexant Fit Into the Competitive Landscape?

The key competitors include:

• Lemborexant (Eli Lilly): Approved since December 2019, marketed as Dayvigo. It holds a sizable market share due to early entry and proven efficacy. Lemborexant's global sales surpassed $300 million in 2022.

• Suvorexant (Merck): Launched in 2014, with a mature market presence, especially in the U.S. The drug generated sales approaching $650 million in 2022.

• Eszopiclone and Zolpidem: Older non-benzodiazepine drugs with high prescription volumes but declining due to safety concerns.

Idorsia's Daridorexant entered a crowded field with a differentiated profile emphasizing sleep maintenance and cognitive safety. Early clinical data indicate favorable tolerability, possibly giving it a competitive edge.

What Are the Financial Trajectories and Revenue Prospects?

1. Initial Launch and Revenue Projections:

   • In 2022, Idorsia reported initial revenues from Quviviq, with estimates ranging from $50 million to $100 million in the first year, depending on market uptake.

   • Analysts project Daridorexant to reach sales of $500 million by 2025, with potential to surpass $1 billion by 2028 if market penetration succeeds.

2. Pricing Strategy:

   • The average wholesale acquisition cost (AWAC) for Daridorexant aligns with other non-benzodiazepine sleep aids, approximately $4–$6 per dose.

   • Reimbursement will significantly influence sales growth, especially in the U.S., where Medicare and private insurers impact formulary placement.

3. Market Penetration Risks:

   • Competition from established drugs could limit early market share.

   • Physician familiarity and prescribing habits favor long-established therapies.

4. Regulatory and Developmental Factors:

   • Pending approvals in Europe and select Asian markets could expand revenue.

   • Ongoing post-marketing studies may bolster safety profiles and usage.

What Are the Market Entry Barriers and Regulatory Factors?

• FDA Approval and Labeling: Daridorexant benefits from regulatory clarity, with approved indications for insomnia. Labeling emphasizes longer duration of sleep and lower risk of next-day impairment.

• Pricing and Reimbursement: Price setting influences adoption. High prices relative to competitors may slow uptake unless justified by superior efficacy or safety.

• Market Saturation and Physician Adoption: Changing prescribing habits necessitate clinical education and proven differentiation.

• Patent and Exclusivity Timing: Idorsia's patent protections extend into the mid-2030s, providing a period of market exclusivity. Patent litigations and biosimilar threats are less relevant in small-molecule sleep drugs.

What Are the Long-Term Financial and Market Risks?

• Generic Competition: As patents expire, generic versions could erode margins and market share.

• Market Shifts: Development of novel therapies, including orexin antagonists with improved profiles or alternative mechanisms, could threaten Daridorexant’s market position.

• Regulatory Changes: Enhanced safety regulations or labeling restrictions could impact sales.

• Consumer Preferences: Preference for non-pharmacological interventions could reduce demand.

Key Takeaways

• Daridorexant is positioned in a growing sleep aid market expected to reach $15 billion globally by 2028.

• Early sales estimates range from $50 million to $100 million in 2022, with potential to exceed $1 billion by 2028.

• The drug’s competitive advantage depends on differentiation through safety and sleep maintenance efficacy.

• Market penetration will face barriers including established competitors, physician habits, and reimbursement policies.

• Patent protection offers a window until mid-2030s, but generic competition and new therapy development pose long-term risks.

FAQs

1. What is the primary therapeutic benefit of Daridorexant?
It improves sleep onset and maintenance in adults with insomnia, offering a favorable safety profile.

2. How does Daridorexant’s efficacy compare to existing treatments?
Clinical trials demonstrate non-inferior efficacy to existing orexin antagonists with potentially fewer next-day residual effects.

3. What are the key barriers to Daridorexant’s market growth?
Established competitors, physician prescribing habits, reimbursement policies, and eventual patent expiration.

4. How significant are potential markets outside the U.S.?
Markets in Europe, Japan, and Asia present growth opportunities, contingent on regulatory approval and market access strategies.

5. What is the outlook for Daridorexant’s long-term revenue?
Absent significant market disruptions, sales could reach $1 billion by 2028, driven by expanding indications and geographic expansion.

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References

1. MarketWatch. "Sleep Aids Market Size & Share Analysis." 2022.
2. Idorsia press releases. "FDA Approves Quviviq for Insomnia." January 2022.
3. EvaluatePharma. "2022 Sleep Disorder Drugs Sales Data."
4. Advisory Board. "Competitive Landscape of Sleep Aids." 2023.
5. FDA. "Drug Approvals" and label information for Daridorexant.