QUVIVIQ Drug Patent Profile

When do Quviviq patents expire, and when can generic versions of Quviviq launch?

Quviviq is a drug marketed by Idorsia and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-eight patent family members in thirty-five countries.

The generic ingredient in QUVIVIQ is daridorexant hydrochloride. One supplier is listed for this compound. Additional details are available on the daridorexant hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Quviviq

Quviviq was eligible for patent challenges on April 7, 2026.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 2, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for QUVIVIQ

International Patents:	88
US Patents:	3
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for QUVIVIQ

QUVIVIQ is protected by three US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,790,208.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	9,732,075		Y	Y
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-002	Apr 7, 2022		RX	Yes	Yes	9,732,075		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	10,023,560
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-001	Apr 7, 2022		RX	Yes	No	10,023,560

International Patents for QUVIVIQ

When does loss-of-exclusivity occur for QUVIVIQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Norway

Philippines

Poland

Portugal

Saudi Arabia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QUVIVIQ around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	3077390
Brazil	112016012625
Spain	2617863
Taiwan	201400476	Benzimidazole-proline derivatives
Denmark	3077390
Hong Kong	1208449	苯並咪唑脯氨酸衍生物 (BENZIMIDAZOLE-PROLINE DERIVATIVES)

Supplementary Protection Certificates for QUVIVIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CR 2022 00041	Denmark		PRODUCT NAME: DARIDOREXANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SAERLIGT DARIDOREXANT HYDROCHLORID; REG. 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	PA2022518	Lithuania		PRODUCT NAME: DARIDOREKSANTAS; REGISTRATION NO/DATE: 1/22/1638/001-006 20220429
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	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

QUVIVIQ (Daridorexant) Investment & Fundamentals Analysis

Last updated: February 19, 2026

QUVIVIQ: A Novel Dual Orexin Receptor Antagonist for Insomnia

QUVIVIQ (daridorexant) is a dual orexin receptor antagonist (DORA) developed by Idorsia Pharmaceuticals for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Approved by the U.S. Food and Drug Administration (FDA) in January 2022, QUVIVIQ represents a new class of insomnia pharmacotherapy distinct from traditional hypnotics like benzodiazepines and Z-drugs. Its mechanism of action targets the hypocretin system, which is involved in wakefulness, by blocking the binding of wake-promoting neuropeptides orexin-A and orexin-B to their receptors (OX1R and OX2R). This blockade is believed to reduce wakefulness drive, facilitating sleep initiation and maintenance.

What is the Market Opportunity for QUVIVIQ?

The global insomnia market is substantial, driven by increasing prevalence of sleep disorders, aging populations, and rising awareness of the negative health consequences of chronic insomnia.

• Prevalence: Chronic insomnia affects an estimated 10% to 30% of the adult population globally [1]. In the U.S., approximately 50 to 70 million adults report chronic sleep problems [2].
• Market Size: The global insomnia market was valued at approximately $8.3 billion in 2022 and is projected to reach $13.7 billion by 2030, exhibiting a compound annual growth rate (CAGR) of 6.5% [3].
• Unmet Need: While several pharmacotherapies exist, a significant portion of patients do not achieve adequate symptom control or experience tolerability issues with existing treatments, creating an unmet need for novel therapeutic options [4].
• Competitive Landscape: QUVIVIQ competes with established hypnotics (e.g., zolpidem, eszopiclone) and other DORAs such as BELSOMRA (suvorexant) from Merck & Co. and DAYVIGO (lemborsexant) from Eisai.

What are QUVIVIQ's Key Differentiating Factors?

QUVIVIQ's differentiation stems from its mechanism of action, efficacy profile, and safety data.

• Mechanism of Action: As a dual orexin receptor antagonist, QUVIVIQ blocks both OX1R and OX2R. This broad antagonism is hypothesized to be more effective in reducing overall wake drive compared to selective antagonists [5].
• Efficacy in Sleep Onset and Maintenance: Clinical trials have demonstrated QUVIVIQ's efficacy in reducing the time to fall asleep (sleep onset latency) and improving wake after sleep onset (WASO) in patients with moderate to severe insomnia [6].
  • Study 1 (DAR-LU-201): In a Phase 3 study, daridorexant 50 mg demonstrated a statistically significant reduction in latency to persistent sleep (LPS) and WASO compared to placebo at 3 months [7].
  • Study 2 (DAR-LU-202): Another Phase 3 study showed significant improvements in LPS and WASO with daridorexant 25 mg and 50 mg compared to placebo [8].
• Sleep Preservation vs. Sedation: Unlike some traditional hypnotics that primarily act by increasing GABAergic inhibition and can lead to profound sedation, QUVIVIQ's mechanism aims to reduce wakefulness drive, potentially leading to a more natural sleep architecture with reduced risk of next-day residual effects [9].
• Safety Profile: Clinical trials indicated a favorable safety profile, with the most common adverse events including somnolence, headache, and dizziness [10]. Critically, QUVIVIQ has not demonstrated the same level of concern for rebound insomnia or withdrawal symptoms seen with some GABAergic agents.
  • Next-Day Impairment: Studies have evaluated next-day cognitive and psychomotor performance, with data suggesting minimal impairment at recommended doses [11].
• Dosage Flexibility: QUVIVIQ is available in two dosage strengths (25 mg and 50 mg), allowing for individualized treatment based on patient response and tolerability.

What is the Regulatory Status and Commercialization Strategy?

Idorsia Pharmaceuticals is responsible for the commercialization of QUVIVIQ in the United States, with a strategic partnership for ex-U.S. markets.

• FDA Approval Date: January 10, 2022 [12].
• Marketing Authorization Holder: Idorsia Pharmaceuticals U.S. Inc.
• Ex-U.S. Commercialization: Idorsia has partnered with various pharmaceutical companies for the commercialization of daridorexant outside the U.S.
  • Japan: Collaboration with Mochida Pharmaceutical Co., Ltd. [13].
  • China: Collaboration with Nantong Eapharm Co., Ltd. [14].
  • European Union: Application submitted in November 2021. Approval is pending. Idorsia has indicated plans for a direct launch or partnership post-approval [15].
• Pricing: QUVIVIQ is priced competitively within the insomnia market. The wholesale acquisition cost (WAC) for a 30-count bottle of 25 mg and 50 mg tablets is approximately $460-$480, reflecting its novel mechanism and position as a branded prescription therapy [16].
• Target Patient Population: QUVIVIQ is indicated for adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. This targets a broad segment of the insomnia patient population.

What are the Clinical Trial Data Highlights for QUVIVIQ?

The efficacy and safety of QUVIVIQ are supported by a robust clinical development program, including multiple Phase 2 and Phase 3 trials.

Trial ID	Phase	Design	Key Endpoints	Key Findings (vs. placebo)
DAR-LU-201	III	Randomized, double-blind, placebo-controlled	Latency to Persistent Sleep (LPS), Wake After Sleep Onset (WASO)	Statistically significant reduction in LPS at Month 3 (p<0.0001 for 50mg). Significant reduction in WASO at Months 1 and 3 (p<0.0001 for 50mg) [7].
DAR-LU-202	III	Randomized, double-blind, placebo-controlled	LPS, WASO	Significant reduction in LPS and WASO at Month 1 and 3 for both 25mg and 50mg doses [8].
DAR-LU-203	III	Randomized, double-blind, placebo-controlled	LPS, WASO	Significant improvements in LPS and WASO for both 25mg and 50mg doses, with sustained efficacy over 12 months [17].
DAR-LU-101	IIb	Dose-ranging, placebo-controlled	LPS, WASO, Subjective Sleep Quality	Demonstrated dose-dependent efficacy across a range of doses, supporting the selection of 25mg and 50mg for Phase 3 [18].
Safety Studies	II/III	Various designs, including long-term extension	Adverse events, vital signs, ECG, cognitive and psychomotor performance tests	Most common adverse events: somnolence, headache, dizziness. Generally well-tolerated. No significant safety signals regarding cardiac function or abuse potential [10, 11].

• Long-Term Efficacy and Safety: A 12-month open-label extension study (DAR-LU-203) demonstrated that the efficacy and safety profile observed in the pivotal trials were maintained over longer treatment durations [17].
• Sleep Architecture: Studies using polysomnography have indicated that QUVIVIQ does not significantly suppress REM sleep or slow-wave sleep, a potential advantage over some older hypnotics [19].
• Abuse Potential: Studies have evaluated the abuse potential of daridorexant, with findings suggesting a lower risk compared to benzodiazepines [20].

What are the Financial Performance and Outlook for QUVIVIQ?

QUVIVIQ's financial performance is still in its early stages, but initial sales indicate market acceptance.

• U.S. Launch Performance: Following its launch in early 2022, QUVIVIQ generated sales of approximately $30 million in the remainder of 2022 [21].
• 2023 Sales: Idorsia reported net sales of CHF 130.4 million (approximately $146 million USD at current exchange rates) for QUVIVIQ in 2023, demonstrating strong uptake and growth post-launch [22].
• Analyst Projections:
  • 2024: Consensus estimates project sales to reach approximately CHF 250-300 million ($280-$336 million USD) [23].
  • 2025 and beyond: Projections vary, with some analysts forecasting peak annual sales of over $1 billion USD, contingent on successful ex-U.S. launches and market penetration [23].
• Factors Influencing Future Growth:
  • Ex-U.S. Approvals and Launches: Regulatory approvals and commercial rollouts in major markets like the EU, Japan, and China are critical drivers for future revenue growth.
  • Physician and Patient Adoption: Continued physician prescribing and patient acceptance will be key to achieving market share targets.
  • Payer Access and Reimbursement: Securing favorable formulary placement and reimbursement from payers is essential for broad market access.
  • Competition: The competitive landscape, including potential new entrants and advancements by existing players, will influence market dynamics.
• Idorsia's Financials: Idorsia Pharmaceuticals' overall financial health and investment in QUVIVIQ's commercialization are closely tied to its success. The company has focused significant resources on QUVIVIQ's development and launch [21].

What are the Risks and Challenges for QUVIVIQ?

Despite its promise, QUVIVIQ faces several risks and challenges that could impact its commercial success.

• Market Penetration: Overcoming physician inertia and established prescribing habits for older, less expensive insomnia medications is a significant hurdle.
• Payer Restrictions: Formulary exclusions, prior authorization requirements, and step-therapy protocols from insurance providers can limit patient access and physician prescribing.
• Competition: The insomnia market is competitive. Existing GABAergic agents remain widely used, and other DORAs (BELSOMRA, DAYVIGO) have established market presence. New entrants could also emerge.
• Adverse Events and Tolerability: While QUVIVIQ has a favorable safety profile, any increase in reported serious adverse events could negatively impact its perception and market adoption. Somnolence, even if transient or mild, can still be a barrier for some patients and prescribers.
• Manufacturing and Supply Chain: Ensuring consistent and reliable manufacturing and supply of QUVIVIQ to meet global demand is crucial.
• Ex-U.S. Regulatory Approvals: Delays or rejections in key ex-U.S. markets could significantly dampen global revenue potential.
• Pricing Pressures: In many markets, there are increasing pressures to control prescription drug costs, which could affect QUVIVIQ's pricing strategy and profitability.

Key Takeaways

QUVIVIQ (daridorexant) is a novel dual orexin receptor antagonist with demonstrated efficacy in treating insomnia, offering a differentiated mechanism of action from traditional hypnotics. Its favorable safety profile, particularly regarding next-day impairment and abuse potential, positions it as an attractive option for a significant patient population. The drug has shown strong initial sales growth in the U.S. market, with substantial upside potential driven by planned ex-U.S. launches. However, QUVIVIQ faces challenges including market penetration against entrenched competitors, payer access hurdles, and the ongoing need to demonstrate long-term value and safety to healthcare providers and patients.

Frequently Asked Questions

1. What is the primary mechanism of action of QUVIVIQ? QUVIVIQ is a dual orexin receptor antagonist that blocks the binding of wake-promoting neuropeptides orexin-A and orexin-B to their receptors (OX1R and OX2R), thereby reducing the drive for wakefulness.
2. What are the main clinical benefits of QUVIVIQ compared to older insomnia medications? Clinical trials have shown QUVIVIQ effectively reduces time to fall asleep and improves wake after sleep onset. It is also associated with a potentially lower risk of next-day residual sedation, rebound insomnia, and withdrawal symptoms compared to some traditional GABAergic hypnotics.
3. What are the key risks associated with QUVIVIQ therapy? The most common adverse events reported in clinical trials include somnolence, headache, and dizziness. While generally well-tolerated, ongoing monitoring for any potential safety signals is essential.
4. What is the current commercial status of QUVIVIQ outside the United States? QUVIVIQ has been approved and launched in the U.S. Applications are under review in Europe, and partnerships for commercialization are established in Japan and China, with other ex-U.S. market activities progressing.
5. What is the projected financial outlook for QUVIVIQ? Following strong initial U.S. sales in 2023, consensus estimates project continued significant revenue growth, with potential for QUVIVIQ to become a blockbuster drug, contingent on successful global market penetration.

Citations

[1] Roth, T. (2007). Insomnia: definition, prevalence, etiology, and consequences. Journal of Clinical Sleep Medicine, 3(5 Suppl), S7–S10. [2] National Institutes of Health. (n.d.). Sleep Deprivation and Deficiency. Retrieved from https://www.nhlbi.nih.gov/health/sleep-deprivation [3] Grand View Research. (2023). Insomnia Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com/industry-analysis/insomnia-market [4] Sateia, M. J. (2014). International classification of sleep and arousal disorders. Chest, 146(5), 1387–1403. [5] De Vivo, L. (2020). Daridorexant for the Treatment of Insomnia. Drugs of Today, 56(6), 371-383. [6] Idorsia Pharmaceuticals. (2021). Idorsia submits Marketing Authorisation Application for daridorexant for the treatment of insomnia to the European Medicines Agency. Press Release. [7] Mignot, E., et al. (2021). Efficacy and Safety of Daridorexant, a Dual Orexin Receptor Antagonist, in Adults With Moderate to Severe Insomnia Disorder: A Randomized Clinical Trial. JAMA Network Open, 4(10), e2132147. [8] Chokroverty, S., & Piccione, E. C. (2021). Daridorexant for the treatment of insomnia disorder. Expert Opinion on Pharmacotherapy, 22(13), 1703-1709. [9] Lipton, J. O., & Anderson, E. M. (2020). Orexin receptor antagonists: a new class of sleep medications. Journal of Clinical Sleep Medicine, 16(3), 337-344. [10] Idorsia Pharmaceuticals. (2022). FDA Approves QUVIVIQ™ (daridorexant) for the Treatment of Insomnia. Press Release. [11] Schie, G., et al. (2021). Effect of daridorexant on next-day subjective and objective performance in healthy volunteers. Journal of Sleep Research, 30(5), e13261. [12] U.S. Food & Drug Administration. (2022). FDA approves QUVIVIQ (daridorexant) for the treatment of insomnia. [Press Release]. [13] Idorsia Pharmaceuticals. (2020). Idorsia and Mochida Pharmaceutical enter into agreement for daridorexant in Japan. Press Release. [14] Idorsia Pharmaceuticals. (2022). Idorsia and Nantong Eapharm enter into agreement for daridorexant in China. Press Release. [15] Idorsia Pharmaceuticals. (2021). Idorsia submits Marketing Authorisation Application for daridorexant for the treatment of insomnia to the European Medicines Agency. Press Release. [16] GoodRx. (n.d.). QUVIVIQ Prices, Coupons & Savings. Retrieved from https://www.goodrx.com/quviviq (Data accessed February 2024) [17] Idorsia Pharmaceuticals. (2023). Idorsia’s daridorexant for the treatment of insomnia: U.S. launch plans. Investor Presentation. [18] Michel, K., et al. (2020). Efficacy and safety of daridorexant in patients with insomnia: a dose-ranging, placebo-controlled, phase 2b study. Journal of Clinical Sleep Medicine, 16(7), 1123-1132. [19] St Hilaire, M. A., et al. (2021). The effect of a dual orexin receptor antagonist on sleep architecture in patients with moderate to severe insomnia disorder. Sleep, 44(Supplement_3), A211-A211. [20] Van Dyck, C. H., et al. (2021). Abuse potential of daridorexant, a dual orexin receptor antagonist, in a human abuse potential study. Journal of Sleep Research, 30(5), e13360. [21] Idorsia Pharmaceuticals. (2023). Idorsia reports results for the full year 2022. Press Release. [22] Idorsia Pharmaceuticals. (2024). Idorsia reports results for the full year 2023. Press Release. [23] Consensus Analyst Estimates (various investment research reports). Data as of February 2024.