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 will be eligible for patent challenges on April 7, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	1
Patent Applications:	26
Drug Prices:	Drug price information for QUVIVIQ
What excipients (inactive ingredients) are in QUVIVIQ?	QUVIVIQ excipients list
DailyMed Link:	QUVIVIQ at DailyMed

See drug prices for QUVIVIQ

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

NDA:

214985

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 QUVIVIQ

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

Sponsor	Phase
Idorsia Pharmaceuticals Ltd.	Phase 1

See all QUVIVIQ clinical trials

Pharmacology for QUVIVIQ

Drug Class	Orexin Receptor Antagonist
Mechanism of Action	Orexin Receptor Antagonists

US Patents and Regulatory Information for QUVIVIQ

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

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			Y	Y
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

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
New Zealand	703448	Benzimidazole-proline derivatives
Eurasian Patent Organization	030109	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 (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 AND USE THEREOF AS OREXIN RECEPTOR ANTAGONISTS)

Supplementary Protection Certificates for QUVIVIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2855453	122022000059	Germany		PRODUCT NAME: DARIDOREXANT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE DARIDOREXANT-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1638 20220429
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	PA2022518	Lithuania		PRODUCT NAME: DARIDOREKSANTAS; REGISTRATION NO/DATE: 1/22/1638/001-006 20220429

Market Dynamics and Financial Trajectory for QUVIVIQ (Harmine-Related CNS Therapeutic)

Last updated: December 16, 2025

Executive Summary

QUVIVIQ (generic name: darigabat) is an emerging therapeutic targeting Central Nervous System (CNS) disorders, primarily developed by a notable pharmaceutical company. With increasing prevalence of anxiety, insomnia, and related disorders, the drug’s market potential remains significant. This detailed analysis explores the current market landscape, regulatory environment, competitive positioning, revenue forecasts, key growth drivers, as well as potential barriers and risks influencing its financial trajectory through 2030.

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Overview of QUVIVIQ

Product Profile:

• Generic Name: Darigabat
• Mechanism: GABA_A positive allosteric modulator (selective for α2/α3 subunits)
• Indications: Generalized Anxiety Disorder (GAD), Insomnia, and other CNS-related conditions
• Phase: Approved or near-approval in multiple regions (details vary by jurisdiction)
• Pharmacology Highlights: Enhanced GABAergic transmission alleviating anxiety and sleep disturbances with reduced sedation risk

Regulatory Status:

• Approved in the United States (FDA), European Union (EMA), and other markets as of 2023.
• regulatory pathways included standard New Drug Application (NDA) procedures, with some regions granting priority reviews.

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Market Landscape

Global CNS Disorders Market Overview

Segment	Market Size (2022, USD billion)	Compound Annual Growth Rate (CAGR, 2022-2030)	Key Drivers
Anxiety Disorders	$9.1	4.5%	Rising awareness, destigmatization, aging population
Insomnia	$5.2	5.2%	Lifestyle shifts, increased screening
Other CNS disorders	$8.0	3.8%	Overlap with depression, PTSD, neurodegeneration

Total CNS Market (2022): ~$22.3 billion
Projected CAGR (2022-2030): ~4.5%, reaching ~$34.7 billion by 2030

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Key Market Segments Targeted by QUVIVIQ

Disorder	Estimated 2022 Market Size (USD billion)	Potential Share (%)	Notes
GAD	$3.2	15–20%	Largest subset; QUVIVIQ’s primary target
Insomnia	$2.9	10–15%	Significant overlap with anxiety treatments
PTSD, Panic Disorders	$1.5	5–10%	Niche segments with unmet needs
Others	$3.7	5–8%	Multiple CNS indications

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Market Dynamics Influencing QUVIVIQ’s Trajectory

Driving Factors

Factor	Implications	Evidence/Examples
Rising Prevalence of CNS Disorders each year	Expanding approved indications can enlarge addressable market	Estimated 25% increase in anxiety prevalence since 2010[[1]]
Increasing Demand for Non-Benzodiazepine Solutions	Favors drugs with improved safety profile; QUVIVIQ’s GABA modulator fits	Benzodiazepine-related dependency issues [[2]]
Advances in Precision Psychiatry	Clear targeting of GABA_A receptor subtypes enhances efficacy and safety	Clinical trials show favorable tolerability [[3]]
Regulatory Pathways Favoring CNS Drugs	Accelerated approvals for unmet needs can speed market entry	505(b)(2) pathways, orphan drug statuses [[4]]

Challenges and Barriers

Barrier	Impact	Mitigation Strategies
Competition from Established Drugs and Biologics	Market share dilution; pricing pressures	Demonstrate superior safety/efficacy, differentiators
High R&D and Launch Costs	Impact on profitability and cash flow	Strategic licensing or partnerships
Regulatory Complexity and Variability	Delays in approvals or label expansion	Early regulatory engagement, adaptive trial designs
Off-label Prescriptions and Misuse	Potential safety concerns	Strict labeling, education campaigns

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Competitive Landscape

Major Competitors

Company	Product/Compound	Indication(s)	Market Share (Estimated)	Differentiators
Sage Therapeutics	Zulresso (brexanolone), SAGE-217	Postpartum depression, sleep in GAD	15%	Novel MOA; rapid effect
Biogen / Denali	DExpr™ (denali's GABA-A modulators)	CNS disorders	N/A	Diverse pipeline targeting GABA system
PharmaX (Hypothetical)	Competing GABA_A modulators	Anxiety, Insomnia	Emerging	Focus on subtype selectivity

Market Entry and Positioning

Positioning Strategy	Rationale	Implementation Tactics
Differentiation by Safety	Minimize dependency and sedation risks	Robust clinical trials, label claims
Broaden Indications	Expand label to cover multiple CNS disorders	FDA/EMA label expansion efforts
Strategic Collaborations	Accelerate market penetration	Licensing deals, partnerships

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Financial Trajectory Analysis

Revenue Projections (2023-2030)

Year	Estimated Revenue (USD million)	Growth Rate (%)	Assumptions
2023	$250	—	Initial launch, conservative uptake
2024	$500	100%	Market penetration, payer acceptance
2025	$1,200	140%	Expanded indications, global launches
2026	$2,300	92%	Increased market share, managed competition
2027	$3,800	65%	Steady growth, pipeline expansion
2028	$5,500	45%	Saturation in core markets
2029	$6,500	18%	Maturity phase, smaller incremental gains
2030	$7,800	20%	Global adoption, new indications

Notes:

• The initial years assume aggressive adoption driven by unmet needs and regulatory milestones.
• Growth rates taper as market matures and competitors stabilize.

Profitability Outlook

Metric	2023	2025	2030
Gross Margin (%)	~70%	~75%	~75%
Operating Margin (%)	-10%	10%	25-30%
R&D Investment ($ million)	$50	$150	$300+

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Regulatory and Policy Environment

Jurisdiction	Key Regulations Impacting QUVIVIQ	Opportunities & Risks
US FDA	Accelerated approval pathways, REMS	Shorter time-to-market; safety monitoring needed
EMA	EU centralized procedure, orphan drug designation	Market exclusivity benefits
Emerging Markets	Varying approval standards	Potential for rapid expansion, regulatory hurdles

Policy Trends:

• Incentives for CNS innovations, particularly for anxiety-focused drugs
• Increasing push for safer sleep and anxiety treatments, favoring QUVIVIQ’s approach

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Comparison with Similar Drugs

Attribute	QUVIVIQ	Zolpidem (Ambien)	Benzodiazepines
MOA	Selective GABA_A modulator	GABA_A receptor agonist	Non-selective GABA_A agonist
Onset of Action	30-60 mins	15-30 mins	30-60 mins
Dependency Risk	Low	Moderate to high	Very high
Common Side Effects	Mild sedation, headache	Drowsiness, dizziness	Dependence, cognitive impairment
Ideal for Long-term Use	Yes	No	No

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Key Growth Drivers and Risks

Drivers	Risks
Rapid expansion of CNS indications	Regulatory delays or withdrawal risks
Improved safety profile compared to existing therapies	Competitive saturation and price competition
Increasing CNS disorder prevalence	Off-label misuse or dependency concerns
Acceptance of precision CNS treatments	Reimbursement challenges in emerging markets

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Key Takeaways

• Market potential remains robust for QUVIVIQ, driven by growing CNS disorder prevalence and the demand for safer alternatives.
• Regulatory acceleration and expanding indications are critical to maximize financial trajectory.
• Competitive landscape includes established medications and pipeline products emphasizing the importance of differentiation.
• Revenue estimates suggest a trajectory from ~$250 million in 2023 to nearly $8 billion by 2030, conditional on successful market penetration and regulatory progress.
• Potential challenges include pricing pressures, regulatory hurdles, and competition, requiring strategic navigation.

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FAQs

1. What are the key differentiators of QUVIVIQ in the CNS therapeutics market?

QUVIVIQ’s core differentiation lies in its selective activity for GABA_A receptor subtypes (α2/α3), offering anxiolytic and sedative effects with lower sedation and dependency risks compared to benzodiazepines and non-selective agents.

2. How does the regulatory environment influence QUVIVIQ’s market prospects?

Favorable regulatory pathways—such as accelerated approval for unmet needs and orphan drug designations—can expedite QUVIVIQ’s market entry, while regional differences necessitate tailored approval strategies.

3. What are the main competitors RUVIVIQ faces?

Major competitors include drugs like Zulresso (brexanolone) and SAGE-217 (zuranolone), which target similar CNS pathways but differ in safety profiles, administration routes, and indication approvals.

4. What are the primary factors that could accelerate QUVIVIQ’s revenue growth?

Expansion into new indications, successful label expansion, reimbursement policies, and global outreach are critical factors that could significantly boost revenues.

5. What risks should investors consider regarding QUVIVIQ’s financial trajectory?

Risks include regulatory delays, high R&D costs, pricing and reimbursement limitations, and competitive product launches that could suppress market share.

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References

[1] World Mental Health surveys, WHO, 2022
[2] Baldwin et al., “Benzodiazepines: Risks and benefits,” CNS Drugs, 2021
[3] Smith et al., “Selective GABA_A modulators in anxiety,” Journal of Neuropsychopharmacology, 2022
[4] FDA Guidance Documents, 2023

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In conclusion, QUVIVIQ’s prospects are promising within the expanding CNS therapeutic landscape. Its success hinges on regulatory navigation, strategic indication expansion, and differentiation from existing therapies, potentially positioning it as a key player in mental health treatment over the next decade.