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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	1
Patent Applications:	24
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
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
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
Australia	2014358743
Brazil	112016012625
Canada	2929720
Chile	2016001348
China	105793258
Cyprus	1119687

Supplementary Protection Certificates for QUVIVIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2855453	PA2022518	Lithuania		PRODUCT NAME: DARIDOREKSANTAS; REGISTRATION NO/DATE: 1/22/1638/001-006 20220429
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	122022000059	Germany		PRODUCT NAME: DARIDOREXANT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, INSBESONDERE DARIDOREXANT-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1638 20220429
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	CA 2022 00041	Denmark		PRODUCT NAME: DARIDOREXANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SAERLIGT DARIDOREXANT HYDROCHLORID; REG. NO/DATE: EU/1/22/1638 20220502

Last updated: June 13, 2026

QUVIVIQ (daridorexant) market dynamics and financial trajectory: exclusivity, pricing, uptake, and risk to revenue

Executive summary: QUVIVIQ (daridorexant) launched in the U.S. in 2022 as an oral orexin receptor antagonist (ORA) for insomnia. Market dynamics are shaped by (1) dual-orexin competition (AHTR: lemborexant, DORA: daridorexant), (2) payer controls and step-edit restrictions, (3) safety-driven positioning versus sedative-hypnotics, and (4) the size and growth of the insomnia drug category. Daridorexant’s financial trajectory is tied to how quickly it expands within formularies and secures guideline-consistent prescribing, while retaining advantage after label-driven competitors intensify promotional coverage and price pressure through contracting.

---

What is QUVIVIQ (daridorexant) and where does it sit in the insomnia drug market?

QUVIVIQ is an oral orexin receptor antagonist for insomnia. It competes in the broad insomnia therapeutics landscape that includes:

• Orexin receptor antagonists: daridorexant (QUVIVIQ), lemborexant (Dayvigo)
• Benzodiazepine receptor agonists (Z-drugs and analogs): zolpidem, eszopiclone, zaleplon, etc.
• Melatonin receptor agonists: ramelteon
• Tricyclics and other agents used off-label or historically

Market positioning drivers

• Class novelty and tolerability narrative relative to older sedative-hypnotics: orexin antagonism is differentiated from GABAergic sedation, which can support formulary acceptance even when acquisition cost is higher.
• Efficacy and dosing convenience support initial adoption, but long-term share depends on payer restrictions and real-world adherence.
• Wake-time function and next-day impairment claims influence formulary committees and clinician switching from Z-drugs when plan policies allow.

---

How do orexin receptor antagonists change market dynamics versus Z-drugs in insomnia?

Orexin receptor antagonists create a “premium” segment inside a crowded insomnia category.

Key market dynamics

1. Switching behavior
   Patients and prescribers that previously started on Z-drugs may shift to orexin antagonists when plans remove restrictions or when safety concerns drive substitution.

2. Formulary tiering and utilization management
   Payers commonly seek step therapy, preferred-agent contracting, or quantity edits for expensive CNS drugs. Orexin antagonists tend to face tighter restrictions than generics but can still win share if they reduce perceived risk.

3. Copay and channel management
   Manufacturer assistance programs and contracting can change net price and adherence. These effects matter for financial trajectory even when list price is stable.

4. Proliferation of competing ORAs
   The market is no longer “first-in-class pricing.” Competitor contracting can compress net pricing and increase marketing intensity.

---

What patents and exclusivity timelines protect QUVIVIQ’s US revenue stream?

Daridorexant protection and exclusivity determine how long QUVIVIQ can sustain branded revenue without generic ORA competition. Patent life impacts licensing leverage, settlement posture, and payer negotiation strategy.

Brand protection sources

• Drug substance and composition-of-matter patents for daridorexant (assignee varies by patent family).
• Formulation and method-of-use patents (dose regimens, pediatric extensions if applicable, and specific insomnia indications).
• Regulatory exclusivities under the Hatch-Waxman framework (5-year new chemical entity exclusivity plus additional exclusivities if triggered by regulatory pathway and litigation outcomes).

Actionable revenue implication

• If patent and regulatory exclusivity remain intact through the forecast horizon, revenue is mainly exposed to share loss from lemborexant and other insomnia products, not to direct generic substitution.
• If any late-expiring formulation or method-of-use patents narrow coverage, it can accelerate competitive switching to “authorized” alternatives or reduce marketing differentiation.

(Note: No patent or exclusivity dataset was provided in the request payload, and this response does not include verifiable expiration dates or specific Orange Book listings.)

---

What is the competitive landscape for QUVIVIQ versus Dayvigo (lemborexant)?

Both QUVIVIQ and Dayvigo are orexin receptor antagonists and are frequently compared by prescribers and payers as a therapeutic alternative set.

Competition levers

• Net price and formulary placement: preferred status drives volume.
• Dosing strategy: efficacy at sleep onset and sleep maintenance profiles shape which clinicians choose which agent.
• Safety perceptions: early real-world pharmacovigilance narratives and label interpretation affect switch rates.
• Contracting: channel rebates and payer rebates decide “effective price” and short-term growth.

Market outcomes

• When one ORA is designated preferred by a payer, the other faces resistance. Share often shifts toward the preferred product within a class rather than expanding the class total.
• The market can still grow overall if ORAs expand the treatable population versus undertreated insomnia.

---

How does QUVIVIQ uptake typically progress after launch: prescriber adoption versus formulary approvals?

For CNS insomnia drugs, commercial uptake follows a pattern driven by payers and clinicians.

Adoption phases (common pattern)

1. Early formulary entry
   Uptake is constrained to plans that accept the drug without restrictive criteria.
2. Utilization management tuning
   Step edits and prior authorization tighten or loosen depending on outcomes and competitive pressure.
3. Clinic switching and guideline alignment
   Continued growth depends on sustained prescribing by primary care, sleep medicine, and psychiatry, often driven by real-world effectiveness and tolerability.
4. Competitive displacement
   Competing ORAs can trigger switching back, especially when payer contracts change.

Financial implication

• Initial revenue traction can be meaningful even with limited formularies, but long-term trajectory depends on national formulary coverage and specialty pharmacy channel execution.

---

What pricing and reimbursement dynamics drive QUVIVIQ net sales?

Financial trajectory is most sensitive to net price, not list price.

Net pricing drivers

• Rebates and contracting with PBMs and managed care organizations.
• Patient assistance that reduces effective copay and supports persistence.
• Plan exclusions that cap share in restricted populations.
• Class competitive pricing as Dayvigo and other therapies gain preferred status.

How this impacts earnings

• Rebates can rise when competition intensifies, compressing gross-to-net.
• Increased marketing spend to defend share can lift selling expenses during share consolidation.

---

How does QUVIVIQ growth affect the broader insomnia category revenue?

Orexin antagonists typically grow the category by:

• pulling patients from Z-drugs where safety concerns or next-day impairment dominate,
• converting undertreated insomnia into treated insomnia where prescribers need options outside older sedatives,
• enabling payers to manage risk rather than only manage cost.

But category growth is not automatic

• If payers impose step therapy, orexin agents may cannibalize Z-drugs without expanding total treated volume.
• Preference swaps between ORAs can raise category spend while redistributing share.

---

When does QUVIVIQ face generic entry risk, and what Paragraph IV litigation scenarios could change the timeline?

Generic entry risk is driven by:

• the first date when patents or exclusivity are no longer enforceable,
• any Paragraph IV certifications challenging Orange Book-listed patents,
• any settlement agreements that delay entry.

Financial impact

• A successful challenge or a settlement that accelerates entry can produce a material revenue shock.
• Even without generic approval, uncertainty can affect payer negotiating leverage and manufacturer forecasting.

(No Orange Book listing, litigation docket, or settlement dates were included in the request. This response therefore does not provide specific Paragraph IV case numbers or entry calendars.)

---

What regulatory and FDA pathway factors shape QUVIVIQ adoption and label-driven demand?

Key demand-shaping factors include:

• initial FDA approval indication and any label expansions,
• dosing guidance and safety warnings that influence prescribing decisions,
• REMS requirements if any (none are provided in the request),
• post-marketing label interpretation by clinicians.

Regulatory-driven commercial effect

• Label clarity reduces prescriber hesitation and can speed adoption.
• Safety warnings can slow switching from older agents if perceived risk is higher than expected.

---

What formulations and dosing are commercially relevant for QUVIVIQ’s revenue profile?

For a marketed insomnia drug, revenue typically reflects:

• covered strengths and the dosing schedule,
• payer coverage for different dose ranges,
• how quickly clinicians titrate toward the most reimbursed dose.

Financial implications

• If a payer covers only certain strengths with lower copay or fewer edits, net sales can tilt toward those strengths.
• If dosing requires higher utilization management at specific strengths, growth slows even when clinical efficacy exists.

(No product-specific dosing economics were included in the request; this response does not enumerate strength-by-strength net price or utilization.)

---

How strong is QUVIVIQ’s patent estate versus generic and authorized generic entry risk?

Patent strength matters for:

• time to generic launch,
• litigation likelihood and expected cost,
• settlement leverage with challengers.

Commercial translation

• Strong estates can support stable net sales by discouraging early challenges.
• Weak or narrow patents can accelerate “design-around” formulations or method-of-use strategies and increase competitive pricing pressure even before generics arrive.

(Specific patent counts, jurisdictions, claims, and expiration dates were not provided in the request payload and are not listed here.)

---

What is the litigation landscape that could change QUVIVIQ’s financial trajectory?

Litigation can change the forecast through:

• trial outcomes that clarify enforceable scope,
• injunctions that delay launch,
• settlements that impose shared market restrictions.

Financial scenarios

• Pro-manufacturer outcomes sustain revenue longer and support higher payer confidence.
• Adverse rulings can cause rapid share loss and price compression.

(No specific litigation docket details were provided in the request payload.)

---

Which geographies are most likely to drive QUVIVIQ revenue, and how does global patent coverage influence this?

Market risk differs by region based on:

• local patent term adjustments,
• local regulatory exclusivity length,
• PBM structures and reimbursement norms.

Commercial pattern

• U.S. typically sets most strategic pricing and sales trajectory for new CNS brands.
• EU and other markets can contribute meaningful incremental revenue but are often exposed to earlier pricing pressure.

(No territory-level sales or regulatory data were provided in the request.)

---

Key Takeaways

• QUVIVIQ’s market trajectory is primarily shaped by orexin class competition (daridorexant versus lemborexant) and payer utilization management, which determine net price and formulary access.
• Revenue sustainability depends on maintaining preferred contracting and minimizing share loss to the competing ORA rather than on generic threat in the immediate term, assuming intact exclusivity and enforceable patent coverage.
• Financial sensitivity is highest to gross-to-net dynamics (rebates, assistance, contracting) and to any exclusivity or patent events that could accelerate competitive entry.
• Litigation and Orange Book-driven entry calendars are decisive for downside risk, but no listing or docket inputs were included in the request, so no event dates are stated here.

---

FAQs

1. How do PBM step edits and prior authorization typically affect orexin receptor antagonist prescribing for insomnia?
2. Do orexin antagonists mostly cannibalize Z-drugs, or do they expand the number of patients treated for insomnia?
3. How does net price compression usually evolve when a second ORA gains preferred formulary status?
4. What commercial signals indicate increased generic-entry risk for a CNS branded product?
5. Which payer segments most influence early growth for insomnia brands after FDA launch?

---

References (APA)

1. No cited sources were provided in the request and no external sources are included in this response.

DrugChatter Q&A for QUVIVIQ

Quviviq fda approval date?
How much is quviviq without insurance?
Quviviq cost without insurance?
Does quviviq have a generic?
Why is quviviq so expensive?