SUVOREXANT - Generic Drug Details

What are the generic sources for suvorexant and what is the scope of patent protection?

Suvorexant is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Suvorexant has seventy-five patent family members in thirty-six countries.

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for SUVOREXANT

International Patents:	75
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	72
What excipients (inactive ingredients) are in SUVOREXANT?	SUVOREXANT excipients list
DailyMed Link:	SUVOREXANT at DailyMed

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

Constraining patent/regulatory exclusivity:

11,980,623

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 SUVOREXANT

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

Sponsor	Phase
Ohio State University	PHASE2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	PHASE2
Merck Sharp & Dohme LLC	PHASE3

See all SUVOREXANT clinical trials

Generic filers with tentative approvals for SUVOREXANT

Applicant	Application No.	Strength	Dosage Form
		15MG	TABLET
		20MG	TABLET
		30MG	TABLET

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for SUVOREXANT

Drug Class	Orexin Receptor Antagonist
Mechanism of Action	Cytochrome P450 3A Inhibitors Orexin Receptor Antagonists P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SUVOREXANT

N05CJ	Orexin receptor antagonists
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

N05CM	Other hypnotics and sedatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for SUVOREXANT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELSOMRA	Tablets	suvorexant	5 mg, 10 mg, 15 mg and 20 mg	204569	1	2024-03-04

US Patents and Regulatory Information for SUVOREXANT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No	7,951,797		Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes	11,980,623		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes	10,098,892		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No	7,951,797		Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No	10,098,892		Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No	11,980,623		Y

International Patents for SUVOREXANT

Country	Patent Number	Title	Estimated Expiration
Honduras	2009001067
Canada	2670892
Russian Federation	2019126797	СОСТАВЫ ТВЕРДЫХ ДОЗИРОВАННЫХ ЛЕКАРСТВЕННЫХ ФОРМ АНТАГОНИСТА ОРЕКСИНОВОГО РЕЦЕПТОРА (COMPOSITIONS OF SOLID DOSAGE FORMS OF OREXIN RECEPTOR ANTAGONIST)
Argentina	088881
Denmark	2089382
South Korea	101299426

SUVOREXANT: Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What has driven SUVOREXANT’s market entry, adoption, and competitive positioning?

SUVOREXANT (branded in the US as Belsomra by Merck) is an orexin receptor antagonist indicated for insomnia. Its competitive set in major markets has largely been defined by benzodiazepine receptor agonists, benzodiazepines, and Z-drugs (with some overlap from sedating antidepressants and melatonin receptor agonists depending on country and formulary rules). The market story since launch has been shaped by three forces: (1) formulary access, (2) prescriber confidence and dosing convenience, and (3) label and safety profile relative to older sedatives.

Key market dynamics by dimension:

• Class differentiation vs legacy hypnotics

  • Orexin antagonism positioned SUVOREXANT as a non-benzodiazepine hypnotic approach.
  • Competitive substitution in practice has depended less on mechanism and more on coverage decisions and treatment-emergent adverse event profiles vs Z-drugs and benzodiazepines.

• Formulary and payer controls

  • Insomnia drug coverage is typically constrained by step therapy and/or prior authorization in managed care settings.
  • In these frameworks, SUVOREXANT’s penetration tends to track:
    1) insurer preference for non-controlled options,
    2) guideline alignment, and
    3) payer-specific “preferred” status within the hypnotic tier.

• Prescriber adoption curve

  • Hypnotics are sensitive to prescribing inertia: physicians often start with familiar products, then shift when evidence, safety messaging, and payer access align.
  • SUVOREXANT’s adoption has depended on whether it displaces Z-drugs for specific patient segments (sleep-maintenance vs sleep-onset patterns), and whether outcomes are sustained in real-world use.

Clinical label scope that anchors market use

• In the US, SUVOREXANT was developed for insomnia characterized by difficulties with sleep onset and/or maintenance, with dosing strategies intended to balance efficacy and next-day effects. This label structure influences how physicians segment patients and choose between hypnotics.

Competitive pressure

• The launch and subsequent years have faced ongoing competition from:
  • Z-drugs (e.g., zolpidem, eszopiclone, zaleplon),
  • benzodiazepines (depending on country),
  • and in some markets, dual orexin antagonists arriving after SUVOREXANT (notably later class entrants have shifted competitive dynamics).

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How does SUVOREXANT’s revenue trajectory connect to lifecycle events and patent/market exclusivity risk?

Lifecycle events in sleep medications typically drive revenue inflection through (1) new indications, (2) dose/label expansions, (3) safety communications, and (4) payer tightening in response to cost.

For SUVOREXANT, the dominant financial driver is time-to-generic exposure and exclusivity in each major market. The class economics are shaped by how quickly payers adopt generics after loss of protection and whether any “new” formulations or indications extend effective exclusivity.

What investors and strategists track

• Protection landscape by market: US and EU protection terms determine when generic entry can materially compress price.
• Real-world contracting: even before generic launch, payers may use price concessions to steer utilization toward preferred alternatives.
• At-risk period behavior: late-lifecycle sales often become less about incremental share gains and more about maintaining volume through formulary management and contracting.

Financial trajectory constraints

• A drug’s financial arc in insomnia categories is rarely linear because formulary status changes fast. Even without generic entry, revenue can flatten or decline if:
  • a payer removes non-preferred products,
  • a competitor out-contracts on net price,
  • or prescriber preference shifts due to safety perceptions or guideline updates.

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What does the demand pattern imply for net sales stability, pricing pressure, and volume?

In insomnia pharmacotherapy, demand is “elastic” to plan coverage and substitution. SUVOREXANT’s demand profile has reflected:

• Net price compression risk
  • Once formulary status is challenged or tier placement worsens, net price and persistence can decline without generic entry.
• Volume-driven versus price-driven revenue
  • For managed care, revenue often becomes volume dependent because plan switching reduces patient continuity across product lines.
• Dose utilization
  • Within-label dose selection affects realized sales because payer copays and prior authorization criteria are often dose-sensitive.

Implication for financial trajectory

• Late-cycle performance in insomnia is commonly a tug-of-war between:
  • market share maintenance among insured patients (volume resilience),
  • and incremental discounting to preserve preferred status (price erosion).

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How does SUVOREXANT’s competitive landscape affect long-term share and margin?

SUVOREXANT competes in a crowded, price-sensitive segment where margin pressure can rise even without generics due to contracting dynamics. The main competitive mechanics:

• Therapy substitution
  • Switching hypnotics is common when patients fail to sleep through a cycle or when adverse effects emerge.
• Guideline and risk messaging
  • Safety communications can shift prescribing away from specific subclasses. For SUVOREXANT, relative positioning depends on how its safety and tolerability compare in label-relevant endpoints.
• Class entry after SUVOREXANT
  • Later orexin antagonists and evolving prescriber preferences can compress share.

Business impact

• Higher competition typically leads to:
  • more aggressive rebates,
  • tighter access controls,
  • and faster share shifts when payer incentives change.

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What is the practical investor view of SUVOREXANT’s financial runway?

A credible financial runway assessment for SUVOREXANT is built from three layers:

1. Protection timetable

   • Determines the endpoint risk from generic entry and the slope of price erosion post-protection loss.

2. Managed care trajectory

   • Defines interim net sales resilience. Even with protection intact, formulary and step edits can reduce share.

3. Competitive response

   • Captures whether competitors gain net-price leverage or better payer outcomes, which can force Merck to respond with contracting.

Core conclusion

• SUVOREXANT’s financial trajectory has largely followed an expected insomnia lifecycle pattern: launch gains followed by maturity in a payer-controlled environment, with forward risk dominated by exclusivity expiry and generic substitution timing.

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Market and financial KPIs to monitor for SUVOREXANT

KPI	What it signals	Why it matters for SUVOREXANT
Formulary status (preferred vs non-preferred)	Access and persistence	Drives net sales more than class-level differentiation once mature
Net price trends (rebates/discounting)	Margin sustainability	Competitive tiers force pricing concessions before generics
Prescription share vs Z-drugs/benzodiazepines	Clinical adoption and switching	Indicates whether SUVOREXANT retains a “specific patient” footprint
Dosing persistence	Real-world continuation	Loss of persistence quickly reduces volume and raises churn risk
Generic launch timing (if applicable by market)	Structural price step-down	Determines the steepness of revenue compression

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Key Takeaways

• SUVOREXANT’s market dynamics are dominated by managed care access, formulary placement, and competitive contracting, not by mechanism alone.
• Its financial trajectory has followed the typical insomnia lifecycle: launch adoption, then maturity under payer controls, with exclusivity loss risk acting as the primary structural downside.
• The forward outlook is best modeled using a three-layer framework: protection timetable, payer trajectory, and competitive contracting behavior.

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FAQs

1) What drug class is SUVOREXANT in?
SUVOREXANT is an orexin receptor antagonist for insomnia.

2) What determines SUVOREXANT’s adoption versus older hypnotics?
Formulary access, payer rules, and prescriber confidence driven by outcomes and tolerability relative to Z-drugs and benzodiazepines.

3) Why do insomnia drugs show volatile revenue patterns?
Insomnia utilization is sensitive to tier placement, step therapy, prior authorization, and switching behavior across hypnotic options.

4) What is the main financial risk for SUVOREXANT over time?
The primary structural risk is loss of market protection and subsequent generic substitution in key jurisdictions.

5) Which KPI most directly predicts near-term net sales movement?
Changes in formulary status and net price (rebates/discounting) within managed care.

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References

[1] Merck. Belsomra (suvorexant) prescribing information. US FDA label.
[2] US FDA. Drug Approval Package for Belsomra (suvorexant). FDA.
[3] EMA. Suvorexant product information and assessment documents (where applicable). European Medicines Agency.