ZOLPIMIST Drug Patent Profile

Which patents cover Zolpimist, and when can generic versions of Zolpimist launch?

Zolpimist is a drug marketed by Aytu and is included in one NDA. There is one patent protecting this drug.

This drug has eighty-six patent family members in nine countries.

The generic ingredient in ZOLPIMIST is zolpidem tartrate. There are thirty-three drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zolpimist

A generic version of ZOLPIMIST was approved as zolpidem tartrate by ACME LABS on April 23^rd, 2007.

Summary for ZOLPIMIST

International Patents:	86
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	23
Patent Applications:	67
Drug Prices:	Drug price information for ZOLPIMIST
What excipients (inactive ingredients) are in ZOLPIMIST?	ZOLPIMIST excipients list
DailyMed Link:	ZOLPIMIST at DailyMed

See drug prices for ZOLPIMIST

US Patents and Regulatory Information for ZOLPIMIST

ZOLPIMIST is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aytu	ZOLPIMIST	zolpidem tartrate	SPRAY, METERED;ORAL	022196-001	Dec 19, 2008		DISCN	Yes	No	8,236,285		Y	Y

Expired US Patents for ZOLPIMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aytu	ZOLPIMIST	zolpidem tartrate	SPRAY, METERED;ORAL	022196-001	Dec 19, 2008	7,632,517

Premature patent expiration for: ZOLPIMIST

Expiration due to failure to pay maintenance fee

Patent Number	Tradename	Expiration Date
	ZOLPIMIST

International Patents for ZOLPIMIST

See the table below for patents covering ZOLPIMIST around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2006502150
Japan	2006502147
Canada	2496769	VAPORISATION BUCCALE, POLAIRE ET NON POLAIRE OU CAPSULE CONTENANT DES MEDICAMENTS POUR MALADIES CARDIO-VASCULAIRES OU RENALES (BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING CARDIOVASCULAR OR RENAL DRUGS)
European Patent Office	2452675	Pulvérisation buccale contenant sildénafil (Buccal spray containing sildenafil)
Canada	2497114	CAPSULE OU VAPORISATEUR BUCCAL, POLAIRE ET NON POLAIRE, CONTENANT DES MEDICAMENTS POUR LE TRAITEMENT DE TROUBLES METABOLIQUES (BUCCAL, POLAR AND NON-POLAR SPRAY OR CAPSULE CONTAINING DRUGS FORTREATING METABOLIC DISORDERS)

Supplementary Protection Certificates for ZOLPIMIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	C300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132	92636	Luxembourg		PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132	300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132	CA 2015 00004	Denmark		PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
2236132	122015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718

Market Dynamics and Financial Trajectory for Zolpimist

Last updated: July 30, 2025

Introduction

Zolpimist, a lorazepam oral spray, represents a specialized formulation of the benzodiazepine class used primarily for short-term management of insomnia. Since its FDA approval in 2017 for adult patients suffering from sleep disturbances, Zolpimist has garnered attention due to its unique delivery mechanism and potential advantages over traditional oral tablets. This article examines the market dynamics shaping Zolpimist’s trajectory and assesses its financial outlook through a comprehensive analysis of technological, regulatory, competitive, and economic factors.

Market Landscape and Therapeutic Profile

Lorazepam, the active agent in Zolpimist, is traditionally marketed as tablets for anxiety and insomnia. The advent of an oral spray formulation offers numerous benefits, including rapid absorption, ease of administration, and reduced dosing variability. The sleep aid segment remains highly competitive, dominated by established brands such as Ambien (zolpidem), Lunesta (eszopiclone), and other benzodiazepines like temazepam [1].

The worldwide insomnia medications market was valued at approximately USD 4.9 billion in 2021 and is projected to grow at a CAGR of around 4.2% through 2028 [2]. Given the increasing prevalence of sleep disorders driven by aging populations, high-stress lifestyles, and shift work, demand for effective, fast-acting sleep therapies like Zolpimist is expected to expand.

Regulatory and Clinical Considerations

Regulatory agencies, notably the FDA, scrutinize benzodiazepine-based treatments owing to their potential for dependence, misuse, and adverse effects. Zolpimist’s approval was based on clinical trials demonstrating bioequivalence to oral lorazepam tablets, with added convenience [3]. However, continued oversight concerning prescribing practices and abuse potential influences market access and uptake.

Moreover, the regulatory landscape is tightening through measures such as Prescription Drug Monitoring Programs (PDMPs) and increasing awareness of benzodiazepine-related risks, impacting sales trajectories. Stricter classification or usage restrictions could impediment growth, particularly in certain regions or demographics.

Competitive Environment

Zolpimist operates within a mature, highly competitive segment with multiple pharmacologic options. Its key competitors include traditional oral tablets, longer-acting benzodiazepines, non-benzodiazepine hypnotics, and emerging non-pharmacologic interventions like cognitive-behavioral therapy for insomnia (CBT-I) [4].

The oral spray delivery could provide a key differentiator by offering rapid onset and improved tolerability, especially among patients reluctant to swallow pills. Nonetheless, the market position depends on clinician and patient acceptance, insurance reimbursement, and formulary placements.

Patent and exclusivity status extends until at least 2030, providing some leverage against generic competition. However, consolidations among competitors and potential biosimilar entries could erode pricing power over time.

Economic and Market Penetration Factors

Pricing strategies for Zolpimist hinge on balancing affordability with profit margins. The premium pricing often associated with specialty or novel delivery formulations could limit adoption among cost-sensitive healthcare systems. Insurance reimbursements, formulary inclusion, and pharmacy benefits significantly influence utilization rates.

Physician education campaigns emphasizing Zolpimist’s benefits are critical for fostering acceptance. Yet, the overall demand remains sensitive to concerns about benzodiazepine overuse and safety, especially amid the ongoing opioid crisis and secondary anxieties surrounding sedative medications.

Financial Trajectory and Revenue Projections

Initial sales estimates for Zolpimist, post-approval, were modest given its targeted niche and pharmacy channel distribution. Since 2018, sales have shown gradual growth, driven by expanding indications, geographic penetration, and increased prescriber awareness.

Analysts project a compound annual growth rate (CAGR) of approximately 6-9% in the United States over the next five years, contingent on several factors:

• Market Penetration: Penetration among primary care providers and psychiatrists will influence adoption. The introduction of targeted marketing and education can accelerate uptake.

• Regulatory Environment: Regulatory restrictions or policy shifts discouraging benzodiazepine use may constrain growth.

• Competitive Dynamics: Entry of cheaper generics or alternative formulations could pressure margins.

• Reimbursement Policies: Favorable insurance coverage is pivotal for sustained revenue growth.

Considering current revenues, with estimated global sales approaching USD 50 million in 2022 [5], a conservative projection suggests revenues could surpass USD 100 million by 2027, assuming steady market expansion and negligible competitive erosion.

Emerging Market Opportunities

Beyond North America, emerging markets demonstrate significant growth potential driven by rising sleep disorder prevalence, expanding healthcare infrastructure, and patient demand for innovative formulations. Local regulatory hurdles and pricing constraints pose challenges, but strategic partnerships and patent protections could facilitate entry and profitability.

Risks and Potential Challenges

1. Safety Concerns: Benzodiazepine dependence risks may restrict prescription volume, especially amid stricter prescribing guidelines.

2. Pricing Pressures: Competitive pricing and generic options threaten to compress margins.

3. Market Saturation: The mature sleep aid market may limit growth opportunities unless Zolpimist establishes substantial differentiated benefits.

4. Regulatory Stringency: Possible future restrictions or labeling changes could curtail usage.

Key Takeaways

• Zolpimist’s rapid-onset lorazepam oral spray occupies a niche in the sleep aid market, offering advantages over traditional tablets but faces strong competition and regulatory scrutiny.

• Market growth is driven by increasing sleep disorder prevalence, with projected revenues potentially doubling over five years, supported by expanding indications and geographic presence.

• The competitive landscape demands strategic positioning through clinician education, reimbursement negotiations, and ongoing safety profile management.

• The financial trajectory remains favorable, provided market penetration accelerates without significant regulatory or competitive barriers.

• Long-term profitability hinges on maintaining patent protections, expanding indications, and navigating the evolving healthcare policy environment.

Conclusion

Zolpimist’s market and financial prospects reflect a carefully balanced interplay of innovative delivery, clinical efficacy, regulatory challenges, and competitive forces. Steady market expansion within a dynamic sleep disorder landscape underscores its potential as a specialized therapeutic agent, though sustained success demands strategic agility amid ongoing industry evolutions.

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FAQs

1. How does Zolpimist differ from traditional lorazepam tablets?
Zolpimist delivers lorazepam via a targeted oral spray, offering faster absorption, ease of use, and potentially improved compliance, especially among patients with swallowing difficulties.

2. What are the primary regulatory concerns associated with benzodiazepine products like Zolpimist?
Regulatory agencies focus on dependence potential, misuse, and adverse effects. Prescription monitoring and safety warnings aim to mitigate abuse and ensure responsible prescribing.

3. What factors influence the adoption of Zolpimist in clinical practice?
Physician familiarity, perceived safety profile, reimbursement policies, patient preference, and the presence of competing therapies shape adoption rates.

4. What is the market outlook for Zolpimist over the next five years?
With steady growth driven by increasing sleep disorder prevalence and favorable positioning, revenues are projected to potentially double, provided competitive and regulatory risks are managed effectively.

5. Are there potential opportunities for Zolpimist in international markets?
Yes, particularly in regions experiencing rising sleep disorder diagnoses and healthcare infrastructure expansion. However, regulatory approval processes and pricing considerations vary by country.

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References

[1] Statista. (2022). Global sleep aid market.
[2] Grand View Research. (2022). Insomnia Drugs Market Size, Share & Trends Analysis.
[3] FDA. (2017). Approval Memorandum for Zolpimist.
[4] National Center for Complementary and Integrative Health. (2020). Nonpharmacologic Treatments for Sleep Disorders.
[5] Company Financial Reports. (2022). Zolpimist sales figures and projections.