RESTORIL Drug Patent Profile

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

Restoril is a drug marketed by Specgx Llc and is included in one NDA.

The generic ingredient in RESTORIL is temazepam. There are seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the temazepam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Restoril

A generic version of RESTORIL was approved as temazepam by NOVEL LABS INC on April 21^st, 1987.

Summary for RESTORIL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	2
Patent Applications:	4,238
Drug Prices:	Drug price information for RESTORIL
What excipients (inactive ingredients) are in RESTORIL?	RESTORIL excipients list
DailyMed Link:	RESTORIL at DailyMed

See drug prices for RESTORIL

Recent Clinical Trials for RESTORIL

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

Sponsor	Phase
Massachusetts General Hospital	N/A
State University of New York - Upstate Medical University	Phase 2

See all RESTORIL clinical trials

Pharmacology for RESTORIL

Drug Class

Benzodiazepine

Paragraph IV (Patent) Challenges for RESTORIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RESTORIL	Capsules	temazepam	7.5 mg	018163	1	2006-11-01

US Patents and Regulatory Information for RESTORIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	AB	RX	Yes	No
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-004	Nov 2, 2004	AB	RX	Yes	No

Expired US Patents for RESTORIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	5,030,632
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	5,326,758
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	5,211,954

International Patents for RESTORIL

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

Country	Patent Number	Title	Estimated Expiration
Belgium	1000318	NOUVELLES COMPOSITIONS PHARMACEUTIQUES A BASE D'UN DERIVE DE LA BENZODIAZEPINE.
Italy	8748408
United Kingdom	2195242
France	2604091	NOUVELLES COMPOSITIONS PHARMACEUTIQUES A BASE D'UN DERIVE DE LA BENZODIAZEPINE

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: RESTORIL

Last updated: July 29, 2025

Introduction

Restoril (generic: temazepam) is a benzodiazepine primarily used for short-term management of insomnia. Approved by the FDA in 1981, it is marketed by several pharmaceutical companies, most notably Mallinckrodt Pharmaceuticals. As a sedative-hypnotic, Restoril has experienced fluctuating market dynamics influenced by regulatory, competition, and clinical factors. This analysis explicates its current market standing, future financial trajectory, and key factors shaping its commercial prospects.

Market Overview of Restoril

Restoril remains a notable treatment for insomnia, but its market share has waned in recent years due to evolving prescribing practices and rising concerns over benzodiazepine-related adverse effects. The global sleep aid market, valued at approximately USD 69 billion in 2021 and expected to grow at a CAGR of around 6%, presents opportunities and challenges for drugs like Restoril (1).

Despite the sunset of patent exclusivity in many markets, generic availability has driven down prices, impacting profitability. The drug's niche remains, especially among specific populations such as elderly patients with insomnia, but competition from newer classes like non-benzodiazepine sedatives (zolpidem, zopiclone) and melatonin receptor agonists (ramelteon) is intensifying.

Regulatory Landscape and Patent Dynamics

Although Restoril's patent expiry occurred decades ago, recent regulatory environments have influenced its market trajectory. Concerns over dependency, cognitive impairment, and falls in elderly populations have elevated scrutiny. The FDA has issued warnings regarding benzodiazepine use for insomnia, emphasizing short-term use and cautioning against long-term dependency risks (2). Consequently, prescriber shift toward newer agents has diminished Restoril’s prescribing volume.

Furthermore, there are no significant patent protections remaining, leading to increased generic competition. The absence of patent exclusivity constrains pricing power for manufacturers, pushing margins downward and limiting aggressive marketing efforts.

Competitive Landscape

Restoril competes against multiple pharmacologic agents:

• Non-benzodiazepine hypnotics: Zolpidem (Ambien, 2023 sales of ~$576 million in the U.S.), eszopiclone, and zaleplon offer similar efficacy with purported fewer side effects.
• Melatonin receptor agonists: Ramelteon provides an alternative, especially for elderly populations.
• Over-the-counter options: Melatonin supplements and lifestyle modifications are increasingly favored for mild insomnia.

This competitive environment results in declining prescriptions for Restoril, especially as clinicians prioritize agents with improved safety profiles and minimal dependency risks.

Market Trends and Influencing Factors

1. Shift Toward Non-Benzodiazepines and Non-Pharmacological Interventions

Clinicians are increasingly cautious with benzodiazepines; guidelines from agencies such as the American Academy of Sleep Medicine recommend limited use due to dependence potential. Cognitive Behavioral Therapy for Insomnia (CBT-I) is gaining prominence as a first-line treatment, reducing reliance on pharmacotherapy (3). This trend hampers growth prospects for drugs like Restoril.

2. Regulatory Pressures and Safety Concerns

Heightened regulatory scrutiny on benzodiazepines due to overdose risks, cognitive impairment, and falls among older adults constrains prescription rates. The opioid crisis has further amplified the focus on sedative safety, leading to more conservative prescribing patterns.

3. Aging Population and Insomnia Prevalence

Market opportunities persist owing to demographic shifts. The global elderly population is projected to reach nearly 1.5 billion by 2050, with insomnia prevalence rising with age (4). This demographic trend sustains demand for sleep aids. However, clinicians’ preference for safer agents limits potential growth of traditional benzodiazepines like Restoril.

4. Emerging Competitors and Market Fragmentation

Development of novel sleep therapeutics, including dual orexin receptor antagonists (suvorexant) and newer melatonin receptor agonists, fragment the sleep aid landscape. Companies investing in these areas could erode Restoril’s market share further.

Financial Trajectory Analysis

Historical Revenue and Profitability

While precise revenue data for Restoril are limited due to generic status and market fragmentation, historical projections estimate that the drug generated peak annual sales of approximately USD 150-200 million in the U.S. during the late 2000s (5). Currently, sales are suppressed owing to generic competition, with estimates falling below USD 50 million annually.

Forecast for the Next 5-10 Years

Given the current regulatory and competitive environment, Restoril's financial trajectory is likely to be characterized by:

• Continued decline in sales volume, driven by reduced prescriber preference.
• Pricing pressure owing to generic competition and payer negotiations.
• Potential stable niche sales among elderly populations with limited alternatives.

However, the absence of patent barriers, combined with the FDA’s cautions, suggests revenue erosion will persist. Unless a formulation reformulation or new indication is approved, growth prospects remain limited.

Potential for Market Stabilization or Revival

Revival avenues include:

• Reformulation: Developing a formulation with lower dependency risk may appeal amid regulatory pressures.
• Indication Expansion: Securing approval for additional indications, such as short-term anxiety or preoperative sedation, could broaden use.
• Strategic Partnerships: Licensing or co-marketing agreements with emerging sleep disorder solutions could reinforce sales.

Absent these initiatives, financial expectations point toward a gradual decline, with revenues plateauing at low but steady levels.

Regulatory and Market Risks

Risks include increased regulatory restrictions, further adverse effect disclosures, and evolving prescribing guidelines. Market risk is amplified by the dominance of newer, safer agents, and shifts toward non-pharmacologic therapies.

Key Drivers Shaping Restoril’s Market and Financial Outcomes

• Prescribing trends favoring non-benzodiazepines and behavioral therapies.
• Regulatory constraints emphasizing safety and limited long-term use.
• Generic competition suppressing prices and margins.
• Demographic trends underpinning persistent but constrained demand.
• Innovation in sleep therapeutics introducing more targeted options.

Conclusion

Restoril’s market dynamics are chiefly characterized by decline and stabilization within a shrinking niche. Its future financial trajectory hinges on demographic changes, regulatory developments, and therapeutic innovations. While the drug exhibits limited potential for substantial growth, niche markets, such as in elderly care, may sustain modest revenues. Companies holding or managing Restoril assets must navigate evolving safety concerns and competitive pressures, emphasizing strategic adaptation and potential formulation innovation.

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Key Takeaways

• Restoril’s revenue has declined due to patent expiry, generic competition, and shifts toward newer sleep agents.
• Regulatory concerns over benzodiazepines narrow its prescriptive use, particularly among vulnerable populations.
• Demographic shifts provide steady, albeit limited, demand owing to the aging population.
• Market competition from non-benzodiazepine agents and behavioral therapies constrains growth prospects.
• Strategic approaches, including formulation innovation or new indications, may stabilize revenues, though substantial growth is unlikely without significant pipeline developments.

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FAQs

1. Will Restoril regain market dominance in the future?
Unlikely. Market trends favor safety-focused agents, with regulatory and prescriber preferences continuing to decline Restoril’s prominence.

2. Are there newer formulations or patents in development for Restoril?
Currently, no significant reformulations or patent protections are announced, limiting prospects for revitalization through formulation changes.

3. How does regulatory scrutiny impact Restoril’s market?
Heightened safety and dependency concerns lead to prescriber caution, reducing prescriptions and sales.

4. What alternative therapies are most competitive against Restoril?
Non-benzodiazepine hypnotics like zolpidem, melatonin receptor agonists like ramelteon, and behavioral treatments such as CBT-I are leading alternatives.

5. Is there potential for Restoril in niche markets?
Yes. Its utility may persist among certain elderly or refractory patients, but growth opportunities are limited.

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References

1. Grand View Research. Sleep Aid Market Size, Share & Trends Analysis Report. 2021.
2. U.S. Food and Drug Administration. Safety update on benzodiazepine use. 2022.
3. Morin CM, et al. Cognitive Behavioral Therapy for Insomnia: An Evidence-Based Approach. Sleep. 2016;39(12):1933-1938.
4. Klymko N, et al. Insomnia in Older Adults. Clin Geriatr Med. 2018;34(4):607-623.
5. Morningstar. Pharmaceutical Market Data, 2022.