RESTORIL Drug Patent Profile

Which patents cover Restoril, and what generic alternatives are available?

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-two 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

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

International Patents for RESTORIL

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

Country	Patent Number	Title	Estimated Expiration
Japan	S63101325	PHARMACOLOGICAL COMPOSITION CONTAINING BENZODIAZEPINE DERIVATIVE
Germany	3731840
United Kingdom	8722205
Switzerland	673947
France	2604091	NOUVELLES COMPOSITIONS PHARMACEUTIQUES A BASE D'UN DERIVE DE LA BENZODIAZEPINE
Belgium	1000318	NOUVELLES COMPOSITIONS PHARMACEUTIQUES A BASE D'UN DERIVE DE LA BENZODIAZEPINE.
United Kingdom	2195242

Investment Scenario and Fundamentals Analysis for Restoril (Temazepam)

Last updated: February 20, 2026

What is Restoril’s Market Position and Therapeutic Profile?

Restoril (generic: temazepam) is a benzodiazepine hypnotic used primarily for short-term treatment of insomnia. It was approved by the U.S. Food and Drug Administration (FDA) in 1981. Restoril’s patent expired in 2005, leading to widespread availability of generic formulations. Despite existing competition from other sleep aids, it retains Pharmamarkt interest due to its established efficacy and regulatory familiarity.

Market Overview and Trends

• Global Insomnia Drug Market: Valued at approximately $4.4 billion in 2021, expected to grow at a CAGR of 4-5% through 2027.[1]
• Generic Dominance: Generic sleep medications account for over 80% of prescriptions, pressuring brand-name sales.
• Regulatory Environment: Increasing scrutiny over benzodiazepines due to dependency concerns and regulatory restrictions on prescribing.

Revenue and Sales Data

Metric	2020	2021	2022 (Estimate)
U.S. Prescription Volume (units)	1.2 million	1.3 million	1.25 million
Estimated Sales (USD millions)	$50 million	$52 million	$48 million

Restoril accounts for a moderate share of benzodiazepine prescriptions, with declining sales noted in past years due to shifts toward newer sleep agents and non-benzodiazepine options.

Competitor Landscape

• Zolpidem (Ambien): Dominates short-term insomnia treatment with global sales exceeding $1 billion annually.
• Eszopiclone (Lunesta): Another popular non-benzodiazepine hypnotic with similar efficacy.
• Ramelteon (Rozerem): Melatonin receptor agonist with a favorable safety profile, but limited efficacy.

Restoril’s primary competition comes from these agents, alongside emerging drugs such as suvorexant.

Patent and Regulatory Status

• Patent Life: Expired in 2005; no active patents on the original molecule.
• Regulatory Outlook: No recent label updates or regulatory restrictions specific to Restoril. However, increased prescribing restrictions for benzodiazepines globally influence usage.

Therapeutic and Safety Profile Considerations

• Efficacy: Effective for short-term management of insomnia.
• Risks: Dependence, withdrawal, cognitive impairment, especially in older populations.
• Regulatory Actions: Some countries have restricted benzodiazepine prescriptions due to abuse potential.

Investment Risks and Opportunities

Risks

• Market Share Decline: Due to competition from newer agents and changing prescribing habits.
• Regulatory Constraints: Potential for tighter controls, limiting use and prescriptions.
• Safety Profile: Rising awareness of dependence risks may reduce demand.

Opportunities

• Niche Positioning: As a proven short-term sleep agent in specific populations.
• Formulation Innovation: Development of abuse-deterrent formulations or extended-release versions could revitalize interest.
• Private Labeling: Opportunities for third-party manufacturers given patent expiry.

Strategic Considerations

Investors should evaluate whether growth can derive from increased utilization within niche markets, or if regulatory shifts hinder future sales. Marketing efforts could focus on specific patient segments where benzodiazepines remain the preferred option under medical supervision.

Financial Outlook and Valuation

Due to patent expiration and market saturation, Restoril generates limited growth potential. Utility may be confined to niche markets or bundled with combination therapies targeting sleep disorders. With annual sales hovering around $50 million globally, substantial new revenue streams are unlikely without reformulation or combination products.

Investors should monitor legislative developments in major markets, including the U.S., EU, and Asia, and potential reformulation initiatives by generic manufacturers.

Key Takeaways

• Restoril faces limited growth prospects due to patent expiry and strong generic competition.
• The market for insomnia drugs is expanding but with increased regulatory and safety concerns around benzodiazepines.
• Niche applications and formulation innovations could offer incremental opportunities.
• Overall, traditional Restoril investment presents a conservative outlook with moderate revenue stability but limited high-growth potential.

Frequently Asked Questions

1. Can Restoril regain market share?
Only if reformulated or repositioned for specific niche markets, such as elderly patients or those requiring controlled-release formulations, which remains uncertain.

2. What regulatory hurdles exist for new formulations?
FDA approval would require demonstrating safety, efficacy, and abuse-deterrent properties, particularly given benzodiazepine regulations and abuse potential.

3. Are there ongoing patent protections or exclusivity?
No, initial patents expired in 2005. No recent exclusivity awards are in place.

4. What are primary safety concerns cited for Restoril?
Dependence, cognitive impairment, and sedation, especially in elderly populations.

5. How does Restoril compare with newer sleep medications?
It is less preferred due to safety profile concerns; newer agents like suvorexant or lemborexant have different mechanisms and potentially better safety profiles.

References

[1] Grand View Research. (2022). Insomnia Market Size, Share & Trends Analysis Report.