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-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
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	5,211,954
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991	5,326,758

International Patents for RESTORIL

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

Country	Patent Number	Title	Estimated Expiration
Germany	3731840
United Kingdom	8722205
Canada	1302886	COMPOSITION PHARMACEUTIQUE CONTENANT UN DERIVE DE LA BENZODIAZEPINE (PHARMACEUTICAL COMPOSITION CONTAINING A BENZODIAZEPIN DERIVATIVE)
Japan	S63101325	PHARMACOLOGICAL COMPOSITION CONTAINING BENZODIAZEPINE DERIVATIVE
France	2604091	NOUVELLES COMPOSITIONS PHARMACEUTIQUES A BASE D'UN DERIVE DE LA BENZODIAZEPINE
Italy	1221509	COMPOSIZIONE FARMACEUTICA CONTENENTE UN DERIVATO BENZODIAZEPINICO

RESTORIL Market Analysis and Financial Projection

Last updated: February 12, 2026

What Are the Market Dynamics for RESTORIL (Temazepam)?

Restoril (generic: temazepam) is a benzodiazepine primarily prescribed for short-term management of insomnia. The market for temazepam and similar hypnotics is influenced by regulatory changes, safety profiles, and competition from newer agents.

Regulatory Landscape and Prescribing Trends

Since its approval in the 1980s, temazepam has maintained a significant presence in insomnia treatment, especially among patients with contraindications to newer drugs. Recent regulatory scrutiny over benzodiazepine dependence and overdose risks has influenced prescription patterns.

The US Food and Drug Administration (FDA) issued warnings and label updates over the years emphasizing careful use. Many health systems encourage short-term prescriptions and monitor for abuse potential. This has limited long-term use and affected sales volume.

Competitive Dynamics

The benzodiazepine market faces competition from non-benzodiazepine sleep aids ("Z-drugs") such as zolpidem, eszopiclone, and zaleplon. These alternatives offer comparable efficacy with perceived lower dependence risks, though safety concerns persist.

Additionally, increasing interest in non-pharmacologic therapies (cognitive-behavioral therapy for insomnia, CBT-I) reduces reliance on medications like Restoril.

Key Drivers and Challenges

• Demand Drivers:

  • Short-term management of insomnia in specific patient populations.
  • Physician familiarity and established prescribing protocols.
  • Insurance coverage for older patients with chronic sleep disturbances.

• Challenges:

  • Dependence and withdrawal issues, leading to regulatory restrictions.
  • Stringent prescribing guidelines lowering prescription volume.
  • Shift towards non-benzodiazepine agents and behavioral therapies.

Market Size and Segmentation

Global sleep aids market was valued at approximately USD 6.6 billion in 2022, with benzodiazepines comprising roughly 30-40% of prescriptions, though declining. In the US, benzodiazepine prescriptions fell 20% from 2015 to 2020, reflecting regulatory and safety concerns.

Restoril's market share has declined correspondingly, with estimates suggesting a 10-15% share of benzodiazepine sleep aid prescriptions as of 2022.[1]

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What Is the Financial Trajectory of Restoril?

Historical Financial Performance

As a generic drug produced by multiple manufacturers, Restoril's sales volume reflects prescription patterns rather than brand-specific revenue. Major pharmaceutical companies hold generic manufacturing rights; revenue generation is primarily through licensing and distribution agreements.

In the U.S., retail sales for temazepam (brand and generic) were estimated at USD 150-200 million annually in the early 2010s. Since 2015, sales experienced a gradual decline, corresponding with broader benzodiazepine prescription reductions.

Pricing and Revenue Trends

The average wholesale price (AWP) for generic temazepam ranges from USD 0.15 to 0.30 per pill, with a treatment course totaling USD 3 to USD 10 depending on dosage. Market competition has driven generic prices down by approximately 20-30% over the past decade.

Major manufacturers, such as Teva Pharmaceuticals and Mylan, report stable sales volumes, but overall revenue for Restoril-related generics has plateaued or declined slightly due to prescription volume decreases.

Impact of Regulatory and Market Factors

Recent regulatory focus on dependence has led to more cautious prescribing, reducing sales volume. Additionally, the rise of non-benzodiazepine sleep aids and behavioral therapies further restrict market growth.

No recent significant patent activity exists; as a generic, Restoril's pricing is heavily influenced by market competition rather than patent protection. The absence of patent expiry or exclusivity schemes limits revenue expansion opportunities.

Future Financial Outlook

Given the ongoing decline in benzodiazepine prescriptions and shifting preferences, the financial trajectory for Restoril is expected to be flat or downward trending. No substantial indications suggest a market revival or new formulations. Industry analysts project a compound annual decline rate of 3-5% in the benzodiazepine sleep aid segment over the next five years.[2]

Revenue is constrained by these market dynamics. Manufacturers may focus on niche markets or repurpose formulations, but broad market expansion appears unlikely without significant shifts in prescription practices or regulatory environment.

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Key Takeaways

• The market for Restoril is declining as prescribers shift toward non-benzodiazepine agents and behavioral therapies.
• Regulatory concerns over dependence and abuse continue to limit long-term use and sales.
• Competitive pricing and market saturation hinder potential revenue growth, with generic sales plateauing or shrinking.
• The outlook suggests moderate contraction over the next five years unless new indications or formulations emerge.
• The global sleep aid market presents growth opportunities mainly through non-benzodiazepine therapies, with benzodiazepine sleep aids losing market share.

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Frequently Asked Questions

Q1: Can Restoril be reformulated for improved safety?
A1: While pharmaceutical reformulation is technically possible, there are no current indications of development in this area that would significantly alter its safety profile or market position.

Q2: Are there regulatory measures that could reverse the decline in benzodiazepine prescriptions?
A2: Regulatory measures are trending toward increased caution, not easing restrictions. Changes would more likely further limit prescribing.

Q3: How does the rise of non-drug therapies impact Restoril's market?
A3: Non-drug therapies like CBT-I reduce reliance on pharmacological treatments, directly decreasing demand for drugs like Restoril.

Q4: What are the primary markets for Restoril?
A4: The US remains the largest market due to high prescription volume, but its share is decreasing as prescribing patterns shift.

Q5: Is there any opportunity for generic manufacturers to increase sales?
A5: Limited, as prescription volume declines and market saturation occurs unless new uses or formulations are developed.

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References

[1] IQVIA; Global Sleep Aids Market Data 2022
[2] MarketWatch; Benzodiazepine Sleep Aids Market Forecast 2022-2027