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-seven 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:	34
Clinical Trials:	2
Patent Applications:	4,094
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
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-003	Oct 25, 1991

International Patents for RESTORIL

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

Country	Patent Number	Title	Estimated Expiration
Germany	3731840
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
Italy	1221509	COMPOSIZIONE FARMACEUTICA CONTENENTE UN DERIVATO BENZODIAZEPINICO

RESTORIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Restoril (Temazepam)

Market Overview

The benzodiazepine drugs market, which includes Restoril (temazepam), is experiencing significant growth driven by several key factors.

Increasing Prevalence of Mental Health Disorders

The rising incidence of anxiety disorders and insomnia worldwide is a primary driver for the benzodiazepine drugs market. According to the National Institute of Mental Health (NIMH), an estimated 31.1% of U.S. adults experience some form of anxiety disorder at some time in their lives, increasing the demand for effective treatments like Restoril[1].

Growing Acceptance of Pharmacological Interventions

The growing acceptance and awareness of pharmacological interventions for mental health conditions also contribute to the market growth. This shift in societal attitudes towards mental health treatment has led to an increased prescription rate for benzodiazepines, including Restoril.

Market Size and Growth Projections

Current Market Size

The benzodiazepine drugs market, which includes Restoril, was valued at USD 2.8 billion in 2023[1].

Growth Projections

The market is expected to reach USD 4 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 3.9% over the forecast period from 2024 to 2032[1].

Segmentation and Market Share

Drug Class

Restoril falls under the short-acting benzodiazepine category. The short-acting segment held a dominant market share of 55.3% in 2023, indicating strong demand for drugs like Restoril[1].

Indication

Restoril is primarily indicated for the short-term treatment of insomnia. The anxiety segment, which also includes insomnia treatments, is expected to reach USD 1.45 billion by 2032, further solidifying Restoril's market position[1].

Route of Administration

The oral route of administration, which is how Restoril is typically administered, held the highest market share in 2023 and is anticipated to grow at a CAGR of 3.7% between 2024 and 2032[1].

Distribution Channel

The hospital pharmacy segment, a key distribution channel for Restoril, is expected to be valued at USD 2.1 billion by 2032, highlighting the significant role of healthcare institutions in the drug's distribution[1].

Regional Market Performance

North America

North America held a market share of 41.8% in the global benzodiazepine drugs market in 2023 and is expected to reach USD 1.6 billion by 2032. This region is a significant market for Restoril due to the high prevalence of mental health disorders and the established healthcare infrastructure[1].

Competitive Landscape

Key Players

The competitive landscape of the benzodiazepine drugs market is characterized by the presence of established pharmaceutical companies such as Novartis AG, GlaxoSmithKline plc, Pfizer Inc., and Roche. These companies adopt various strategic initiatives like collaboration, global expansion, research and development, and regulatory compliance to maintain their market share[1].

Efficacy and Clinical Trials

Clinical Studies

Restoril has demonstrated efficacy in clinical studies, particularly in improving sleep parameters for patients with insomnia. Studies have shown a linear dose-response improvement in total sleep time, sleep latency, and the number of awakenings, with minimal residual medication effects and no significant impact on daytime alertness or performance[2][4].

Safety and Side Effects

While Restoril is generally well-tolerated, it carries risks such as abuse, misuse, and addiction, which can lead to overdose or death. Common side effects include drowsiness, headache, fatigue, nervousness, and dizziness. The drug is contraindicated in pregnant women and should be used cautiously in elderly and debilitated patients due to the risk of oversedation and other adverse reactions[2][3][4].

Financial Implications

Revenue Projections

Given the growth projections for the benzodiazepine drugs market, Restoril is likely to contribute significantly to the revenue of its manufacturers. The market's expected growth to USD 4 billion by 2032 indicates a robust financial trajectory for drugs like Restoril.

Cost and Pricing

The cost and pricing of Restoril can vary based on factors such as distribution channels, regional markets, and competition. However, the drug's efficacy and the growing demand for mental health treatments suggest that it will remain a profitable product for pharmaceutical companies.

Regulatory Considerations

FDA Warnings and Guidelines

Restoril, like other benzodiazepines, is subject to strict regulatory guidelines due to its potential for abuse and addiction. The FDA has issued warnings about the risks of concomitant use with opioids and the need for gradual tapering to avoid withdrawal reactions[2][3].

Key Takeaways

• The benzodiazepine drugs market, including Restoril, is driven by the increasing prevalence of anxiety disorders and insomnia.
• The market is expected to grow at a CAGR of 3.9% from 2024 to 2032.
• Restoril is primarily used for the short-term treatment of insomnia and falls under the short-acting benzodiazepine category.
• The drug has shown efficacy in clinical trials with minimal residual effects.
• Regulatory considerations, including FDA warnings about abuse and addiction, are crucial for its use.
• The competitive landscape is dominated by established pharmaceutical companies.

FAQs

Q: What is the primary indication for Restoril?

A: Restoril is primarily indicated for the short-term treatment of insomnia.

Q: What are the potential risks associated with Restoril?

A: Restoril carries risks such as abuse, misuse, and addiction, which can lead to overdose or death. It also has side effects like drowsiness, headache, and fatigue.

Q: How is the benzodiazepine drugs market expected to grow?

A: The benzodiazepine drugs market is expected to grow at a CAGR of 3.9% from 2024 to 2032, reaching USD 4 billion by 2032.

Q: Which segment holds the dominant market share in the benzodiazepine drugs market?

A: The short-acting segment, which includes Restoril, held a dominant market share of 55.3% in 2023.

Q: What are the regulatory considerations for Restoril?

A: Restoril is subject to strict regulatory guidelines due to its potential for abuse and addiction. The FDA has issued warnings about concomitant use with opioids and the need for gradual tapering to avoid withdrawal reactions.

Sources

1. GMI Insights: Benzodiazepine Drugs Market Size & Share | Growth Forecasts 2032
2. FDA: RESTORIL (TEMAZEPAM) Label
3. FDA: Restoril™ (temazepam) Capsules USP Rx only WARNING
4. Drugs.com: Restoril: Package Insert / Prescribing Information