Temazepam - Generic Drug Details

What are the generic drug sources for temazepam and what is the scope of patent protection?

Temazepam is the generic ingredient in three branded drugs marketed by Specgx Llc, Quantum Pharmics, Actavis Elizabeth, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Usa, Chartwell Rx, Duramed Pharms Barr, Novel Labs Inc, Prinston Inc, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for temazepam. Twenty-seven suppliers are listed for this compound.

Summary for temazepam

US Patents:	0
Tradenames:	3
Applicants:	14
NDAs:	24
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	9
Patent Applications:	6,523
Drug Prices:	Drug price trends for temazepam
Drug Sales Revenues:	Drug sales revenues for temazepam
What excipients (inactive ingredients) are in temazepam?	temazepam excipients list
DailyMed Link:	temazepam at DailyMed

See drug prices for temazepam

See drug sales revenues for temazepam

Recent Clinical Trials for temazepam

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

Sponsor	Phase
Turku University Hospital	Phase 4
Saint-Joseph University	Phase 3
Hannover Medical School	Phase 3

See all temazepam clinical trials

Pharmacology for temazepam

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for temazepam

Anti-Anxiety Agents

GABA Modulators

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for temazepam

N05CD	Benzodiazepine derivatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for TEMAZEPAM

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 temazepam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alkem Labs Ltd	TEMAZEPAM	temazepam	CAPSULE;ORAL	217875-003	Aug 24, 2023	AB	RX	No	No
Alkem Labs Ltd	TEMAZEPAM	temazepam	CAPSULE;ORAL	217875-002	Aug 24, 2023	AB	RX	No	No
Specgx Llc	RESTORIL	temazepam	CAPSULE;ORAL	018163-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Aurobindo Pharma Usa	TEMAZEPAM	temazepam	CAPSULE;ORAL	070920-002	May 21, 2010		DISCN	No	No
Alkem Labs Ltd	TEMAZEPAM	temazepam	CAPSULE;ORAL	217875-001	Aug 24, 2023	AB	RX	No	No
Usl Pharma	TEMAZEPAM	temazepam	CAPSULE;ORAL	070490-001	Jul 7, 1986		DISCN	No	No
Chartwell Rx	TEMAZEPAM	temazepam	CAPSULE;ORAL	071428-001	Jan 12, 1988	AB	RX	No	No

Expired US Patents for temazepam

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

Temazepam Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Temazepam

Introduction to Temazepam

Temazepam, a member of the benzodiazepine class, is widely used for the treatment of insomnia and other sleep disorders. It is also utilized in managing anxiety and as a preoperative sedative. Understanding the market dynamics and financial trajectory of temazepam is crucial for pharmaceutical companies, investors, and healthcare professionals.

Global Benzodiazepine Market Overview

The global benzodiazepine market, which includes temazepam, is experiencing significant growth driven by several key factors.

• Rising Prevalence of Mental Health Disorders: The increasing cases of anxiety, insomnia, and other mental health issues are driving the demand for benzodiazepines, including temazepam[2][4].
• Growing Geriatric Population: The elderly population is more prone to sleep disorders and anxiety, contributing to the increased use of temazepam[4].
• Favorable Reimbursement Policies: Positive reimbursement policies in many regions are making benzodiazepines more accessible, thereby boosting their market growth[4].

Market Size and Growth Rate

Global Benzodiazepine Market

The global benzodiazepine market, which encompasses temazepam, was valued at approximately $2.35 billion in 2022 and is forecasted to reach $3.1 billion by 2032, growing at a compound annual growth rate (CAGR) of 2.8% from 2022 to 2032[2].

Temazepam Market Specifics

While the global temazepam market size for 2023 is not explicitly stated, it is part of the broader benzodiazepine market. The 7.5mg segment of temazepam, in particular, accounted for a noticeable share of the global temazepam market in 2023 and is projected to experience significant growth in the near future[1].

Regional Analysis

North America

North America is the most favorable regional market for benzodiazepine drugs, including temazepam, due to high prevalence rates of mental health disorders and favorable healthcare policies. This region accounted for approximately 37.2% of the global benzodiazepine market share in 2021[2].

Other Regions

Asia-Pacific is expected to be the fastest-growing region in the forecast period, driven by increasing awareness about mental health and growing healthcare infrastructure. Europe and other regions also contribute significantly to the global market, with Europe expected to grow at a CAGR of 2.5% from 2022 to 2032[2][4].

Applications and End Users

Applications

Temazepam is primarily used for treating insomnia, anxiety disorders, and as a preoperative sedative. The demand for temazepam is also driven by its use in managing alcohol withdrawal symptoms and seizures[2][4].

End Users

The primary end users of temazepam include hospitals, homecare settings, and specialty clinics. The hospital segment is expected to expand significantly, retaining its position throughout the forecast period[1][4].

Competitive Landscape

Key companies in the temazepam market are focusing on strategy building to strengthen their product portfolios and expand their business globally. Companies such as Ascend Laboratories, Mylan, and others are prominent players in this market[1].

Market Drivers and Restraints

Drivers

• Increasing Mental Health Issues: Rising cases of anxiety, insomnia, and other mental health disorders are driving the demand for temazepam.
• Healthcare R&D Investments: Investments in healthcare research and development have led to the introduction of novel synthesized benzodiazepines, including improved formulations of temazepam.
• Favorable Reimbursement Policies: Positive reimbursement policies make temazepam more accessible to patients[2][4].

Restraints

• Side Effects and Dependency: Long-term use of temazepam is associated with side effects such as memory loss, dependence, and addiction, which can restrain market growth.
• Regulatory Measures: Regulatory and legislative measures to limit monthly benzodiazepine use can impact the market negatively[3].

Financial Expenditure and Economic Burden

The total projected financial expenditure for benzodiazepines, including temazepam, is significant. For instance, in Croatia, the total projected financial expenditure for benzodiazepines is estimated at 14.22 million euros by 2032, with diazepam and alprazolam being major contributors[3].

Future Market Opportunities

Short Term (2022 to 2025)

• The rising use of benzodiazepines for mental disorders will favorably affect market growth.
• Product development with minimal side effects will lead to increased acceptance of temazepam[2].

Medium Term (2025 to 2028)

• Combination therapies with benzodiazepines and the development of sublingual and transdermal formulations will drive market growth.
• Increasing utilization of biofeedback and neurofeedback techniques will also contribute to the market expansion[4].

Long Term (2028 to 2032)

• Rising urbanization and extraordinary work pressure will drive market growth over the long term.
• Emphasis on personalized medicine approaches and expanding indications for benzodiazepine use will further boost the market[2][4].

Key Takeaways

• The global benzodiazepine market, including temazepam, is expected to grow at a CAGR of 2.8% from 2022 to 2032.
• North America is the largest market for benzodiazepines, with Asia-Pacific expected to be the fastest-growing region.
• Temazepam is primarily used for treating insomnia and anxiety disorders.
• The market is driven by increasing mental health issues and healthcare R&D investments, but restrained by side effects and regulatory measures.
• Future market opportunities include product development, combination therapies, and personalized medicine approaches.

FAQs

Q: What is the projected market size of the global benzodiazepine market by 2032?

The global benzodiazepine market is forecasted to reach $3.1 billion by 2032[2].

Q: Which region is expected to be the fastest-growing for benzodiazepine drugs?

Asia-Pacific is expected to be the fastest-growing region for benzodiazepine drugs in the forecast period[2][4].

Q: What are the primary applications of temazepam?

Temazepam is primarily used for treating insomnia, anxiety disorders, and as a preoperative sedative, as well as managing alcohol withdrawal symptoms and seizures[2][4].

Q: What are the major restraints on the temazepam market?

Major restraints include side effects such as memory loss, dependence, and addiction, as well as regulatory measures to limit benzodiazepine use[3].

Q: Which companies are key players in the temazepam market?

Key companies include Ascend Laboratories, Mylan, and others that are focusing on strategy building to strengthen their product portfolios[1].

Sources

1. Global Temazepam Capule Market Report 2024 Edition - Cognitive Market Research
2. Benzodiazepine Drugs Market Size, Share & Growth Trajectory 2032 - Fact.MR
3. Evolving Trends and Economic Burden of Benzodiazepine Use - PubMed
4. Global Benzodiazepine Drugs Market Report 2024 - The Business Research Company