Oxazepam - Generic Drug Details

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

Oxazepam is the generic ingredient in three branded drugs marketed by Actavis Elizabeth, Am Therap, Epic Pharma Llc, Ivax Sub Teva Pharms, Mylan, Trupharma, Watson Labs, Watson Labs Teva, Alpharma Us Pharms, Quantum Pharmics, Parke Davis, and Sun Pharm Industries, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for oxazepam. Four suppliers are listed for this compound.

Summary for oxazepam

US Patents:	0
Tradenames:	3
Applicants:	12
NDAs:	24
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	15
Patent Applications:	6,909
Drug Prices:	Drug price trends for oxazepam
What excipients (inactive ingredients) are in oxazepam?	oxazepam excipients list
DailyMed Link:	oxazepam at DailyMed

See drug prices for oxazepam

Recent Clinical Trials for oxazepam

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 2
Rose Research Center, LLC	Phase 1/Phase 2
Foundation for a Smoke-Free World	Phase 1/Phase 2

See all oxazepam clinical trials

Pharmacology for oxazepam

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for oxazepam

Anti-Anxiety Agents

GABA Modulators

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for oxazepam

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for oxazepam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	OXAZEPAM	oxazepam	CAPSULE;ORAL	071715-001	Oct 20, 1987		DISCN	No	No
Mylan	OXAZEPAM	oxazepam	CAPSULE;ORAL	071714-001	Oct 20, 1987		DISCN	No	No
Am Therap	OXAZEPAM	oxazepam	CAPSULE;ORAL	071955-001	Mar 3, 1988		DISCN	No	No
Watson Labs Teva	OXAZEPAM	oxazepam	CAPSULE;ORAL	072952-001	Sep 28, 1990		DISCN	No	No
Mylan	OXAZEPAM	oxazepam	CAPSULE;ORAL	071713-001	Oct 20, 1987		DISCN	No	No
Quantum Pharmics	ZAXOPAM	oxazepam	CAPSULE;ORAL	070640-001	Mar 1, 1988		DISCN	No	No
Trupharma	OXAZEPAM	oxazepam	CAPSULE;ORAL	071026-001	Aug 10, 1987	AB	RX	No	No

Expired US Patents for oxazepam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alpharma Us Pharms	SERAX	oxazepam	CAPSULE;ORAL	015539-002	Approved Prior to Jan 1, 1982	4,620,974
Alpharma Us Pharms	SERAX	oxazepam	CAPSULE;ORAL	015539-006	Approved Prior to Jan 1, 1982	4,620,974
Alpharma Us Pharms	SERAX	oxazepam	CAPSULE;ORAL	015539-004	Approved Prior to Jan 1, 1982	4,620,974

Oxazepam Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Oxazepam

Overview of Oxazepam

Oxazepam is a benzodiazepine used in the treatment of anxiety disorders, insomnia, and alcohol withdrawal symptoms. It works by enhancing the effect of the neurotransmitter gamma-aminobutyric acid (GABA) in the brain, which helps to reduce neuronal excitability and produce calming effects[4].

Market Size and Growth

The global benzodiazepine drugs market, which includes oxazepam, is projected to experience significant growth over the coming years.

• The benzodiazepine drugs market was valued at USD 2.8 billion in 2023 and is expected to reach USD 4 billion by 2032, growing at a CAGR of 3.9%[1].
• Alternatively, another forecast suggests the market will reach USD 3.1 billion by 2032, growing at a CAGR of 2.8% from 2022 to 2032[3].

Drivers of Market Growth

Several factors are driving the growth of the benzodiazepine market, including oxazepam:

Increasing Prevalence of Mental Health Disorders

The rising incidence of anxiety disorders and insomnia worldwide is a significant driver. For instance, an estimated 31.1% of U.S. adults experience some form of anxiety disorder at some time in their lives, according to the National Institute of Mental Health (NIMH)[1].

Growing Acceptance of Pharmacological Interventions

There is an increasing acceptance of pharmacological treatments for mental health conditions, which contributes to the market growth. This includes the use of benzodiazepines like oxazepam for anxiety and insomnia[1].

Aging Population

The aging population is more susceptible to anxiety and sleep disorders, leading to higher prescription rates of benzodiazepines. Oxazepam, in particular, is used extensively in elderly patients and those with impaired hepatic function[4].

Research and Development

Ongoing research and development focused on novel formulations and indications for benzodiazepines are expected to drive market growth. For example, the approval of new benzodiazepine products, such as Loreev XR, which received FDA approval in 2021, contributes to this growth[3].

Market Segmentation

Product Segment

Oxazepam is part of the broader benzodiazepine market, which is segmented into various products. Alprazolam dominates the market, but oxazepam and other benzodiazepines also hold significant shares. The market share of oxazepam, while not as high as alprazolam, is still substantial due to its widespread use in treating anxiety, insomnia, and alcohol withdrawal[1][3].

Indication Segment

The benzodiazepine market is segmented by indication, with anxiety being a major segment. Oxazepam is specifically used for mild to moderate anxiety and severe anxiety or alcohol withdrawal symptoms. The anxiety segment is expected to reach USD 1.45 billion by 2032[1].

Route of Administration

Oxazepam is primarily administered orally, which is the dominant route of administration in the benzodiazepine market. The oral segment held the highest market share in 2023 and is anticipated to grow at a CAGR of 3.7% between 2024 and 2032[1].

Regional Market

North America

North America is a significant market for benzodiazepine drugs, including oxazepam. In 2023, North America held a market share of 41.8% in the global benzodiazepine drugs market and is expected to reach USD 1.6 billion by 2032[1].

Competitive Landscape

The benzodiazepine market, including oxazepam, 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 product diversification to maintain a competitive edge[1].

Financial Trajectory

Revenue Projections

The global benzodiazepine market, which includes oxazepam, is expected to grow significantly. Here are some key financial projections:

• The market is expected to reach USD 4 billion by 2032, growing at a CAGR of 3.9% from 2023 to 2032[1].
• Alternatively, the market is forecasted to reach USD 3.1 billion by 2032, growing at a CAGR of 2.8% from 2022 to 2032[3].

Segment-Specific Growth

The anxiety segment, which is a significant indication for oxazepam, is expected to reach USD 1.45 billion by 2032. This indicates strong revenue potential for oxazepam and other benzodiazepines used in treating anxiety disorders[1].

Challenges and Opportunities

Side Effects and Dependency

One of the challenges facing the benzodiazepine market, including oxazepam, is the potential for side effects and dependency. This has led to a focus on developing novel formulations with minimal side effects, which presents an opportunity for growth as these new products gain acceptance[3].

Regulatory Approvals

The approval of new benzodiazepine products by regulatory bodies is a significant opportunity for market growth. For instance, the FDA approval of Loreev XR in 2021 highlights the ongoing support for innovative benzodiazepine treatments[3].

Key Takeaways

• The benzodiazepine market, including oxazepam, is driven by the increasing prevalence of mental health disorders, growing acceptance of pharmacological interventions, and an aging population.
• Oxazepam is used extensively for anxiety, insomnia, and alcohol withdrawal symptoms.
• The market is expected to grow significantly, with projections reaching USD 4 billion by 2032.
• North America is a key regional market, and established pharmaceutical companies dominate the competitive landscape.
• Ongoing research and development, along with regulatory approvals, are crucial for market growth.

FAQs

What are the primary indications for oxazepam?

Oxazepam is primarily used for the treatment of anxiety disorders, insomnia, and alcohol withdrawal symptoms[4].

How is the global benzodiazepine market expected to grow?

The global benzodiazepine market is expected to reach USD 4 billion by 2032, growing at a CAGR of 3.9% from 2023 to 2032[1].

Which region dominates the benzodiazepine market?

North America holds a significant market share, with 41.8% of the global benzodiazepine market in 2023 and expected to reach USD 1.6 billion by 2032[1].

What are the key drivers of the benzodiazepine market growth?

Key drivers include the increasing prevalence of anxiety disorders and insomnia, growing acceptance of pharmacological interventions, and an aging population[1].

Which companies are major players in the benzodiazepine market?

Major players include Novartis AG, GlaxoSmithKline plc, Pfizer Inc., and Roche[1].

Sources

1. Benzodiazepine Drugs Market Size & Share | Growth Forecasts 2032 - GMI Insights
2. The ASAM Clinical Practice Guideline on Alcohol Withdrawal - American Society of Addiction Medicine
3. Benzodiazepine Drugs Market Size, Share & Growth Trajectory 2032 - Fact.MR
4. Oxazepam - Some Pharmaceutical Drugs - NCBI Bookshelf