LORAZEPAM - Generic Drug Details

What are the generic drug sources for lorazepam and what is the scope of freedom to operate?

Lorazepam is the generic ingredient in six branded drugs marketed by Almatica, Amneal Pharms, Chartwell Molecular, Hikma, Lupin Ltd, Pharm Assoc, Bedford, Dr Reddys, Endo Operations, Epic Pharma Llc, Hospira, Intl Medication Sys, Rising, Watson Labs, Bedford Labs, Roxane, Bausch, Quantum Pharmics, Am Therap, Anda Repository, Ani Pharms, Aurolife Pharma Llc, Chartwell Rx, Halsey, Leading, Mutual Pharm, Oxford Pharms, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, and Warner Chilcott, and is included in seventy NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Lorazepam has thirty-five patent family members in thirty countries.

There are eleven drug master file entries for lorazepam. Thirty-seven suppliers are listed for this compound.

Summary for LORAZEPAM

International Patents:	35
US Patents:	1
Tradenames:	6
Applicants:	33
NDAs:	70
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	198
Patent Applications:	6,952
Drug Prices:	Drug price trends for LORAZEPAM
Drug Sales Revenues:	Drug sales revenues for LORAZEPAM
What excipients (inactive ingredients) are in LORAZEPAM?	LORAZEPAM excipients list
DailyMed Link:	LORAZEPAM at DailyMed

See drug prices for LORAZEPAM

See drug sales revenues for LORAZEPAM

Recent Clinical Trials for LORAZEPAM

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

Sponsor	Phase
California Institute of Technology	Phase 4
Laureate Institute for Brain Research, Inc.	Phase 4
BioXcel Therapeutics Inc	Phase 4

See all LORAZEPAM clinical trials

Pharmacology for LORAZEPAM

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for LORAZEPAM

Anti-Anxiety Agents

Anticonvulsants

Antiemetics

GABA Modulators

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for LORAZEPAM

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for LORAZEPAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	LORAZEPAM	lorazepam	INJECTABLE;INJECTION	074551-003	Sep 12, 1996		DISCN	No	No
Watson Labs	LORAZEPAM	lorazepam	TABLET;ORAL	071086-001	Mar 23, 1987		DISCN	No	No
Sandoz	LORAZEPAM	lorazepam	TABLET;ORAL	071195-001	Apr 15, 1988		DISCN	No	No

Expired US Patents for LORAZEPAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-001	Approved Prior to Jan 1, 1982
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-002	Approved Prior to Jan 1, 1982

International Patents for LORAZEPAM

Country	Patent Number	Title	Estimated Expiration
Spain	2856181
Brazil	112015016304	formulações de lorazepam de liberação sustentada
Japan	2017019880	ロラゼパムの徐放性製剤 (SUSTAINED RELEASE FORMULATIONS OF LORAZEPAM)

LORAZEPAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lorazepam

Introduction

Lorazepam, a benzodiazepine, is widely used for the treatment of anxiety disorders, insomnia, and other conditions such as seizure management and pre-procedural sedation. The market for lorazepam is experiencing significant growth, driven by several key factors.

Growing Prevalence of Anxiety Disorders

The increasing incidence of anxiety disorders is a major driver of the lorazepam market. Fast-paced lifestyles, financial pressures, and the impact of social media have all contributed to a rise in anxiety levels, leading to higher demand for effective anxiolytic drugs like lorazepam[2][4][5].

Aging Population

The growing older population is another significant factor. Older adults are at a higher risk of developing anxiety disorders and insomnia, which has resulted in increased prescription rates for lorazepam. This demographic shift is expected to continue driving market growth[2][4].

Reduced Stigma and Growing Awareness of Mental Health

There has been a notable reduction in the stigma associated with mental health issues, leading to more people seeking treatment for anxiety disorders. This increased awareness and acceptance of mental health concerns have boosted the demand for lorazepam and other benzodiazepines[2][4].

Market Segmentation

The lorazepam market is segmented based on several criteria:

By Application

• Anxiety Disorders
• Insomnia
• Epileptic State
• Other applications such as pre-procedural sedation and seizure management[1][2][3].

By Product

• Tablets
• Powder Injection
• Intravenous (IV) Injection
• Disintegrating Tablets[1][2].

By Distribution Channels

• Retail Pharmacies
• Hospitals & Clinics
• Online Pharmacies[2][4].

By Geography

• North America
• Europe
• Asia-Pacific
• South America
• Middle East and Africa[1][2][3].

Financial Trajectory

Market Size and Growth

The global lorazepam market is projected to experience substantial growth from 2024 to 2031. The market size is expected to expand significantly, driven by the factors mentioned above. For instance, the market is forecasted to undergo a detailed examination, predicting strong growth rates throughout the forecast period[1][2][3].

Revenue Analysis

The revenue analysis indicates that the lorazepam market will see significant growth, with projections suggesting a compound annual growth rate (CAGR) similar to that of the broader benzodiazepine market, which is expected to grow at a CAGR of 2.68% to 2.8% from 2024 to 2030[4][5].

Regional Performance

North America currently holds the largest market share due to substantial research investments and the presence of significant pharmaceutical corporations. However, the Asia-Pacific region is expected to grow at the fastest rate over the forecast period, driven by increasing healthcare needs and economic growth[4][5].

Competitive Landscape

The lorazepam market is highly competitive, with key players such as Pfizer Inc., Mylan N.V., Teva Pharmaceutical Industries Ltd., and others dominating the market. These companies are known for their broad distribution networks and high-quality standards. Recent acquisitions, such as Pfizer's acquisition of Seagen Inc., further highlight the competitive and dynamic nature of the market[2][4].

Key Players and Their Strategies

• Pfizer Inc.: Known for its wide range of medications, including lorazepam, and its strong distribution network.
• Mylan N.V.: Recognized for its generic lorazepam variants that prioritize accessibility and affordability.
• Teva Pharmaceutical Industries Ltd.: Active in developing and marketing various benzodiazepine medications, including lorazepam[2][4].

Challenges and Opportunities

Challenges

• Concerns about the excessive use of benzodiazepines and their potential for addiction are growing. This has led to initiatives to develop alternative drugs with lower risks of dependence and addiction[4][5].
• Regulatory scrutiny and the need for continuous innovation to maintain market share are other challenges faced by industry players.

Opportunities

• The development of new effective medications for seizures and other applications presents significant opportunities for growth.
• Increasing investments in healthcare R&D and the introduction of novel synthesized benzodiazepines are expected to fuel market growth[4][5].

Market Outlook

The market outlook for lorazepam is positive, driven by the increasing demand for anxiolytic and hypnotic medications. Here are some key trends and insights:

• Porter's 5 Forces Framework: This analysis highlights the competitive rivalry, bargaining power of suppliers and buyers, threat of new entrants, and the threat of substitute products, all of which play a pivotal role in shaping the market landscape[1].
• Value Chain Evaluation: This involves a comprehensive analysis of the entire value chain, from production to distribution, to understand the market dynamics better[1].

"The rising prevalence of anxiety disorders, growing awareness and reduced stigma, and the aging population are the major factors driving the lorazepam market."[2]

Key Takeaways

• The lorazepam market is driven by the increasing prevalence of anxiety disorders, an aging population, and reduced stigma around mental health.
• The market is segmented by application, product type, distribution channels, and geography.
• North America currently holds the largest market share, but the Asia-Pacific region is expected to grow rapidly.
• Key players are focusing on new product development, mergers and acquisitions, and strategic alliances to maintain market share.
• Challenges include concerns about addiction and regulatory scrutiny, while opportunities lie in the development of new medications and increasing healthcare investments.

FAQs

What are the primary drivers of the lorazepam market?

The primary drivers include the rising prevalence of anxiety disorders, growing awareness and reduced stigma around mental health, and the aging population.

Which region holds the largest market share for lorazepam?

North America currently holds the largest market share, but the Asia-Pacific region is expected to grow at the fastest rate over the forecast period.

What are the main challenges facing the lorazepam market?

Challenges include concerns about the excessive use and potential for addiction of benzodiazepines, as well as regulatory scrutiny and the need for continuous innovation.

Who are the key players in the lorazepam market?

Key players include Pfizer Inc., Mylan N.V., Teva Pharmaceutical Industries Ltd., and other major pharmaceutical companies.

What is the expected growth rate of the lorazepam market?

The market is expected to grow at a CAGR of 2.68% to 2.8% from 2024 to 2030.

Sources

1. Market Research Intellect: Global Lorazepam Market Size And Forecast 2[1]
2. HTF Market Intelligence: Lorazepam Market - Global Trend and Growth Outlook to 2030[2]
3. Wicz: Global Lorazepam Market Size: Future Demand and Leading Players Forecast 2024-2032[3]
4. Grand View Research: Benzodiazepine Drugs Market Size And Share Report, 2030[4]
5. Fact.MR: Benzodiazepine Drugs Market Size, Share & Growth Trajectory 2032[5]