ATIVAN Drug Patent Profile

Which patents cover Ativan, and what generic alternatives are available?

Ativan is a drug marketed by Hikma and Bausch and is included in two NDAs.

The generic ingredient in ATIVAN is lorazepam. There are eleven drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the lorazepam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ativan

A generic version of ATIVAN was approved as lorazepam by SANDOZ on April 21^st, 1987.

Summary for ATIVAN

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	45
Patent Applications:	4,291
Drug Prices:	Drug price information for ATIVAN
What excipients (inactive ingredients) are in ATIVAN?	ATIVAN excipients list
DailyMed Link:	ATIVAN at DailyMed

See drug prices for ATIVAN

See drug sales revenues for ATIVAN

Recent Clinical Trials for ATIVAN

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

Sponsor	Phase
Johns Hopkins University	PHASE2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	PHASE2
Laureate Institute for Brain Research, Inc.	Phase 4

See all ATIVAN clinical trials

Pharmacology for ATIVAN

Drug Class

Benzodiazepine

US Patents and Regulatory Information for ATIVAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Bausch	ATIVAN	lorazepam	TABLET;ORAL	017794-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-002	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
Bausch	ATIVAN	lorazepam	TABLET;ORAL	017794-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Bausch	ATIVAN	lorazepam	TABLET;ORAL	017794-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes

Expired US Patents for ATIVAN

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	4,017,616
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-002	Approved Prior to Jan 1, 1982	4,017,616

International Patents for ATIVAN

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

Country	Patent Number	Title	Estimated Expiration
Ireland	38298	PARENTERAL BENZODIAZEPINE COMPOSITIONS
Germany	2302659
South Africa	7209004
Australia	461715
United Kingdom	1345510
Netherlands	7300694
France	2181679

Market Dynamics and Financial Trajectory for ATIVAN (Lorazepam)

Last updated: July 31, 2025

Introduction

ATIVAN, the brand name for lorazepam, is a benzodiazepine primarily prescribed for anxiety, sedation, and seizure management. As with many pharmaceuticals, its market trajectory is influenced by regulatory, clinical, and socio-economic factors. Analyzing its current market dynamics and financial outlook provides crucial insights for stakeholders, including investors, healthcare providers, and pharmaceutical companies.

Market Overview of ATIVAN

ATIVAN's market position is rooted in its long-established efficacy profile and FDA approval for multiple indications. However, the evolving landscape of psychotropic medications, regulatory scrutiny over benzodiazepines, and the rise of alternative therapies influence its sales and utilization.

Therapeutic Indications & Patient Demographics

Lorazepam is primarily used in acute anxiety states, preoperative sedation, and status epilepticus. The aging global population and increasing prevalence of anxiety disorders bolster demand, particularly in aging patient populations prone to comorbidities requiring such medications.

Regulatory Environment & Prescribing Trends

Regulatory bodies exert significant influence:

• FDA Regulations: Strict controls on benzodiazepine prescriptions due to abuse potential [1].
• Controlled Substance Scheduling: Lorazepam's classification as a Schedule IV drug limits overprescription but maintains steady demand in appropriate clinical contexts.
• Opioid Crisis Impact: Heightened awareness around dependency risks has led to cautious prescribing, dampening growth prospects in some regions.

Market Competition & Alternatives

The market features several alternatives, including SSRIs, SNRIs, and non-benzodiazepine sedatives like zolpidem. The popularity of these options, often associated with fewer dependency concerns, poses challenges for ATIVAN's market share.

Emerging Market Opportunities

Growing awareness and expanding mental health services in emerging markets are opening new avenues. However, regulatory and economic barriers slow penetration.

Market Dynamics Influencing ATIVAN

Prescribing Patterns & Clinical Guidelines

Clinical guidelines now favor non-benzodiazepine options for long-term anxiety management, which constrains ATIVAN's usage primarily to short-term or acute care scenarios [2].

Public and Political Scrutiny

Heightened concerns over benzodiazepine misuse lead to tighter prescribing restrictions, prescription monitoring programs, and public health campaigns aimed at reducing dependency.

Generic Availability & Pricing Pressures

Generic lorazepam’s patent expiration has significantly increased market competition, exerting downward pressure on pricing and profit margins for brand-name ATIVAN.

Supply Chain & Manufacturing Factors

Manufacturing complexity, along with potential shortages of raw materials, can impact availability, influencing sales volumes and revenue stability.

Financial Trajectory Analysis

Historical Revenue & Sales Data

Historically, ATIVAN has demonstrated steady but modest sales, mostly driven by hospital and emergency settings. The expiration of patent protections and the rise of generics have led to revenue declines for the brand but bolstered volume sales.

Profitability & Cost Considerations

Brand-name ATIVAN faces stiff price competition. Margins have narrowed, especially as healthcare payers favor cost-effective generics, pressuring branded sales.

Forecasting Future Revenue

Factors influencing future revenue include:

• Regulatory restrictions: Could further curtail prescriptions.
• Prescribing trends: A shift towards non-benzodiazepine alternatives.
• Generic penetration: Continues to dominate, with generic lorazepam accounting for the majority of sales.
• Potential new formulations: Extended-release or combination products could sustain some demand.

Analysts project limited growth prospects over the next five years under current market conditions but recognize niche applications and hospital usage maintain baseline sales stability [3].

Investment Outlook

Given the constraints, pharmaceutical companies focusing on ATIVAN may see declining revenues unless they innovate or expand into new indications. Strategic focus on differentiating formulations or combination therapies may mitigate some market pressures.

Future Trends & Strategic Considerations

Shift to Digital & Alternative Therapies

Digital therapeutics and psychotherapy are increasingly substituting pharmacological solutions for anxiety, potentially reducing reliance on medications like ATIVAN.

Regulatory & Policy Drivers

Efforts to combat the opioid epidemic have catalyzed stricter benzodiazepine regulations, which could further limit market growth.

Potential for Market Expansion in Niche Sectors

Hospital infusion protocols and emergency protocols continue to necessitate benzodiazepines, suggesting niche but resilient demand.

Innovation & New Formulations

Development of abuse-deterrent formulations or alternative delivery systems could preserve some market value.

Key Takeaways

• ATIVAN’s market faces headwinds from regulatory restrictions, competition from generics, and shifting clinical guidelines favoring non-benzodiazepines.
• Demand remains stable primarily within acute care settings, but long-term growth prospects are limited.
• Revenue and profitability are pressured by generic competition, emphasizing the importance of innovation and strategic diversification.
• Emerging markets and niche healthcare settings sustain some sales, but overall trajectory suggests a plateau or gradual decline.
• Stakeholders should consider these dynamics when assessing investment, clinical, or manufacturing strategies related to lorazepam.

FAQs

1. What factors are driving the decline in ATIVAN’s market share?
Regulatory restrictions, societal concerns about dependence, competition from non-benzodiazepine agents, and the proliferation of generics have collectively constrained ATIVAN’s market share.

2. How does the patent expiration of lorazepam impact its market?
Patent expiration has led to a surge in generic equivalents, significantly reducing prices of brand-name ATIVAN and affecting profit margins for original manufacturers.

3. Are there new formulations of lorazepam being developed?
While some efforts explore abuse-deterrent formulations, no major new formulations are currently in advanced development, limiting innovation-driven growth.

4. What is the role of emerging markets in ATIVAN’s future?
Emerging markets present growth opportunities due to expanding mental health services, but regulatory hurdles and pricing sensitivity temper potential gains.

5. How might healthcare policies influence ATIVAN’s future sales?
Policies emphasizing medication safety and prescribing restrictions will likely continue to limit long-term utilization and push toward alternative therapies.

Sources

1. U.S. Food and Drug Administration. (2022). Benzodiazepine Drugs.
2. American Psychiatric Association. (2020). Clinical Practice Guideline for the Treatment of Anxiety Disorders.
3. MarketWatch. (2022). Global Benzodiazepines Market Overview.