VERSED Drug Patent Profile

Which patents cover Versed, and when can generic versions of Versed launch?

Versed is a drug marketed by HLR and Roche and is included in two NDAs.

The generic ingredient in VERSED is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Versed

A generic version of VERSED was approved as midazolam hydrochloride by FRESENIUS KABI USA on June 20^th, 2000.

Summary for VERSED

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	110
Patent Applications:	4,761
DailyMed Link:	VERSED at DailyMed

Recent Clinical Trials for VERSED

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

Sponsor	Phase
Stanford University	Phase 2
Lawson Health Research Institute	Phase 3
University of Texas Southwestern Medical Center	Phase 3

See all VERSED clinical trials

US Patents and Regulatory Information for VERSED

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-002	May 26, 1987		DISCN	Yes	No
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-001	Dec 20, 1985		DISCN	Yes	No
Roche	VERSED	midazolam hydrochloride	SYRUP;ORAL	020942-001	Oct 15, 1998		DISCN	Yes	No

Expired US Patents for VERSED

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-002	May 26, 1987	4,280,957*PED
Roche	VERSED	midazolam hydrochloride	SYRUP;ORAL	020942-001	Oct 15, 1998	4,280,957*PED
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-001	Dec 20, 1985	4,280,957*PED

International Patents for VERSED

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

Country	Patent Number	Title	Estimated Expiration
Denmark	157615
France	2288524
U.S.S.R.	725563	METHOD OF PREPARING IMIDAZO-(1,5-A)(1,4) DIAZEPINE DERIVATIVES OR THEIR SALTS
Israel	49161	IMIDAZO(1,5-A)(1,4)-DIAZEPINE DERIVATIVES,THEIR MANUFACTURE AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Austria	378959
United Kingdom	1519299
Hungary	174752	SPOSOB POLUCHENIJA PROIZVODNYKH IMIDAZO-KVADRATNAJA SKOBKA-1,5-A-KVADRATNAJA SKOBKA ZAKRYTA-KVADRATNAJA SKOBKA-1,4-KVADRATNAJA SKOBKA ZAKRYTA-DIAZEPINA (PROCESS FOR PRODUCING IMIDAZO-SQUARE BRACKET-1,5-A-SQUARE BRACKET CLOSED-SQUARE BRACKET-1,4-SQUARE BRACKET CLOSED-DIASEPINE DERIVATIVES)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: VERSED

Last updated: August 6, 2025

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Introduction

VERSED (midazolam hydrochloride injection) has established itself as a critical sedative and anxiolytic agent in medical settings. As an ultra-short-acting benzodiazepine, VERSED plays a pivotal role in anesthesia induction, procedural sedation, and critical care. This analysis explores the evolving market landscape, competitive positioning, regulatory environment, and the financial trajectory shaping VERSED’s future prospects. Given its broad application spectrum and ongoing innovations in sedation therapies, understanding the market dynamics surrounding VERSED is vital for stakeholders seeking strategic insights.

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Market Overview and Application Landscape

1. Clinical Utility and Market Penetration

VERSED’s primary indications include conscious sedation, preoperative sedation, and anesthesia induction. Its rapid onset and short duration of action make it a preferred choice among anesthesiologists and emergency clinicians. The drug’s versatility in both inpatient and outpatient settings underscores its extensive market penetration.

However, the dominant use in hospital environments is challenged by an increasingly competitive landscape, including alternative sedatives such as propofol, dexmedetomidine, and emerging agents with improved safety profiles. Nevertheless, VERSED remains entrenched due to its proven efficacy and familiarity among clinicians, supported by decades of clinical use.

2. Key Market Segments and Growth Drivers

• Hospitals and Surgical Centers: Constituting the primary revenue source, the rising volume of elective and emergency surgeries sustains demand.
• Intensive Care Units (ICUs): Continued ICU admissions and sedation protocols contribute substantially.
• Emergency Departments: The need for rapid sedation enhances the drug’s utility.

The global surgical market is expected to grow at a compound annual growth rate (CAGR) of 5.4% through 2028, propelled by increasing healthcare expenditure, aging populations, and expanding surgical procedures—factors directly supporting VERSED’s market.

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Competitive Landscape and Market Share

1. Main Competitors

While VERSED has maintained a market position largely due to its well-established safety and efficacy profile, it faces competition from:

• Propofol: Widely used for induction and maintenance of anesthesia, offering quicker recovery times.
• Dexmedetomidine: Preferred for sedation in ICU settings owing to its sedative and analgesic properties with fewer respiratory depressant effects.
• Etomidate and Ketamine: Alternative agents in specific clinical scenarios.

2. Market Share Dynamics

Generally, VERSED’s market share is influenced by hospital formularies, clinician preferences, and regulatory approvals. In North America, it holds a significant share given its longstanding clinical use. Nonetheless, shifts towards agents with better safety or recovery profiles could impact its dominance.

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Regulatory and Patent Environment

1. Patent Status and Approval Pathways

Midazolam’s patents have largely expired, leading to increased generic competition and downward price pressures. This commoditization restricts lucrative pharmaceutical exclusivity, impacting revenue growth prospects.

2. Regulatory Trends

Regulatory agencies like the FDA maintain stringent standards for sedation drugs, especially concerning safety and adverse event management. Any new formulations or delivery methods (e.g., nasal sprays, sublingual options) must navigate rigorous approval pathways, potentially affecting market entry timelines.

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Emerging Innovations and Market Trends

1. Novel Delivery Systems

Advancements include transdermal patches, nasal sprays, or auto-injectors aimed at enhancing ease of administration and reducing healthcare provider exposure. Such innovations could expand usage scenarios and streamline workflows.

2. Pharmacokinetic Optimization

Research into formulations with optimized onset and offset times or reduced adverse events (e.g., respiratory depression) aims to extend VERSED’s clinical utility and mitigate safety concerns.

3. Pharmacogenomics and Personalized Medicine

Understanding genetic factors influencing drug metabolism could enable tailored sedation protocols, influencing drug choice dynamics in specific patient populations.

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Financial Trajectory and Revenue Outlook

1. Revenue Trends

Historically, midazolam products, including VERSED, generated steady revenue streams largely driven by hospital orders. However, revenue growth has plateaued due to generic competition, with some regions experiencing price erosion.

2. Impact of Market Saturation and Generic Competition

The expiration of exclusivity rights diminishes profit margins, leading to price declines. For manufacturers to sustain revenue, diversification into new formulations or indications is critical.

3. Strategic Diversification and Portfolio Expansion

To foster financial growth, companies could leverage existing formulations to develop:

• Combination Therapies: Partnering with analgesics or adjunct agents.
• Alternative Administration Routes: Developing needle-free or rapid-onset options.

4. Pricing Strategies and Healthcare Economics

Negotiations with payers and hospitals influence profitability. Cost-saving initiatives and formulary negotiations remain vital amid a cost-conscious healthcare landscape.

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Regulatory and Market Challenges

1. Safety Concerns

Midazolam’s adverse effect profile, particularly respiratory depression, prompts cautious dosing protocols and monitoring requirements, potentially impacting utilization rates.

2. Regulatory Scrutiny

Regulatory agencies demand robust post-market surveillance, especially for newer formulations or delivery systems, which could delay market expansion.

3. Market Penetration in Emerging Economies

While developed markets are saturated, expanding into Asia, Latin America, and Africa presents opportunities but faces hurdles related to regulatory infrastructure, healthcare system disparities, and pricing sensitivities.

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Conclusion

The market landscape for VERSED is characterized by maturity, sustained demand within hospital settings, and increasing competition from alternative sedatives. Patent expirations and generics exert downward pressure on revenues, compelling manufacturers to innovate and diversify. Strategic focus on formulation advancements, safety profile improvements, and expanding into emerging markets will determine the drug's financial trajectory in the near to mid-term.

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Key Takeaways

• Steady Demand with Evolving Competition: VERSED remains essential for procedural sedation but faces increasing competition from agents like propofol and dexmedetomidine.
• Impact of Patent Expiry and Generic Competition: Revenue growth is constrained; innovation and portfolio expansion are crucial for maintaining profitability.
• Regulatory Environment as a Bottleneck and Opportunity: Stringent approval processes influence market entry for new formulations but also ensure safety standards, affecting adoption.
• Emerging Market Potential: Expanding into emerging economies offers growth avenues, albeit with regulatory and economic challenges.
• Innovation and Personalization: Formulation improvements and pharmacogenomic insights are key drivers for extending VERSED’s clinical and commercial relevance.

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FAQs

Q1: How does the expiration of midazolam patents influence VERSED’s market share?
A1: Patent expirations open the market to generic competitors, leading to significant price reductions and diminished profit margins for branded versions like VERSED, thereby increasing competition and pressuring market share.

Q2: What are the main clinical advantages of VERSED over other sedatives?
A2: VERSED offers rapid onset and brief duration of action, making it ideal for short procedures. Its familiarity among clinicians and well-established safety profile further strengthen its clinical utility.

Q3: Are there innovative formulations of VERSED in development?
A3: Yes, researchers and companies are exploring alternative delivery methods such as nasal powders, sublingual systems, and auto-injectors to improve usability and safety.

Q4: What market segments are expanding the usage of VERSED?
A4: Growing segments include outpatient surgery centers, emergency departments, and ICU sedation protocols, driven by rising procedural volumes and aging populations.

Q5: How might regulatory developments impact VERSED’s future?
A5: Stricter safety regulations or approval of new formulations could both challenge and create opportunities for VERSED’s market expansion, depending on how manufacturers adapt their portfolios.

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References

[1] Market research reports on anesthesia drugs and sedation agents.
[2] FDA approvals and guidelines on midazolam and sedative agents.
[3] Industry analyses on patent expirations and generic drug markets.
[4] Clinical studies comparing sedatives and their safety profiles.
[5] Healthcare industry forecasts on surgical and ICU procedure growth.

(Note: Actual citations are illustrative; specific sources should be referenced in detailed reports.)