MIDAZOLAM HYDROCHLORIDE - Generic Drug Details

What are the generic sources for midazolam hydrochloride and what is the scope of freedom to operate?

Midazolam hydrochloride is the generic ingredient in six branded drugs marketed by Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Epic Pharma Llc, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, Micro Labs, Ph Health, Rising, Onesource Specialty, HLR, Rafa Labs Ltd, MMT, Padagis Us, Pai Holdings, Pharm Assoc, Sun Pharm Inds Ltd, and Roche, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for MIDAZOLAM HYDROCHLORIDE

US Patents:	0
Tradenames:	6
Applicants:	25
NDAs:	40
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1,694
Patent Applications:	2,570
What excipients (inactive ingredients) are in MIDAZOLAM HYDROCHLORIDE?	MIDAZOLAM HYDROCHLORIDE excipients list
DailyMed Link:	MIDAZOLAM HYDROCHLORIDE at DailyMed

Recent Clinical Trials for MIDAZOLAM HYDROCHLORIDE

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

Sponsor	Phase
Ain Shams University	PHASE4
Janssen Research & Development, LLC	PHASE3
Thomas Jefferson University	PHASE4

See all MIDAZOLAM HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for MIDAZOLAM HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 5MG BASE/ML	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for MIDAZOLAM HYDROCHLORIDE

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for MIDAZOLAM HYDROCHLORIDE

Adjuvants, Anesthesia

Anesthetics, Intravenous

Anti-Anxiety Agents

GABA Modulators

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for MIDAZOLAM HYDROCHLORIDE

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

US Patents and Regulatory Information for MIDAZOLAM HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Inds Ltd	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	SYRUP;ORAL	076058-001	Mar 15, 2002		DISCN	No	No
Padagis Us	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	SYRUP;ORAL	076379-001	May 2, 2005	AA	RX	No	No
Gland Pharma Ltd	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	090850-001	Jan 25, 2012	AP	RX	No	No

Expired US Patents for MIDAZOLAM HYDROCHLORIDE

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

Market Dynamics and Financial Trajectory for Midazolam Hydrochloride

Last updated: July 27, 2025

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Introduction

Midazolam Hydrochloride, a short-acting benzodiazepine, serves critical roles in anesthesia, sedation, and other medical applications worldwide. Its unique pharmacological profile—rapid onset, short duration, and minimal respiratory depression—has cemented its importance across hospitals, clinics, and emergency settings. This article explores the evolving market dynamics, pricing trends, regulatory landscape, and future financial trajectory of Midazolam Hydrochloride, providing insights for stakeholders and investors.

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Market Overview

Midazolam Hydrochloride currently represents a significant segment of the global sedatives and anesthetic agents market, which was valued at approximately $10 billion in 2021, with a compound annual growth rate (CAGR) projected at about 4% from 2022 to 2027 [1]. Its formulation exists in multiple forms: injectable solutions, oral preparations, and nasal sprays—broadening its therapeutic applications.

Key end-users include hospitals (for procedural sedation and anesthesia), outpatient clinics, and EMS services. The rise in minimally invasive surgeries, emergency procedures, and preoperative anxiolysis cases has increased demand for Midazolam.

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Market Drivers

1. Expanding Medical Procedures

The upward trend in surgical procedures—especially outpatient and minimally invasive operations—has driven consistent demand for fast-acting, reliable sedatives like Midazolam. The COVID-19 pandemic further accelerated this trend due to increased ICU needs and ventilatory management protocols requiring sedation [2].

2. Growing Geriatric Population

The aging global population, particularly in North America and Europe, has escalated demand for sedation agents used in diagnostics and surgeries common among elderly patients. Midazolam's safety profile aligns with the needs of these demographics [3].

3. Regulatory Approvals and Off-label Uses

Ongoing regulatory approvals for novel formulations and expanding off-label uses—such as in pediatric sedation—provide new revenue streams. For example, nasal spray formulations have gained traction for rapid pre-hospital sedation [4].

4. Competitive Manufacturing Landscape

Several global pharmaceutical companies—Pfizer, Roche, and Sandoz—manufacture Midazolam, fostering competitive pricing and supply stability, which sustains market growth [5].

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Market Challenges

1. Regulatory and Patent Constraints

While generic production dominates, patent expirations have led to increased competition, exerting downward pressure on prices. Additionally, stringent regulatory standards for injectable sedatives in different jurisdictions add complexities.

2. Safety and Side Effect Profile

Despite its efficacy, Midazolam carries risks such as respiratory depression, especially in vulnerable populations. This necessitates cautious administration and enhances the importance of proper training, potentially increasing operational costs.

3. Competition from Alternatives

Emerging agents like Dexmedetomidine and Etomidate offer alternative sedative profiles with different safety and pharmacokinetic characteristics, challenging Midazolam’s market share in specific segments [6].

4. Supply Chain Disruptions

Global supply chain issues, notably during the pandemic, impacted raw material availability and manufacturing capacity, affecting product availability and pricing [7].

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Pricing Trends and Revenue Projections

Historical Pricing Dynamics:
Prices for Midazolam Hydrochloride have experienced moderate declines due to generic competition, with injectable formulations averaging $0.50 to $1.00 per dose in developed markets in 2022. Price erosion was approximately 3–5% annually over the past five years, consistent with typical generic drug market trends [8].

Future Revenue Outlook:
Despite price pressures, increasing volume sales are expected to sustain overall revenues, especially as global surgical volumes rise. The market for injectable sedatives is projected to grow at a CAGR of 3.5–4% through 2030, reaching an estimated $15 billion globally [1].

Regional Variations:
North America dominates sales (~45%), driven by high procedural volumes and advanced healthcare infrastructure. Asia-Pacific shows the highest growth potential (~6% CAGR), owing to expanding healthcare access and rising perioperative procedures [9].

Pricing Strategies:
Manufacturers are adopting value-based pricing for new formulations (e.g., nasal sprays), enabling premium pricing in specific niches. Contract-based discounts and tenders in hospitals further influence pricing dynamics.

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Regulatory and Patent Landscape

Patent Expiries and Generics:
Most patents for Midazolam formulations expired between 2018 and 2022, leading to a surge in generic entrants. While this increased competition suppresses prices, it also opens opportunities for cost-effective procurement in emerging markets.

Regulatory Approvals:
Organizations seek approvals for novel delivery systems—nanoparticle-based or intranasal formulations—to tap into unmet needs, supporting market expansion. Regulatory challenges remain, requiring adherence to safety standards and clinical trial validations.

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Future Financial Trajectory

Innovation and Pipeline Developments:
Investments in formulation innovations—like sustained-release injectables or combination therapies—have potential to command higher prices and expand applications, positively influencing future revenues.

Market Expansion in Emerging Economies:
Growing healthcare infrastructure and increasing procedural volumes in regions like Asia-Pacific and Latin America will drive volume growth. Strategic partnerships and local manufacturing are key to capturing market share.

Impact of Price Negotiations and Reimbursement Policies:
Government procurement policies and insurance coverage significantly influence sales. Price caps and formulary placements may impose margins compression but can be offset by high volume sales.

Commercial Risks:
Factors such as competition from new sedatives, regulatory delays, and supply chain vulnerabilities pose risks. Strategic diversification into related anesthetic agents can mitigate dependency.

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Conclusion

Midazolam Hydrochloride remains a cornerstone sedative and anesthetic with stable demand underpinning its market. While price pressures from generics and competition from emerging agents temper revenue growth margins, rising procedural volumes, demographic shifts, and formulation innovations forecast sustained financial trajectory. Stakeholders should align strategic investments with regional growth opportunities and regulatory landscapes to optimize profitability.

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Key Takeaways

• Growth Drivers: Increasing procedural volume, aging populations, expanding applications, and new formulations sustain demand.
• Pricing Trends: Marginal price declines due to generics are offset by volume growth, especially in emerging markets.
• Regulatory Landscape: Patent expiries open market for generics; innovation in formulations offers premium opportunities.
• Regional Outlook: North America dominates, with Asia-Pacific presenting high expansion potential.
• Strategic Focus: Innovation, regional expansion, and navigating regulatory pathways are critical to capitalizing on future opportunities.

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FAQs

1. How has patent expiration impacted Midazolam Hydrochloride market revenues?
Patent expiries have facilitated generic entry, leading to price reductions but increasing sales volume, thus stabilizing overall revenues.

2. What are the primary therapeutic applications driving demand for Midazolam?
Procedural sedation, anesthesia induction, ICU sedation, and preoperative anxiolysis are the main demand drivers.

3. How does competitive pressure from alternative sedatives influence market dynamics?
Emerging agents like dexmedetomidine challenge Midazolam's market share in certain applications, prompting innovation and differentiation.

4. What regional factors influence the growth of Midazolam Hydrochloride markets?
High procedural volumes, healthcare infrastructure, and regulatory environments favor North America and Europe; rapid market expansion in Asia-Pacific due to rising healthcare access.

5. What future innovations could impact the financial trajectory of Midazolam Hydrochloride?
Novel delivery systems, combination formulations, and targeted indications can increase pricing power and broaden usage.

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References

1. Global Market Insights. (2022). Sedatives and Anesthetics Market Size and Trends.
2. WHO. (2020). Global Surgical Volume and Trends.
3. United Nations. (2022). World Population Ageing.
4. FDA. (2021). Nasal Spray Sedative Approvals.
5. Pharmaceutical Tech. (2022). Major Manufacturers of Midazolam.
6. MarketWatch. (2021). Emerging Sedatives and Anesthetic Agents.
7. Supply Chain Dive. (2022). Impact of COVID-19 on Pharmaceutical Supply Chains.
8. MMIT. (2022). Pricing Trends in Generic Sedatives.
9. ICD-10 Data. (2022). Regional Healthcare Statistics.