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, Endo Operations, Epic Pharma Llc, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Hospira Inc, Igi Labs Inc, Intl Medicated, Intl Medication, Micro Labs, Rising, Steriscience Speclts, 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-five 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:	25
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	1,499
Patent Applications:	1,625
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
University of Alabama at Birmingham	Phase 1
Medical University of South Carolina	Phase 4
Ruijin Hospital	Phase 1/Phase 2

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
Fresenius Kabi Usa	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075154-001	Jun 20, 2000	AP	RX	No	No
Fresenius Kabi Usa	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075154-002	Jun 20, 2000	AP	RX	No	No
Baxter Hlthcare Corp	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075637-001	Oct 31, 2000		DISCN	No	No
Hikma	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075324-001	Jun 20, 2000	AP	RX	No	No
Epic Pharma Llc	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075494-002	Jun 30, 2000	AP	RX	No	No
Intl Medication	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	076020-002	Jul 16, 2004		DISCN	No	No
Hikma	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075324-002	Jun 20, 2000	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
Roche	VERSED	midazolam hydrochloride	SYRUP;ORAL	020942-001	Oct 15, 1998
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-001	Dec 20, 1985

MIDAZOLAM HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Midazolam Hydrochloride

Introduction

Midazolam hydrochloride, a benzodiazepine with sedative, anxiolytic, muscle relaxant, and anticonvulsant properties, has been a crucial component in the pharmaceutical industry, particularly in the fields of anesthesia and palliative care. Here, we delve into the market dynamics and financial trajectory of midazolam hydrochloride, highlighting key trends, drivers, and projections.

Market Size and Growth Projections

The midazolam hydrochloride market has experienced rapid and substantial growth in recent years. From 2023 to 2031, the market is expected to continue its significant expansion, driven by robust growth rates. The market size is anticipated to grow substantially, with the forecast period indicating a sustained upward trend in market dynamics[1].

Segmentation

The midazolam hydrochloride market is segmented based on several key factors:

By Type

• Midazolam Hydrochloride Syrup: This form is particularly used in pediatric and geriatric patients due to its ease of administration.
• Midazolam Hydrochloride Injection: Commonly used in hospitals and clinics for procedural sedation and anesthesia[1].

By Application

• Hospitals & Clinics: These settings are the primary users of midazolam hydrochloride, given its role in surgical procedures and emergency care.
• Pharmacy Retail: Available for prescription and over-the-counter in some regions.
• Others: Includes palliative care, home healthcare, and other medical facilities[1].

By Geography

• North America: Dominates the market due to its robust healthcare infrastructure and high prevalence of surgical procedures.
• Europe: Follows closely, driven by its well-established pharmaceutical industry and stringent regulatory framework.
• Asia-Pacific: Expected to grow significantly due to increasing healthcare expenditure and improving healthcare infrastructure.
• South America and Middle-East & Africa: Also show potential for growth, though at a slower pace[1][3].

Drivers of Growth

Several factors are driving the growth of the midazolam hydrochloride market:

Increasing Surgical Procedures

The rise in surgical operations, particularly in regions with aging populations and increasing chronic illnesses, is a significant driver. For instance, in the United States, the increasing prevalence of cancer and other chronic conditions necessitating surgery has boosted the demand for anesthesia drugs, including midazolam hydrochloride[3].

Technological Advancements

Improvements in anesthetic technology and the development of more efficient and safer anesthetic practices have enhanced the use of midazolam hydrochloride in various medical settings[3].

Expanding Healthcare Infrastructure

Investments in healthcare infrastructure, especially in North America and Europe, have significantly boosted the market. The construction of new hospitals and medical facilities has increased the demand for midazolam hydrochloride[3].

Restraints and Challenges

Despite the growth, there are several challenges facing the midazolam hydrochloride market:

Regulatory Framework

Stringent regulatory requirements can slow down the approval and launch of new formulations or uses of midazolam hydrochloride. This can impact market growth, especially in regions with strict healthcare regulations[1].

Economic Factors

The lack of healthcare services in low-income countries and distant locations affects the demand for anesthesia drugs, including midazolam hydrochloride. This gap in accessibility to essential medical services is a significant restraint[3].

Competitive Scenario

The midazolam hydrochloride market is competitive, with several key players:

• Hikma Pharmaceuticals
• Pfizer
• Fresenius Kabi
• Akorn Pharmaceuticals
• Gland Pharma
• PADAGIS
• Meridian Medical Technologies
• Alvogen
• Precision Dose Inc.[1]

These companies are profiled in market reports, which include details on their market entry year, product offerings, and other market-related factors.

Financial Projections

The financial trajectory of the midazolam hydrochloride market is promising:

• Market Size: The market is expected to grow from its current value to a significantly higher figure by 2031, with a robust growth rate during the forecast period[1].
• Revenue: The revenue generated from midazolam hydrochloride is anticipated to increase substantially, driven by the increasing demand in hospitals, clinics, and other healthcare settings[1].

Pharmacological and Clinical Aspects

Understanding the pharmacological properties of midazolam hydrochloride is crucial for its market dynamics:

• Pharmacokinetics: Midazolam exhibits linear pharmacokinetics between oral doses of 0.25 to 1.0 mg/kg. It is metabolized primarily by the liver and excreted by the kidneys. The α-hydroxy metabolite of midazolam is equipotent to the parent drug and plays a significant role in its pharmacodynamic effects[2][5].

Market Outlook

The market outlook for midazolam hydrochloride is positive, with several trends influencing its growth:

• General Anesthesia Drugs Market: The broader general anesthesia drugs market, of which midazolam hydrochloride is a part, is expected to grow from USD 4,978.1 million in 2023 to USD 6,898.4 million by 2033, with a CAGR of 3.3%[3].

Regional Insights

Regional dynamics play a significant role in the market:

• North America: Dominates the market due to its advanced healthcare infrastructure and high surgical procedure rates.
• Europe: Follows closely, driven by its well-established pharmaceutical industry.
• Asia-Pacific: Expected to grow rapidly due to increasing healthcare expenditure and improving infrastructure[1][3].

Key Takeaways

• The midazolam hydrochloride market is experiencing rapid growth driven by increasing surgical procedures and advancements in anesthetic technology.
• The market is segmented by type, application, and geography, with North America and Europe being key regions.
• Regulatory frameworks and economic factors are significant restraints.
• The competitive scenario is dominated by several major pharmaceutical companies.
• Financial projections indicate substantial growth in revenue during the forecast period.

FAQs

Q: What are the primary types of midazolam hydrochloride products in the market? A: The primary types are midazolam hydrochloride syrup and midazolam hydrochloride injection[1].

Q: Which regions dominate the midazolam hydrochloride market? A: North America and Europe dominate the market, driven by their robust healthcare infrastructure and well-established pharmaceutical industries[1][3].

Q: What are the key drivers of the midazolam hydrochloride market? A: Increasing surgical procedures, technological advancements in anesthesia, and expanding healthcare infrastructure are key drivers[3].

Q: How does the pharmacokinetics of midazolam hydrochloride vary across different patient groups? A: Midazolam exhibits linear pharmacokinetics across different age groups, but its metabolism and excretion can be affected by factors such as liver and renal function[5].

Q: What is the projected growth rate of the midazolam hydrochloride market from 2023 to 2031? A: The market is expected to experience robust growth rates during the forecast period, though the exact CAGR is not specified in the sources provided[1].

Sources

1. Market Research Intellect, "Midazolam Hydrochloride Market Size, Scope And Forecast Report", November 2024.
2. Eric Prommer, "Midazolam: an essential palliative care drug", 2020.
3. Future Market Insights, "General Anesthesia Drugs Market Size, Trends - 2033".
4. Market Research Reports, "Global Midazolam HCl Market Insights, Forecast to 2029".
5. Boehringer Ingelheim, "MIDAZOLAM HYDROCHLORIDE SYRUP CIV Rx only DESCRIPTION".