MIDAZOLAM - Generic Drug Details

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

Midazolam is the generic ingredient in nine branded drugs marketed by Exela Pharma, Gland Pharma Ltd, Hikma, Inforlife, Ucb Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Endo Operations, Epic Pharma Llc, Fresenius Kabi Usa, 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-five NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for midazolam. Five suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for MIDAZOLAM

US Patents:	5
Tradenames:	9
Applicants:	28
NDAs:	45
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	1,499
Patent Applications:	7,028
Drug Prices:	Drug price trends for MIDAZOLAM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MIDAZOLAM
What excipients (inactive ingredients) are in MIDAZOLAM?	MIDAZOLAM excipients list
DailyMed Link:	MIDAZOLAM at DailyMed

See drug prices for MIDAZOLAM

Recent Clinical Trials for MIDAZOLAM

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 clinical trials

Generic filers with tentative approvals for MIDAZOLAM

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

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

Drug Class

Benzodiazepine

Anatomical Therapeutic Chemical (ATC) Classes for MIDAZOLAM

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

Paragraph IV (Patent) Challenges for MIDAZOLAM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NAYZILAM	Nasal Spray	midazolam	5 mg/spray	211321	1	2021-06-01

US Patents and Regulatory Information for MIDAZOLAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	216159-002	Apr 17, 2023	AP	RX	No	No
Hikma	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075324-001	Jun 20, 2000	AP	RX	No	No
Micro Labs	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	217504-001	Aug 21, 2023	AP	RX	No	No
Hospira	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075396-001	Jun 20, 2000		DISCN	No	No
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-001	Dec 20, 1985		DISCN	Yes	No
Apothecon	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075620-002	Nov 1, 2000		DISCN	No	No
Hospira	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	midazolam hydrochloride	INJECTABLE;INJECTION	075857-002	Jul 22, 2002	AP	RX	No	Yes

EU/EMA Drug Approvals for MIDAZOLAM

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Neuraxpharm Pharmaceuticals S.L.	Buccolam	midazolam	EMEA/H/C/002267 Treatment of prolonged, acute, convulsive seizures in infants, toddlers, children and adolescents (from three months to less than 18 years).Buccolam must only be used by parents / carers where the patient has been diagnosed to have epilepsy.For infants between three and six months of age, treatment should be in a hospital setting where monitoring is possible and resuscitation equipment is available.	Authorised	no	no	no	2011-09-04

MIDAZOLAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Midazolam

Introduction

Midazolam, a versatile benzodiazepine, is widely used in medical settings for sedation, anesthesia, and treating various conditions. The market for midazolam hydrochloride is experiencing significant growth, driven by several key factors.

Market Size and Growth Projections

The midazolam hydrochloride market is anticipated to exhibit robust growth from 2023 to 2031. According to market research, the market has encountered rapid and substantial growth in recent years and is expected to continue this trend. The forecast period suggests a sustained significant expansion, indicating strong growth rates[1][4].

Segmentation and Market Share

The midazolam hydrochloride market is segmented based on type (midazolam hydrochloride syrup and midazolam hydrochloride injection) and application (hospitals & clinics, pharmacy retail, and others). Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa.

• By Type: Midazolam hydrochloride injections are a dominant segment due to their widespread use in hospitals and clinics for sedation and anesthesia.
• By Application: Hospitals and clinics account for the largest share, given the frequent use of midazolam in these settings for patient care[1][4].

Key Drivers and Opportunities

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

• Increasing Demand in ICU Settings: The growing number of ICU patients, particularly elderly patients with respiratory and infectious diseases, is driving the demand for sedatives like midazolam. This trend is especially pronounced in regions like North America and Europe[3].
• Advancements in Healthcare Infrastructure: Developing healthcare infrastructure in emerging countries, such as those in the Asia-Pacific and Latin American regions, is contributing to the market's growth[3].
• Generic Products: The launch of generic midazolam products is expected to propel market growth by offering more affordable options[3].

Competitive Landscape

The midazolam hydrochloride market is characterized by the presence of both established and emerging players. Key companies include:

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

These companies are profiled based on their product offerings and market-related factors, including the year of market entry[1].

Financial Performance and Revenue

The financial trajectory of the midazolam hydrochloride market is marked by significant revenue growth. Here are some key financial insights:

• Revenue Growth: The market is expected to see substantial revenue growth during the forecast period, driven by the increasing demand for sedatives in ICU settings and other medical applications[1][4].
• Market Value: The market size is measured in USD million, with projections indicating a continued significant expansion from 2023 to 2031[1].

Challenges and Restraints

Despite the growth, the market faces several challenges:

• Generic Erosion: The entry of generic products can lead to price competition, affecting the revenue of branded products.
• Regulatory Hurdles: Strict regulatory environments and the need for continuous compliance can pose challenges for market players[1][3].

Regional Analysis

The midazolam hydrochloride market varies significantly across different regions:

• North America: This region is expected to hold a significant market share due to the strong presence of key market players and the high cost of sedatives.
• Europe: The rising ICU admissions of elderly patients with respiratory and infectious diseases are driving the market growth in this region.
• Asia-Pacific: Developing healthcare infrastructure and growing ICU admissions in emerging countries are key factors supporting market growth in this region[1][3].

Technological and Innovational Trends

The market is witnessing several technological and innovational trends:

• Ready-to-Use Formulations: The use of ready-to-use midazolam formulations can lead to economic savings and reduced consumption, enhancing patient care and efficiency[5].
• New Developments: Market players are focusing on new developments and innovations in sedation techniques to consolidate their market position[3].

Consumer Behavior and Economic Impact

Consumer behavior and economic factors play a crucial role in shaping the market:

• Economic Savings: The use of midazolam can result in significant economic savings, particularly with ready-to-use formulations.
• Consumer Preferences: The preference for safer, more potent, and affordable sedatives drives the demand for midazolam and other sedatives in ICU settings[3][5].

Key Takeaways

• The midazolam hydrochloride market is expected to experience robust growth from 2023 to 2031.
• The market is driven by increasing demand in ICU settings, advancements in healthcare infrastructure, and the launch of generic products.
• Key players include Hikma Pharmaceuticals, Pfizer, and Fresenius Kabi, among others.
• The market faces challenges such as generic erosion and regulatory hurdles.
• Regional growth varies, with North America and Europe being significant markets.

FAQs

Q: What are the primary segments of the midazolam hydrochloride market? A: The market is segmented by type (midazolam hydrochloride syrup and midazolam hydrochloride injection) and application (hospitals & clinics, pharmacy retail, and others)[1].

Q: Which region is expected to dominate the midazolam hydrochloride market? A: North America is expected to hold a significant market share due to the strong presence of key market players and the high cost of sedatives[1][3].

Q: What are the key drivers of the midazolam hydrochloride market? A: Key drivers include increasing demand in ICU settings, advancements in healthcare infrastructure, and the launch of generic products[1][3].

Q: Who are the major players in the midazolam hydrochloride market? A: Major players include Hikma Pharmaceuticals, Pfizer, Fresenius Kabi, Akorn Pharmaceuticals, and Gland Pharma, among others[1].

Q: What are the challenges faced by the midazolam hydrochloride market? A: The market faces challenges such as generic erosion, regulatory hurdles, and the need for continuous compliance with regulatory requirements[1][3].

Cited Sources

1. Market Research Intellect: Midazolam Hydrochloride Market Size, Scope And Forecast Report[1].
2. UCB: Strong first six months – UCB with continued delivery and strong resilience[2].
3. Fortune Business Insights: Sedation In ICU Setting Market Size and Forecast 2032[3].
4. Cognitive Market Research: Global Midazolam HCl Market Report 2024 Edition[4].
5. Value in Health: Ready-to-use midazolam formulations[5].