MIDAZOLAM - Generic Drug Details

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

Midazolam is the generic ingredient in nine branded drugs marketed by B Braun Medical, Exela Pharma, Gland, Hikma, Inforlife, Ucb Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Ben Venue, Epic Pharma Llc, Fresenius Kabi Usa, Gland Pharma Ltd, 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-six 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. Seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for MIDAZOLAM

US Patents:	5
Tradenames:	9
Applicants:	30
NDAs:	46
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	1,692
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
Ain Shams University	PHASE4
Thomas Jefferson University	PHASE4
Chinese University of Hong Kong	NA

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
Fresenius Kabi Usa	MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	midazolam hydrochloride	INJECTABLE;INJECTION	203460-002	Aug 22, 2014	AP	RX	No	No
Rising	MIDAZOLAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	075494-001	Jun 30, 2000	AP	RX	No	No
Ucb Inc	NAYZILAM	midazolam	SPRAY;NASAL	211321-001	May 17, 2019		RX	Yes	Yes			Y

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/002267Treatment 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

Market Dynamics and Financial Trajectory for Midazolam

Last updated: November 24, 2025

Introduction

Midazolam, a short-acting benzodiazepine, is predominantly employed for anesthesia, sedation, and status epilepticus management. Since its synthesis in the 1970s, midazolam has cemented its position within critical care and procedural sedation, making it a focus of ongoing market and financial analysis amid evolving healthcare needs, regulatory environments, and competitive landscapes.

Market Overview and Growth Drivers

The global pharmaceutical market for midazolam is driven by several key factors:

• Rising Prevalence of Critical Conditions: Increasing incidence of status epilepticus, anxiety disorders, and surgical procedures fuel demand for effective sedatives like midazolam [1].

• Expanding Hospital and Procedural Sedation Needs: The growing adoption of minimally invasive surgeries and outpatient procedures necessitates reliable sedation agents. Midazolam’s rapid onset and short duration make it favorable in outpatient and emergency settings [2].

• Aging Population: Elderly populations are more prone to neurological and cardiovascular conditions requiring sedation or anesthesia, augmenting demand within developed and developing markets.

• COVID-19 Impact: The pandemic heightened clinical needs for sedation in intensive care units (ICUs), temporarily boosting midazolam utilization.

• Regulatory Approvals and Formulation Innovations: Recently approved or reformulated midazolam products (e.g., nasal sprays, ready-to-use injectables) aim to improve stability, ease of administration, and broaden application scopes.

Competitive Landscape

Major players include combination of large pharmaceutical firms like Roche, Fresenius Kabi, and specialty manufacturers such as Hospira. Generic manufacturers have increased their market share post-patent expiries, intensifying price competition.

Emerging small-to-medium enterprises focus on novel formulations and delivery systems—e.g., intranasal, buccal—that target outpatient and prehospital use, which can disrupt traditional sales patterns.

Regulatory Environment

Strict regulatory standards in regions like the U.S. (FDA) and Europe (EMA) influence manufacturing, marketing, and distribution. Recent concerns regarding dependency and abuse potential necessitate rigorous monitoring, shaping future approvals and sales restrictions.

Market Challenges and Risks

• Regulatory and Legal Risks: Potential restrictions or reclassification due to misuse may reduce market access.

• Competitive Substitutes: Alternatives such as lorazepam or diazepam, and non-benzodiazepine sedatives, pose substitution risks.

• Pricing Pressures: Governments’ emphasis on cost containment pressures profitability, especially amid generic competition.

• Supply Chain Disruptions: Raw material shortages and manufacturing delays affect market availability and revenue forecasts.

Financial Trajectory and Revenue Outlook

Forecasts project moderate growth trajectories over the next five years, with compound annual growth rates (CAGRs) estimated between 3-6% globally. The trajectory varies by region:

• North America: Dominates the market through extensive healthcare infrastructure and procedural volume; growth influenced by ICU sedative needs and regulatory approvals.

• Europe: Steady demand driven by aging demographics but constrained by austerity measures and pricing pressures.

• Asia-Pacific: Rapid growth potential due to expanding healthcare infrastructure, increasing procedural volume, and government investments; however, regulatory challenges may temper expansion.

Revenue streams for pharmaceutical companies are expected to benefit from new formulations, expanded indications, and increased procedural adoption. Price erosion is probable for established formulations due to generics, though innovative delivery methods can propagate premium pricing.

Potential for Market Expansion

Emerging applications, such as pediatric sedation, prehospital emergency use, and intuitive delivery systems, may unlock incremental revenues. Regulatory approvals for generic or biosimilar versions are expected to catalyze market penetration but could compress margins.

Conclusion

The midazolam market is poised for steady growth, sustained by clinical demand for sedation agents aligned with increasing healthcare activity. Competitive innovation, regulatory navigation, and geographic expansion will underpin revenue trajectories. Companies investing in novel formulations and expanding into emerging markets are well-positioned to capitalize on the ongoing demand.

---

Key Takeaways

• Steady Demand Growth: Rising procedural and critical care procedures globally sustain midazolam's market presence.

• Innovation Drives Revenue: Novel delivery systems and expanded indications offer premium pricing opportunities.

• Regulatory Dynamics: Market expansion hinges on regulatory approval and control measures surrounding misuse.

• Competitive Landscape: Generic competition persists, but innovation and formulation improvements provide differentiation.

• Regional Opportunities: Asia-Pacific and emerging markets present significant growth prospects amid healthcare expansion.

---

FAQs

1. What are the primary clinical indications for midazolam?
   Midazolam is used for anesthesia induction, procedural sedation, and management of status epilepticus due to its rapid onset and short duration of action [1].

2. How has COVID-19 affected midazolam demand?
   The pandemic increased ICU sedation requirements, temporarily boosting demand, though supply chain disruptions and regulatory challenges also emerged.

3. Are there safety concerns associated with midazolam?
   Yes; risks include respiratory depression, dependence, and misuse potential. Regulatory bodies have tightened controls to mitigate abuse.

4. What innovations are emerging within midazolam formulations?
   Intranasal sprays, buccal formulations, and ready-to-use injectable preps aim to enhance ease of administration and broaden outpatient use.

5. Which regions are expected to see the highest growth for midazolam?
   The Asia-Pacific region is poised for significant growth owing to expanding healthcare infrastructure and procedural volume.

---

References

[1] Smith, J. et al. (2022). "Clinical Applications of Midazolam in Anesthesia and Critical Care." Journal of Pharmacology.

[2] Lee, A., & Chen, P. (2023). "Market Trends in Sedatives: Focus on Midazolam." Healthcare Business Review.