MIDOZALAM HYDROCHLORIDE Drug Patent Profile

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When do Midozalam Hydrochloride patents expire, and what generic alternatives are available?

Midozalam Hydrochloride is a drug marketed by Onesource Specialty and is included in one NDA.

The generic ingredient in MIDOZALAM HYDROCHLORIDE is midazolam hydrochloride. There is one drug master file entry for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Midozalam Hydrochloride

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

Summary for MIDOZALAM HYDROCHLORIDE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Patent Applications:	1,900
DailyMed Link:	MIDOZALAM HYDROCHLORIDE at DailyMed

Pharmacology for MIDOZALAM HYDROCHLORIDE

Drug Class

Benzodiazepine

US Patents and Regulatory Information for MIDOZALAM HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Onesource Specialty	MIDOZALAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	090316-001	May 4, 2011	AP	RX	No	No
Onesource Specialty	MIDOZALAM HYDROCHLORIDE	midazolam hydrochloride	INJECTABLE;INJECTION	090316-002	May 4, 2011	AP	RX	No	No

Midazolam Hydrochloride Market Dynamics, Patent Status, Competition, and Financial Trajectory

Last updated: July 31, 2026

Midazolam hydrochloride is a mature, off-patent benzodiazepine used for procedural sedation, anesthesia induction, intensive-care sedation, and seizure treatment. Its commercial market is driven by hospital volume, injectable supply reliability, government procurement, and manufacturing cost rather than exclusivity. U.S. revenue is fragmented among generic manufacturers, and major producers generally do not report midazolam sales separately. Patent barriers are minimal, biosimilar risk is irrelevant, and future growth depends on procedure volumes, hospital purchasing, shortages, and expansion in emerging markets.

What is midazolam hydrochloride and how is it used?

Midazolam hydrochloride is the water-soluble hydrochloride salt of midazolam, a short-acting benzodiazepine. It is marketed primarily as an injectable solution, with oral and intranasal dosage forms also available in some markets.

Attribute	Midazolam hydrochloride
Drug class	Benzodiazepine
Primary mechanisms	GABA-A receptor positive allosteric modulation
U.S. brand	Versed
Main dosage forms	Injectable solution, oral syrup, intranasal products in selected markets
Principal uses	Procedural sedation, anesthesia, ICU sedation, seizure control
Controlled-substance status	U.S. Schedule IV
Reference U.S. approval	Versed injection, FDA-approved in the 1980s
Biosimilar pathway	Not applicable
Current market structure	Generic and institutional purchasing market

Midazolam has a rapid onset and relatively short duration compared with many older benzodiazepines. Hospitals use it in endoscopy, emergency medicine, interventional radiology, surgery, dentistry, intensive care, and pediatric procedures. Its injectable form is the largest commercial segment in institutional care.

The product is typically supplied in concentrations including 1 mg/mL and 5 mg/mL. Common presentations include single-dose vials, ampules, and ready-to-use or pharmacy-prepared formats. Product availability varies by manufacturer and country.

When did midazolam hydrochloride lose exclusivity?

Midazolam hydrochloride lost meaningful U.S. market exclusivity decades ago. The original Versed product was introduced in the 1980s, and generic injectable products have competed for many years.

The relevant commercial conclusion is direct: midazolam hydrochloride is a mature generic medicine with no remaining originator exclusivity that controls routine hospital use.

Exclusivity category	Current position
New chemical entity exclusivity	Expired
Original product patent protection	Expired
U.S. generic competition	Established
Pediatric exclusivity	No current commercial significance
Orphan exclusivity	Not the basis of the principal market
Biosimilar exclusivity	Not applicable
Current market barrier	Manufacturing, quality, supply, contracting, and regulatory compliance

The original brand, Versed, does not control the market in the way that a recently approved small-molecule product would. Hospitals generally purchase generic midazolam through group purchasing organizations, distributors, direct contracts, or government tenders.

What patents protect midazolam hydrochloride?

No active composition-of-matter patent is commercially relevant to standard midazolam hydrochloride supply in the United States. The core molecule, its hydrochloride salt, and conventional injectable use are long-established.

What formulation patents cover midazolam?

Formulation and delivery patents can arise around specific products rather than the active ingredient itself. Potentially relevant areas include:

• Intranasal delivery systems
• Buccal or transmucosal formulations
• Pediatric dosing systems
• Ready-to-administer presentations
• Stabilization and packaging
• Device-based delivery
• Combination products for seizure rescue

These rights do not generally create a barrier to conventional midazolam hydrochloride injection. A company commercializing an intranasal product may have a more defensible formulation and device position than a supplier selling standard injectable vials.

The strongest modern intellectual-property positions are associated with differentiated delivery products rather than the basic injectable salt. For example, branded seizure-rescue products may rely on device, formulation, method-of-use, or combination claims. Those rights are product-specific and should not be treated as blocking patents against generic midazolam injection.

What method-of-use patents cover midazolam?

Method-of-use patents may cover specific clinical settings, administration routes, dosing schedules, or patient populations. Their commercial value is limited when the drug is already widely used off patent and treatment protocols are difficult to police.

A method-of-use patent could affect a branded rescue product or a narrow indication. It does not normally prevent hospitals from purchasing generic midazolam for anesthesia or procedural sedation.

What is the Orange Book status of midazolam hydrochloride?

The U.S. Orange Book lists approved drug products and patent information submitted by sponsors. Midazolam injection is an established generic category with multiple approved abbreviated new drug applications. The core injectable market is not protected by a live originator patent estate that prevents generic substitution.

Relevant regulatory records include:

• FDA Orange Book listings for midazolam injection and other approved dosage forms
• FDA Drugs@FDA records for Versed and related products
• FDA-approved generic labels
• National Drug Code listings for individual suppliers

Orange Book status must be assessed at the product level because patents can attach to a specific formulation, device, or method of use. A generic vial of midazolam hydrochloride should be evaluated separately from branded nasal or rescue products.

Are there Paragraph IV challenges to midazolam hydrochloride?

Paragraph IV litigation is not a central market issue for standard midazolam hydrochloride injection. The product has been generic for many years, and the main commercial competition is among approved suppliers rather than between a single originator and a new generic entrant.

A Paragraph IV filing can still arise for a newer midazolam formulation, delivery system, or combination product. That scenario differs from the established injectable market:

Product type	Paragraph IV relevance
Conventional injectable midazolam	Low
Oral syrup	Low
Intranasal rescue product	Potentially material
Device-enabled rescue product	Potentially material
New combination or pediatric delivery system	Product-specific

The absence of meaningful current Paragraph IV activity for the conventional injection reflects the age of the molecule and the depth of generic competition.

Which companies compete in the midazolam hydrochloride market?

The U.S. injectable market includes generic manufacturers and branded hospital suppliers. Companies with midazolam products or historical participation have included Pfizer and Hospira, Hikma Pharmaceuticals, Fresenius Kabi, Sagent Pharmaceuticals, and other regional suppliers. Availability changes as manufacturers discontinue presentations, transfer approvals, or adjust production.

Competition is based on:

1. Approved manufacturing capacity
2. Sterile injectable reliability
3. Contract pricing
4. Vial and concentration availability
5. Regulatory inspection history
6. Distribution coverage
7. Shortage performance
8. Hospital formulary acceptance

The supplier landscape is more concentrated than the number of product labels suggests. Sterile injectables require specialized facilities, validated aseptic processes, container-closure controls, and reliable active pharmaceutical ingredient supply. Those requirements create operational barriers even when patent barriers are absent.

How does midazolam compare with competing sedatives?

Drug	Main competitive role	Commercial position
Midazolam	Short procedural sedation and seizure rescue	Mature generic, broad institutional use
Lorazepam	Anxiety, seizures, ICU and emergency use	Generic, longer duration
Diazepam	Seizures, muscle spasm, anxiety	Generic, broader legacy use
Propofol	Anesthesia and deep sedation	High-volume injectable competitor
Dexmedetomidine	ICU and procedural sedation	Differentiated hospital product, historically higher pricing
Ketamine	Anesthesia, analgesia, sedation	Generic, distinct pharmacology
Etomidate	Induction of anesthesia	Niche injectable
Remimazolam	Procedural sedation and anesthesia	Newer branded or limited-competition category in some markets

Midazolam retains demand because of its speed, familiarity, broad clinical use, and low generic acquisition cost. Propofol competes strongly in anesthesia and deep sedation. Dexmedetomidine competes in ICU sedation, where its clinical profile and monitoring requirements differ. Remimazolam can compete in procedural sedation and anesthesia but has not displaced the established generic market.

What is the FDA regulatory status of midazolam hydrochloride?

Midazolam hydrochloride is FDA-approved in several dosage forms and indications. The injectable product is labeled for:

• Preoperative sedation and relief of anxiety
• Sedation before diagnostic or therapeutic procedures
• Induction of general anesthesia
• Continuous infusion for ICU sedation in selected settings

The FDA label includes boxed warnings concerning respiratory depression, respiratory arrest, airway obstruction, and the need for appropriate monitoring and resuscitation capability. These warnings affect hospital protocols and purchasing decisions but do not materially reduce the drug’s entrenched use.

Midazolam is a controlled substance under the federal Controlled Substances Act. DEA Schedule IV status creates compliance obligations for manufacturing, distribution, inventory, recordkeeping, and dispensing. It is a regulatory burden, not a market-exclusivity mechanism.

What supply-chain risks affect midazolam hydrochloride?

The main supply risk is sterile injectable manufacturing. Shortages can result from:

• Facility shutdowns or remediation
• Quality-control failures
• Component shortages
• Active ingredient constraints
• Manufacturing prioritization
• Demand spikes during respiratory outbreaks or mass-casualty events
• Limited capacity for specific vial sizes or concentrations

The FDA Drug Shortages database has recorded periods in which injectable midazolam availability was constrained. Hospital buyers often respond by qualifying multiple suppliers, adjusting concentration preferences, and using alternative sedatives.

Supply disruptions can temporarily improve manufacturer pricing, but they do not create durable pricing power unless a supplier controls a scarce presentation or has limited competition. Once supply normalizes, institutional purchasing pressure generally returns.

How strong is the patent estate for midazolam hydrochloride?

The patent estate is weak for conventional midazolam hydrochloride injection and stronger only for selected delivery innovations.

Patent factor	Assessment
Core molecule	Expired
Hydrochloride salt	No meaningful current blocking position
Standard injectable formulation	Weak patent protection
Intranasal delivery	Potentially stronger, product-specific
Device integration	Potentially stronger
New rescue indication	Narrow method-of-use value
Manufacturing know-how	Commercially relevant but difficult to value publicly
Regulatory exclusivity	Limited for established generic products

Manufacturing know-how can still provide a competitive advantage. Sterile injectable production depends on process validation, environmental controls, fill-finish expertise, container compatibility, and consistent batch release. These capabilities are not equivalent to patent exclusivity, but they can limit the number of dependable suppliers.

What generic launch risks exist for midazolam hydrochloride?

For standard injectable midazolam, generic launch risk is low from an intellectual-property perspective and moderate from an execution perspective.

A new entrant must manage:

• ANDA approval and bioequivalence requirements
• Controlled-substance registration
• Sterile manufacturing validation
• Commercial-scale fill-finish capacity
• Approved vial configurations
• FDA inspection readiness
• Distributor and group-purchasing contracts
• Low-margin pricing
• Potential shortage-driven demand volatility

The principal risk is that additional approval does not translate into sustainable share. Mature injectable markets can have low net prices and high customer concentration. Hospitals may keep a supplier as a secondary source rather than switch their primary contract.

What would a generic launch scenario look like?

Scenario	Likely market effect
New supplier enters during normal supply	Price pressure and limited share capture
New supplier enters during shortage	Faster adoption and stronger contracting opportunity
Supplier adds an unavailable concentration	Higher probability of hospital uptake
Supplier offers ready-to-use format	Potential premium versus standard vials
Supplier has a quality event	Rapid loss of share and regulatory exposure
Brand launches differentiated delivery product	Segmented competition, not direct replacement of all injection volume

What is the financial trajectory for midazolam hydrochloride?

Midazolam hydrochloride has a mature, low-growth financial profile in standard injectable form. Revenue is distributed across many suppliers, and public companies generally combine midazolam sales with broader injectable, hospital, or generic portfolios.

Revenue drivers

The market’s financial trajectory is shaped by:

• Procedure volumes
• Hospital admissions
• Endoscopy and ambulatory surgery activity
• ICU utilization
• Seizure-rescue demand
• Generic price erosion
• Shortage-related price increases
• Geographic expansion
• Product mix by concentration and presentation
• Branded delivery-system innovation

Base demand is relatively stable because midazolam is embedded in hospital protocols. Revenue growth from unit expansion is usually modest. Price increases can occur during shortages, but generic competition limits the durability of those gains.

Margin profile

Standard injectable midazolam is generally a low- to moderate-margin generic product. Gross margins depend on:

• Active ingredient cost
• Sterile fill-finish utilization
• Packaging and container costs
• Contract price
• Government tender exposure
• Freight and inventory requirements
• Quality remediation costs

A supplier with underutilized sterile capacity may accept aggressive pricing to improve facility utilization. A supplier with scarce capacity or a shortage-available presentation may achieve better pricing.

Branded rescue products create a separate financial segment

Intranasal and other user-friendly rescue formulations can support materially higher prices than conventional injectable midazolam. Their economics depend on:

• Device ownership
• Formulation patents
• Pediatric and caregiver usability
• Emergency medical positioning
• Reimbursement
• Pharmacy distribution
• Competing diazepam and other seizure-rescue products

This segment is commercially distinct from hospital injection sales. A branded nasal product can generate higher revenue per dose but faces reimbursement, formulary, patient-access, and patent risks that do not apply to a basic generic vial.

What licensing deals affect midazolam hydrochloride?

Licensing activity is more likely in differentiated delivery systems than in standard injectable midazolam. Potential deal structures include:

• Regional rights for intranasal products
• Technology licenses for drug-device systems
• Contract manufacturing agreements
• Distribution partnerships
• Co-development of pediatric rescue products
• In-licensing of seizure-treatment formulations

The conventional injectable market generally does not require a licensing strategy because manufacturers can rely on established active ingredient and formulation technology. Commercial partnerships are more relevant where a company lacks sterile capacity, a delivery device, regulatory infrastructure, or regional distribution.

What patent litigation affects midazolam hydrochloride?

There is no central, ongoing patent dispute that defines the conventional U.S. midazolam hydrochloride injection market. Litigation exposure is more likely to arise from:

• Branded intranasal products
• Device patents
• Formulation patents
• Method-of-use claims
• ANDA litigation involving a newer product
• Product liability claims related to respiratory depression or administration errors

Patent litigation involving a branded midazolam delivery product should not be generalized to the established injectable market. The legal and commercial risk profiles are different.

What geographic markets offer growth potential?

North America and Western Europe are mature markets with stable institutional demand and strong generic price competition. Growth opportunities are more likely in:

• Asia-Pacific hospital systems
• Latin American surgical markets
• Middle Eastern healthcare expansion
• Private hospitals in emerging economies
• Ambulance and emergency-care networks
• Pediatric and seizure-rescue channels

Geographic expansion requires compliance with local controlled-substance rules, registration requirements, tender systems, pharmacopoeial standards, and import controls. In many markets, the competitive advantage is dependable supply rather than patent ownership.

What is the generic and commercial outlook for midazolam hydrochloride?

The commercial outlook is stable for standard injectable use and more attractive for differentiated delivery products.

Period	Expected market direction
Near term	Stable hospital demand, periodic shortage-driven volatility
Medium term	Continued generic price pressure and supplier consolidation
Longer term	Limited growth in injection volume; selective expansion in rescue delivery systems
Patent risk	Low for conventional injection
Regulatory risk	Moderate because of controlled-substance and sterile-manufacturing requirements
Financial upside	Limited for commodity injection; higher for branded delivery platforms

The strongest investment case is not a new patent on the old molecule. It is a reliable sterile manufacturing platform, a differentiated delivery system, or a product that solves access and administration problems in seizure rescue and procedural care.

Key Takeaways

• Midazolam hydrochloride is a mature, off-patent benzodiazepine with extensive generic competition.
• The conventional injectable market has no meaningful originator exclusivity.
• Paragraph IV risk is low for standard injection but can matter for newer nasal, device-enabled, or combination products.
• No biosimilar pathway applies because midazolam is a small-molecule drug.
• Sterile manufacturing capacity, FDA compliance, and supply reliability are more important than patents.
• Hospital demand is stable, while generic price erosion limits long-term revenue growth.
• Intranasal and other differentiated delivery systems offer greater pricing potential than standard vials.
• Public manufacturers generally do not disclose standalone midazolam revenue.
• Shortages can temporarily improve pricing and market share for reliable suppliers.
• The market’s long-term financial profile is stable for injection and selectively growth-oriented for proprietary rescue formulations.

FAQs About Midazolam Hydrochloride Market and Patent Risk

Is midazolam hydrochloride still under patent?

The core midazolam hydrochloride molecule and conventional injectable formulation are not under commercially meaningful U.S. patent exclusivity. Product-specific patents may apply to newer delivery systems.

Can a generic company launch midazolam injection without a license from the original manufacturer?

Yes. Approved generic manufacturers can market standard midazolam injection without licensing the original Versed manufacturer, subject to FDA approval, controlled-substance compliance, and manufacturing requirements.

Is midazolam hydrochloride a biologic or biosimilar product?

No. Midazolam hydrochloride is a chemically synthesized small-molecule drug. Generic-drug rules apply rather than the FDA biosimilar pathway.

Why can midazolam prices rise despite expired patents?

Prices can increase during sterile-injectable shortages, supplier withdrawals, production interruptions, or demand spikes. Those increases reflect supply conditions rather than patent protection.

Which midazolam products have the highest commercial differentiation?

Intranasal, buccal, pediatric, and device-enabled rescue products have greater differentiation than standard injectable vials. Their value depends on delivery convenience, clinical setting, reimbursement, and any surviving formulation or device rights.

References

1. U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book

3. U.S. Food and Drug Administration. (2024). Midazolam injection prescribing information. FDA-approved product labeling.

4. U.S. Food and Drug Administration. (2024). Drug shortages database. https://www.accessdata.fda.gov/scripts/drugshortages/

5. U.S. Drug Enforcement Administration. (2024). Drug scheduling. https://www.dea.gov/drug-information/drug-scheduling

6. U.S. Food and Drug Administration. (2024). National Drug Code directory. https://www.accessdata.fda.gov/scripts/cder/ndc/