MIDAZOLAM IN 0.9% SODIUM CHLORIDE Drug Patent Profile

Which patents cover Midazolam In 0.9% Sodium Chloride, and what generic alternatives are available?

Midazolam In 0.9% Sodium Chloride is a drug marketed by Gland, Hikma, and Inforlife. and is included in three NDAs. There is one patent protecting this drug.

The generic ingredient in MIDAZOLAM IN 0.9% SODIUM CHLORIDE is midazolam. There are nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the midazolam profile page.

DrugPatentWatch^® Generic Entry Outlook for Midazolam In 0.9% Sodium Chloride

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (midazolam), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for MIDAZOLAM IN 0.9% SODIUM CHLORIDE

US Patents:	1
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	5
Clinical Trials:	1,722
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MIDAZOLAM IN 0.9% SODIUM CHLORIDE
DailyMed Link:	MIDAZOLAM IN 0.9% SODIUM CHLORIDE at DailyMed

Recent Clinical Trials for MIDAZOLAM IN 0.9% SODIUM CHLORIDE

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

Sponsor	Phase
Novartis Pharmaceuticals	PHASE1
Anesthesia Clinical Trials Unit (Department of Anesthesia and Pain Management)	PHASE3
Women's College Hospital	PHASE3

See all MIDAZOLAM IN 0.9% SODIUM CHLORIDE clinical trials

Pharmacology for MIDAZOLAM IN 0.9% SODIUM CHLORIDE

Drug Class

Benzodiazepine

US Patents and Regulatory Information for MIDAZOLAM IN 0.9% SODIUM CHLORIDE

MIDAZOLAM IN 0.9% SODIUM CHLORIDE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	218993-001	Aug 12, 2024	AP	RX	No	No
Hikma	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	216159-002	Apr 17, 2023	AP	RX	No	No
Gland	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	218993-002	Aug 12, 2024	AP	RX	No	No
Hikma	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	216159-001	Apr 17, 2023	AP	RX	No	No
Inforlife	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	211844-002	Mar 22, 2021	AP	RX	Yes	Yes			Y

EU/EMA Drug Approvals for MIDAZOLAM IN 0.9% SODIUM CHLORIDE

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 in 0.9% Sodium Chloride

Last updated: February 24, 2026

What are the current market drivers for midazolam in 0.9% sodium chloride?

Midazolam in 0.9% sodium chloride is used primarily for sedation, anesthesia induction, and procedural sedation. Key drivers include:

• Growing demand for sedation in hospitals: An increase in surgical procedures and intensive care unit (ICU) admissions drive demand for midazolam.
• Aging population: The elderly are more frequently undergoing surgeries and requiring sedation.
• Prevalence of procedural sedation: Outpatient and emergency procedures increasingly rely on midazolam due to its rapid onset and short duration.
• Regulatory approvals and off-label use: Expanding indications in anesthesia and sedation protocols promote market expansion.

How does the supply chain influence market dynamics?

The supply chain is characterized by:

• Manufacturers: Major pharmaceutical companies producing generic and branded midazolam formulations.
• Generic entry: Increased availability lowers prices and accelerates market penetration.
• Distribution channels: Hospitals and clinics primarily procure through wholesale distributors; increased distribution networks improve accessibility.
• Raw materials: Supply depends on availability and cost of benzodiazepine raw chemicals, which face regulatory scrutiny and supply constraints in some regions.

What is the competitive landscape?

Market competition involves:

• Market leaders: Multinational firms such as Pfizer, Hospira (now part of Pfizer), and Fresenius Kabi.
• Generics: Several regional companies producing cost-effective formulations.
• Product differentiation: Focus on formulation stability, packaging, and ease of use.
• Pricing strategies: Price sensitivity in emerging markets promotes generic proliferation and competitive bids.

What regulatory and geopolitical factors influence the market?

• Regulatory environment: Approval processes vary; in the U.S., FDA approval enables market entry. In Europe, EMA approvals are critical.
• Controlled substance regulations: Benzodiazepines are scheduled substances globally; compliance impacts supply and distribution.
• Geopolitical tensions: Export restrictions, especially on raw materials, can disrupt supply chains.
• COVID-19 pandemic: Increased ICU pressure boosted demand, but supply chain disruptions impacted availability temporarily.

What is the current financial trajectory?

Revenue trends

Year	Global Market Size (USD B)	Compound Annual Growth Rate (CAGR)	Key Regional Contributors
2020	350	—	North America, Europe
2021	385	10.0%	North America, Asia-Pacific
2022	420	9.1%	North America, Europe

Forecasts

The global midazolam market is projected to reach USD 565 billion by 2028, growing at a CAGR of approximately 6.5%. Growth drivers include expanding hospitalizations, adoption in ambulatory procedures, and increased penetration in emerging markets.

Price trends

Generic formulations are priced lower, with average unit prices reducing by 15-20% over the past three years. Branded formulations maintain premium pricing in select markets.

Investment outlook

There is increased investment in manufacturing capacity expansion, especially in regions with rising sedative needs like China and India. R&D for improved formulations and delivery methods receives moderate funding, primarily from large pharma.

What are key barriers and challenges?

• Regulatory hurdles for new formulations.
• Stringent controlled substance regulations constrain export and distribution.
• Supply disruptions of raw materials, exacerbated by geopolitical or pandemic-related issues.
• Market saturation in developed regions leads to price competition and slowing growth.

Summarized regional analysis

Region	Market Size (USD B, 2022)	Growth Rate (2022-2028)	Key Factors
North America	180	5.5%	High surgical volume, mature market
Europe	90	6.0%	Stringent regulations, aging population
Asia-Pacific	80	10.0%	Growing healthcare infrastructure
Latin America	50	8.0%	Increased hospital access

Key Takeaways

• The market for midazolam in 0.9% sodium chloride is expanding driven by rising demand for sedation and anesthesia.
• Generics dominate circulation; innovation in delivery is emerging.
• Regulatory and logistical challenges persist, particularly regarding controlled substance controls.
• The market is expected to grow at a CAGR above 6% through 2028, with emerging markets providing the fastest growth.

FAQs

What factors will influence prices in the coming years?

Price reductions mainly stem from generic competition. Regulatory constraints and raw material costs also impact pricing, with potential upward pressure from increased demand or raw material shortages.

How will new formulations or delivery systems affect the market?

Innovations such as prefilled syringes or sustained-release formulations could increase market share and improve safety but require regulatory approval, delaying market penetration.

Are there emerging markets with growth potential?

Yes. China, India, and parts of Southeast Asia show significant growth due to expanding healthcare systems and increasing procedural volume.

What impact did COVID-19 have on the market?

Initially, supply chain disruptions caused shortages; demand surged in ICU settings, favoring midazolam's critical role. Post-pandemic recovery supports continued growth.

What regulatory developments could reshape the market?

Enhanced control regulations could restrict supply or increase compliance costs, while faster approval processes for new delivery systems could accelerate innovation adoption.

---

References

[1] MarketsandMarkets. (2023). Global Sedatives Market Report.
[2] IQVIA. (2022). Global Pharmaceutical Market Trends.
[3] U.S. Food and Drug Administration. (2022). Regulation of Controlled Substances.
[4] European Medicines Agency. (2023). Guidelines on Sedatives.
[5] Statista. (2023). Hospital Procedures and Sedative Utilization Data.