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 Pharma Ltd, 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. Five 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 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:	3
Clinical Trials:	1,499
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
University of Alabama at Birmingham	Phase 1
Medical University of South Carolina	Phase 4
Ruijin Hospital	Phase 1/Phase 2

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 and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland Pharma Ltd	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 Pharma Ltd	MIDAZOLAM IN 0.9% SODIUM CHLORIDE	midazolam	SOLUTION;INTRAVENOUS	218993-002	Aug 12, 2024	AP	RX	No	No

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/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 IN 0.9% SODIUM CHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Midazolam in 0.9% Sodium Chloride

Market Overview

The market for midazolam, particularly in the formulation of midazolam in 0.9% sodium chloride, is closely tied to the broader pharmaceutical and healthcare sectors. Here are some key dynamics and financial trajectories that shape this market.

Demand Drivers

Medical Need and Applications

Midazolam is a versatile drug with anxiolytic, muscle relaxant, anticonvulsant, sedative, hypnotic, and amnesic properties. Its use in various medical settings, such as procedural sedation, continuous intravenous sedation for intubated and mechanically ventilated patients, and as an adjunct to general anesthesia, drives demand[2][5].

Pharmaceutical-Grade Sodium Chloride

The increasing demand for pharmaceutical-grade sodium chloride, which is a critical component in the formulation of midazolam injections, is a significant driver. This demand is fueled by the need for sterile solutions in medical administration[1][4].

Market Size and Growth

Current Market Size

The sodium chloride market, which includes pharmaceutical-grade sodium chloride used in midazolam formulations, has grown steadily. In 2023, the market size was $27.66 billion, and it is expected to reach $28.98 billion in 2024, with a compound annual growth rate (CAGR) of 4.8%[1][4].

Forecasted Growth

By 2028, the sodium chloride market is projected to grow to $35.33 billion at a CAGR of 5.1%. This growth is supported by increasing demand from the food and pharmaceutical industries, urbanization, and the rising need for processed foods and pharmaceutical-grade sodium chloride[1][4].

Key Trends

Product Innovations

Companies in the sodium chloride and pharmaceutical markets are focusing on developing innovative solutions, such as new formulations of midazolam in 0.9% sodium chloride. For instance, Hikma Pharmaceuticals introduced Midazolam in 0.9% sodium chloride injection in the U.S. market in June 2023, which is a significant addition to their portfolio of generic injectable medicines[1][4].

Strategic Collaborations

Strategic collaborations with end-users, such as hospitals and healthcare providers, are becoming more common. These collaborations help in tailoring products to specific medical needs and improving patient outcomes.

Research and Development

Frequent investments in research and development are a major trend. Companies are engaged in strong R&D efforts to innovate product formulations and meet the evolving medical needs of patients[1][4].

Financial Implications

Revenue Generation

The launch of new products like Midazolam in 0.9% sodium chloride injection can significantly contribute to the revenue of pharmaceutical companies. For example, Hikma Pharmaceuticals' introduction of this product is expected to enhance their revenue streams by providing a crucial option for continuous intravenous sedation[1][4].

Cost-Effectiveness

A cost-effectiveness analysis of midazolam versus other sedatives, such as propofol, shows that midazolam can offer a more economical option for procedural sedation in certain contexts. This can influence healthcare providers' purchasing decisions and impact the financial trajectory of the drug[3].

Market Segmentation

By Grade

The sodium chloride market is segmented by grade, with pharmaceutical-grade sodium chloride being a critical segment for midazolam formulations. This segment is expected to see significant growth due to the increasing demand for sterile and high-quality pharmaceutical products[4].

By Application

The pharmaceutical application segment, which includes the use of sodium chloride in drug formulations like midazolam, is a key driver of market growth. This segment benefits from the rising demand for processed and packaged pharmaceuticals[4].

Regional Markets

Global Expansion

The market for midazolam in 0.9% sodium chloride is not limited to any single region. Companies like Hikma Pharmaceuticals are expanding their reach globally, introducing their products in various markets, including the U.S., Middle East, and Africa[1][4].

Key Takeaways

• Growing Demand: The demand for midazolam in 0.9% sodium chloride is driven by its versatile medical applications and the increasing need for pharmaceutical-grade sodium chloride.
• Innovative Products: New product launches, such as Hikma Pharmaceuticals' Midazolam in 0.9% sodium chloride injection, are driving market growth.
• Financial Growth: The market is expected to grow significantly, with the sodium chloride market reaching $35.33 billion by 2028.
• Cost-Effectiveness: Midazolam can offer a cost-effective option for procedural sedation, influencing purchasing decisions and financial trajectories.

FAQs

What are the primary medical applications of midazolam in 0.9% sodium chloride?

Midazolam in 0.9% sodium chloride is used for procedural sedation, continuous intravenous sedation for intubated and mechanically ventilated patients, and as an adjunct to general anesthesia.

How is the market for sodium chloride impacting the demand for midazolam formulations?

The growing demand for pharmaceutical-grade sodium chloride is driving the demand for midazolam formulations, as sodium chloride is a critical component in these formulations.

What are the key trends in the sodium chloride market that affect midazolam?

Key trends include product innovations, strategic collaborations with end-users, frequent investments in research and development, and innovations in product formulations.

How does the cost-effectiveness of midazolam compare to other sedatives?

Midazolam can be more cost-effective than other sedatives like propofol in certain contexts, making it a preferred option for procedural sedation in some cases.

Which companies are leading the market in midazolam formulations?

Companies like Hikma Pharmaceuticals are leading the market by introducing innovative products such as Midazolam in 0.9% sodium chloride injection.

Sources

1. The Business Research Company: Sodium Chloride Market Size, Share, Trends, Growth And Industry Analysis Report.
2. DrugBank: Midazolam: Uses, Interactions, Mechanism of Action.
3. PubMed: A cost-effectiveness analysis of propofol versus midazolam for procedural sedation in the emergency department.
4. The Business Research Company: Sodium Chloride Global Market Report 2024.
5. FDA: Midazolam Injection, USP - Label.