DEXTROSE 50% Drug Patent Profile

When do Dextrose 50% patents expire, and what generic alternatives are available?

Dextrose 50% is a drug marketed by Hospira, Intl Medication Sys, Baxter Hlthcare, and Icu Medical Inc. and is included in six NDAs.

The generic ingredient in DEXTROSE 50% is dextrose. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the dextrose profile page.

Summary for DEXTROSE 50%

US Patents:	0
Applicants:	4
NDAs:	6
Finished Product Suppliers / Packagers:	9
DailyMed Link:	DEXTROSE 50% at DailyMed

US Patents and Regulatory Information for DEXTROSE 50%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	DEXTROSE 50%	dextrose	INJECTABLE;INJECTION	019445-001	Jun 3, 1986	AP	RX	Yes	No
Baxter Hlthcare	DEXTROSE 50% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	020047-001	Jul 2, 1991	AP	RX	Yes	Yes
Intl Medication Sys	DEXTROSE 50%	dextrose	INJECTABLE;INJECTION	203451-001	Mar 26, 2021	AP	RX	No	No

Dextrose 50%: Market Dynamics and Financial Trajectory

Introduction to Dextrose 50%

Dextrose, a form of glucose, is a crucial component in medical treatments, particularly for managing conditions like hypoglycemia and providing energy in intravenous solutions. The 50% dextrose injection is a concentrated solution used in emergency medical services and hospital settings.

Market Size and Growth

The global dextrose injection market, which includes the 50% dextrose solution, was valued at US$ 9,512.7 million in 2020 and is expected to grow at a Compound Annual Growth Rate (CAGR) of 5.7% from 2020 to 2027, reaching a projected value of US$ 14,056.6 million by 2027[1].

Key Drivers of Market Growth

Increasing Incidence of Diabetes and Hypoglycemia

The rising number of people with diabetes globally, from 108 million in 1980 to 422 million in 2014, according to the World Health Organization, drives the demand for dextrose injections. Hypoglycemia, a common complication of diabetes treatment, further increases the need for these solutions[1].

Sports and Athletic Use

Athletes use dextrose injections to treat various musculoskeletal issues, contributing to market growth. Initiatives like India's 'Khelo India' program, which promotes sports among individuals with disabilities, also boost demand[1].

Product Launches and Approvals

The market is driven by the launch and approval of new products. For instance, the approval of Clindamycin in dextrose injection (D5W) by the U.S. Food and Drug Administration in 2017 expanded the product portfolio of key players[1].

Market Challenges and Shortages

Current Shortages

The dextrose 50% injection market is facing significant shortages. Manufacturers like Amphastar and Pfizer report shortages due to increased demand and manufacturing delays. These shortages have led to backorders and limited supply, with some products not expected to be restocked until 2025[3][5].

Impact on Emergency Medical Services

The shortage of dextrose solutions has a profound impact on emergency medical services (EMS). According to Stephen Schondelmeyer, PharmD, PhD, "The recent shortages of dextrose are having a far-reaching impact on virtually all firefighters, paramedics, and EMS technicians nationwide." This necessitates the adaptation of emergency kits, revision of treatment protocols, and additional training, all of which add complexity and costs to EMS operations[3].

Regional Market Dynamics

Global Market Share

The global dextrose injection market is segmented by region, with significant shares in North America, Europe, and Asia-Pacific. The Asia-Pacific region dominates the global market, while Europe is the fastest-growing market segment[4].

Key Players and Market Competition

The dextrose injection market is competitive, with key players such as Pfizer Inc., Amphastar Pharmaceuticals Inc., Baxter International Inc., and B Braun Medical Ltd. These companies focus on novel product launches, approvals, and expanding their product portfolios to maintain market presence[1].

Financial Trajectory

Revenue Projections

The global glucose (dextrose) market, which includes the 50% dextrose solution, was valued at USD 47.12 billion in 2022 and is projected to reach USD 71.85 billion by 2031, growing at a CAGR of 4.8% from 2023 to 2031[4].

Cost Implications of Shortages

The shortages of dextrose solutions lead to increased costs for healthcare systems. The need to identify alternative products, revise treatment protocols, and provide additional training adds to the financial burden on EMS and healthcare providers[3].

Regulatory Environment

FDA Approvals and Monitoring

The U.S. Food and Drug Administration (FDA) plays a crucial role in approving new dextrose injection products and monitoring existing ones. The FDA's oversight helps ensure the quality and safety of these critical medical supplies[1][3].

Future Outlook

Addressing Shortages

To mitigate the impact of shortages, manufacturers and healthcare systems must collaborate to ensure a stable supply chain. This includes investing in manufacturing capacity, managing demand more effectively, and identifying reliable alternative sources[3].

Market Expansion

The increasing demand driven by diabetes, hypoglycemia, and athletic use is expected to continue driving market growth. New product launches and approvals will further expand the market, making dextrose injections a vital component of medical care[1].

Key Takeaways

• The global dextrose injection market is valued at US$ 9,512.7 million in 2020 and is expected to grow at a CAGR of 5.7% until 2027.
• The increasing incidence of diabetes and hypoglycemia, along with athletic use, drives market growth.
• Current shortages due to increased demand and manufacturing delays significantly impact EMS operations.
• Key players are focusing on new product launches and approvals to expand their market presence.
• The market is projected to reach USD 71.85 billion by 2031, driven by a CAGR of 4.8%.

FAQs

1. What is the current market size of the global dextrose injection market?

   • The global dextrose injection market was valued at US$ 9,512.7 million in 2020[1].

2. What are the key drivers of the dextrose injection market?

   • The key drivers include the increasing incidence of diabetes and hypoglycemia, athletic use, and new product launches and approvals[1].

3. Why are there shortages of dextrose 50% injections?

   • The shortages are due to increased demand and manufacturing delays reported by manufacturers like Amphastar and Pfizer[3][5].

4. How do shortages of dextrose solutions impact emergency medical services?

   • Shortages lead to the adaptation of emergency kits, revision of treatment protocols, and additional training, adding complexity and costs to EMS operations[3].

5. What is the projected growth rate of the global glucose (dextrose) market?

   • The global glucose (dextrose) market is projected to grow at a CAGR of 4.8% from 2023 to 2031[4].

Sources

1. Coherent Market Insights - Dextrose Injection Market Size, Trends And Forecast To 2027
2. Drugs.com - Ceftriaxone and Dextrose: Package Insert / Prescribing Info
3. CIDRAP - Emergency medical services facing critical dextrose shortage
4. StraitsResearch - Glucose (Dextrose) Market Size, Share and Forecast to 2031
5. ASHP - Drug Shortage Detail: 50% Dextrose Injection