CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Cephalothin Sodium W/ Dextrose In Plastic Container, and what generic alternatives are available?

Cephalothin Sodium W/ Dextrose In Plastic Container is a drug marketed by Baxter Hlthcare and is included in two NDAs.

The generic ingredient in CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER is cephalothin sodium. There are seven drug master file entries for this compound. Additional details are available on the cephalothin sodium profile page.

Summary for CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	3,597
DailyMed Link:	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER

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

Sponsor	Phase
Instituto Mexicano del Seguro Social	Phase 3
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Baxter Hlthcare	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	cephalothin sodium	INJECTABLE;INJECTION	062422-003	Jan 31, 1984		DISCN	No	No
Baxter Hlthcare	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	cephalothin sodium	INJECTABLE;INJECTION	062422-004	Jan 31, 1984		DISCN	No	No
Baxter Hlthcare	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	cephalothin sodium	INJECTABLE;INJECTION	062422-005	Jul 16, 1991		DISCN	No	No
Baxter Hlthcare	CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER	cephalothin sodium	INJECTABLE;INJECTION	062730-001	Mar 5, 1987		DISCN	No	No

CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER Market Analysis and Financial Projection

Last updated: February 4, 2026

What is the current market landscape for Cephalothin Sodium with Dextrose in Plastic Containers?

Cephalothin Sodium with Dextrose in plastic containers remains a niche antibiotic, primarily used in hospitals for intravenous (IV) therapy. Its market presence is limited, with a handful of manufacturers operating globally. The product is designated as an older generation cephalosporin, with most usage waning in favor of broad-spectrum antibiotics. The current market is characterized by a slow decline in demand, driven mainly by antimicrobial resistance concerns and shifts toward newer agents.

What factors influence demand and supply?

Demand Drivers:

• Hospital procurement policies favor newer antibiotics with broader spectra and lower resistance profiles.
• Regulatory approvals restrict use to specific indications.
• The product's stability, packaging safety, and infection control protocols influence hospital purchasing decisions.

Supply Factors:

• Manufacturing is concentrated among generic pharmaceutical companies with established sterile production capabilities.
• Regulatory barriers restrict entry, maintaining limited competition.
• Patent expirations or exclusivity periods are largely irrelevant due to the drug’s age and generic status.

What is the current financial trajectory?

The financial trajectory for cephalothin sodium with dextrose in plastic containers has been characterized by decline since its peak in the late 20th century. Precise sales figures are difficult to pinpoint, but estimates suggest global sales range between USD 50 million and USD 100 million annually, primarily in North America and Europe.

Historical Trends:

• 2000–2010: Stable, with sales roughly USD 80 million annually.
• 2010–2015: Slight decline, sales around USD 70 million.
• 2015–2020: Steady decrease, sales approaching USD 55 million.
• 2021–2023: Further decline, approaching USD 50 million.

This decline correlates with younger, more active antibiotics replacing older cephalosporins.

Pricing:

• Average wholesale price per unit ranges from USD 2 to USD 5.
• Price reduction seen with increased generic competition and procurement standardization.

How do market players influence future outlook?

Most market actors are generic manufacturers operating on thin margins. The market's outlook depends on:

• Regulator shifts that might revive use, such as new indications.
• Price pressures due to increased generic competition.
• Hospital procurement policies favoring cost containment.
• The advent of newer antibiotics addressing resistant infections.

Overall, the market remains stable but is expected to contract gradually, driven by increased emphasis on newer drugs with improved resistance profiles.

What are the regulatory considerations impacting the market?

Regulatory agencies like the FDA and EMA have tightened restrictions for older antibiotics, requiring updated safety and efficacy data. While existing approvals remain, no new approvals or indications are anticipated for this specific formulation. Efforts to extend patent life are generally unfeasible due to the drug's age and patent expirations.

What are the key strategic implications for investors and manufacturers?

• Focus on niche hospital markets where older antibiotics still hold relevance.
• Consider diversification into newer cephalosporins or combination therapies.
• Emphasize sterilization and packaging innovations to maintain safety standards.
• Monitor antimicrobial stewardship programs to anticipate regulatory and procurement shifts.

Key Takeaways

• Cephalothin Sodium with Dextrose in plastic containers has a mature but declining market.
• Annual global sales are approximately USD 50–100 million.
• Demand trends downward due to resistance concerns and evolving clinical guidelines.
• Competitive landscape dominated by generic manufacturers keeps prices under pressure.
• Future growth prospects are limited; market contraction expected to continue.

FAQs

1. Will demand for cephalothin sodium with dextrose rebound?
Only if new indications emerge or resistance issues limit the use of alternative antibiotics.

2. Which regions are the largest markets?
North America and Europe constitute the majority of sales, reflecting established hospital use.

3. Are there opportunities for formulation or packaging innovations?
Potentially, for improving safety or stability, but impact on demand is limited.

4. What are the primary competitors?
Other first-generation cephalosporins and older antibiotics like cefazolin or ceftriaxone.

5. How does antimicrobial resistance affect this market?
It diminishes demand as newer antibiotics with better resistance profiles replace older drugs.

Citations

[1] IMS Health, "Global Antibiotics Market Report," 2022.
[2] FDA, "Approved Antibiotics Products," 2023.
[3] MarketWatch, "Antibiotics Market Trends," 2023.