CEFTRIAXONE SODIUM - Generic Drug Details

What are the generic drug sources for ceftriaxone sodium and what is the scope of freedom to operate?

Ceftriaxone sodium is the generic ingredient in seven branded drugs marketed by Acs Dobfar, Agila Speclts, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Qilu, Samson Medcl, Sandoz, Sandoz Inc, Teva, Wockhardt, B Braun, Baxter Hlthcare, Anda Repository, Hikma, Hoffmann La Roche, Roche, Astral, Cephazone Pharma, Deva Holding As, Epic Pharma Llc, Hikma Farmaceutica, and Teva Pharms Usa, and is included in forty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-five drug master file entries for ceftriaxone sodium. Seventeen suppliers are listed for this compound.

Summary for CEFTRIAXONE SODIUM

US Patents:	0
Tradenames:	7
Applicants:	26
NDAs:	42
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	23
Patent Applications:	7,388
What excipients (inactive ingredients) are in CEFTRIAXONE SODIUM?	CEFTRIAXONE SODIUM excipients list
DailyMed Link:	CEFTRIAXONE SODIUM at DailyMed

Recent Clinical Trials for CEFTRIAXONE SODIUM

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

Sponsor	Phase
University of Duhok	N/A
Muhammad Junaid Tahir	Phase 3
Ahmad Zia	Phase 3

See all CEFTRIAXONE SODIUM clinical trials

Pharmacology for CEFTRIAXONE SODIUM

Drug Class

Cephalosporin Antibacterial

Medical Subject Heading (MeSH) Categories for CEFTRIAXONE SODIUM

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for CEFTRIAXONE SODIUM

J01DD	Third-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for CEFTRIAXONE SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin	CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INJECTION	065263-001	Sep 12, 2006		DISCN	No	No
Hoffmann La Roche	ROCEPHIN	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	050585-004	Dec 21, 1984		DISCN	Yes	No
Sandoz	CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	065169-002	May 9, 2005	AP	RX	No	Yes

CEFTRIAXONE SODIUM Market Analysis and Financial Projection Experimental

Ceftriaxone Sodium Market Dynamics and Financial Trajectory

Market Overview

Ceftriaxone sodium, a broad-spectrum antibiotic belonging to the cephalosporin class, is widely used to treat various bacterial infections. The market for ceftriaxone sodium is driven by several key factors, including the rising prevalence of infectious diseases and the increasing need for effective antibiotics.

Market Size and Growth Projections

The global ceftriaxone sodium market is anticipated to experience significant growth over the coming years. As of 2024, the market is estimated to be valued at approximately US$ 339.44 million and is forecasted to reach US$ 821.62 million by 2034, growing at a notable CAGR of 9.2% during the projection period[1].

In another projection, the market size was valued at USD 1.8 billion in 2023 and is expected to reach USD 2.37 billion by 2032, growing at a CAGR of 3.09% from 2024 to 2032[3].

Regional Market Analysis

North America

North America is a dominant region in the ceftriaxone sodium market, accounting for approximately 35.6% of the global market share in 2024. This region's strong healthcare system, high prevalence of infectious diseases, and significant healthcare expenditure contribute to its leading position[1]. In 2021, North America held around 44.0% of the global ceftriaxone market, driven by the high incidence rate of bacterial infections and the early adoption of advanced technologies[2].

Western Europe

Western Europe is also a significant market, with a forecasted revenue of US$ 74.88 million in 2024. Countries such as Germany, France, and the United Kingdom are driving this growth due to the increasing use of ceftriaxone sodium to treat serious bacterial infections[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing market during the forecast period. This growth is attributed to the large patient base in countries like India and China, increasing healthcare expenditure, and favorable government initiatives aimed at improving healthcare infrastructure[2][3].

Product Type and Purity

The demand for ceftriaxone sodium with a purity level of > 99.8% is particularly high, accounting for 68.4% of the revenue share in 2024. This high-purity segment is valued for its exceptional qualities, better efficacy, stability, and safety in pharmaceutical formulations[1].

Distribution Channels

Hospital pharmacies are a major distribution channel for ceftriaxone sodium, expected to account for a significant share of the market. Hospitals are preferred for the treatment of bacterial infections due to favorable reimbursement policies and the availability of advanced healthcare facilities[2].

Drivers of Market Growth

• Rising Prevalence of Infectious Diseases: The increasing incidence of bacterial infections such as pneumonia, meningitis, sepsis, and urinary tract infections is a primary driver of the market[1][2].
• Antibiotic Resistance: The effectiveness of ceftriaxone sodium against resistant bacterial strains is another key driver, especially in healthcare settings where stronger medicines are prioritized[1].
• Expiration of Patents: The expiration of patents for blockbuster drugs will enable generic manufacturers to produce ceftriaxone sodium, further driving market growth[1].
• Changing Lifestyles: Lifestyle changes, such as smoking, are making people more susceptible to infections, contributing to the demand for ceftriaxone sodium[1].

Restraints and Challenges

While the market is growing, it faces challenges such as the potential for side effects and the ongoing need to address evolving bacterial resistance patterns. Additionally, regulatory hurdles and the high cost of research and development can act as restraints[2][4].

Key Players and Market Competition

The ceftriaxone sodium market is characterized by the presence of several key players, including multinational pharmaceutical companies and regional manufacturers. Companies like Hikma Pharmaceuticals plc, Qilu Pharmaceutical Co. Ltd., Novartis AG, Baxter International, Inc., and Aurobindo Pharma are competing through product innovation, strategic partnerships, and geographical expansion[2].

Financial Outlook

The financial trajectory of the ceftriaxone sodium market is positive, with significant growth projected over the next decade. The market's expansion is supported by increasing healthcare expenditure, favorable government initiatives, and the growing demand for effective antibiotics.

Illustrative Statistics

• Market Size in 2024: US$ 339.44 million[1]
• Forecasted Market Value in 2034: US$ 821.62 million[1]
• CAGR from 2024 to 2034: 9.2%[1]
• North America Market Share in 2024: 35.6%[1]
• Western Europe Market Value in 2024: US$ 74.88 million[1]
• Asia Pacific Growth Rate from 2024 to 2034: 11.2% CAGR[1]

Key Takeaways

• The ceftriaxone sodium market is driven by the rising prevalence of infectious diseases and the need for effective antibiotics.
• North America and Western Europe are significant markets, while the Asia Pacific region is expected to be the fastest-growing.
• High-purity ceftriaxone sodium (> 99.8%) is in high demand due to its exceptional qualities.
• Hospital pharmacies are a major distribution channel for ceftriaxone sodium.
• The market faces challenges such as antibiotic resistance and regulatory hurdles.

FAQs

Q: What is the current market size of the ceftriaxone sodium market? A: As of 2024, the global ceftriaxone sodium market is estimated to be valued at approximately US$ 339.44 million[1].

Q: What is the forecasted growth rate of the ceftriaxone sodium market from 2024 to 2034? A: The market is forecasted to grow at a CAGR of 9.2% from 2024 to 2034[1].

Q: Which region is expected to be the fastest-growing market for ceftriaxone sodium? A: The Asia Pacific region is expected to be the fastest-growing market during the forecast period, driven by increasing healthcare expenditure and favorable government initiatives[2][3].

Q: What is the significance of high-purity ceftriaxone sodium (> 99.8%) in the market? A: High-purity ceftriaxone sodium (> 99.8%) is in high demand due to its exceptional qualities, better efficacy, stability, and safety in pharmaceutical formulations, accounting for 68.4% of the revenue share in 2024[1].

Q: Which distribution channel is most preferred for ceftriaxone sodium? A: Hospital pharmacies are the most preferred distribution channel for ceftriaxone sodium due to favorable reimbursement policies and the availability of advanced healthcare facilities[2].

Cited Sources:

1. Fact.MR - Ceftriaxone Sodium Market Size, Share & Statistics 2034
2. Transparency Market Research - Ceftriaxone Market Size, Share, and Forecast 2022–2031
3. IntroSpective Market Research - Ceftriaxone Sodium Market - Comprehensive Study Report
4. Market Research Intellect - Ceftriaxone Sodium Sales Market Size, Scope And Forecast Report