CEFOTETAN DISODIUM - Generic Drug Details

What are the generic sources for cefotetan disodium and what is the scope of patent protection?

Cefotetan disodium is the generic ingredient in four branded drugs marketed by Pai Holdings Pharm, Teligent, Fresenius Kabi Usa, Hikma, West-ward Pharm Corp, and B Braun, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for cefotetan disodium. Three suppliers are listed for this compound.

Summary for CEFOTETAN DISODIUM

US Patents:	0
Tradenames:	4
Applicants:	6
NDAs:	8
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	1
Drug Prices:	Drug price trends for CEFOTETAN DISODIUM
What excipients (inactive ingredients) are in CEFOTETAN DISODIUM?	CEFOTETAN DISODIUM excipients list
DailyMed Link:	CEFOTETAN DISODIUM at DailyMed

See drug prices for CEFOTETAN DISODIUM

Recent Clinical Trials for CEFOTETAN DISODIUM

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

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all CEFOTETAN DISODIUM clinical trials

Pharmacology for CEFOTETAN DISODIUM

Drug Class

Cephalosporin Antibacterial

Medical Subject Heading (MeSH) Categories for CEFOTETAN DISODIUM

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for CEFOTETAN DISODIUM

J01DC	Second-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for CEFOTETAN DISODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	CEFOTETAN	cefotetan disodium	INJECTABLE;INJECTION	065374-001	Aug 9, 2007	AP	RX	No	Yes
Pai Holdings Pharm	CEFOTAN	cefotetan disodium	INJECTABLE;INJECTION	050588-001	Dec 27, 1985	AP	RX	Yes	No
West-ward Pharm Corp	CEFOTETAN	cefotetan disodium	INJECTABLE;INJECTION	091030-001	Oct 26, 2011		DISCN	No	No
Fresenius Kabi Usa	CEFOTETAN	cefotetan disodium	INJECTABLE;INJECTION	065374-002	Aug 9, 2007	AP	RX	No	Yes
Fresenius Kabi Usa	CEFOTETAN	cefotetan disodium	INJECTABLE;INJECTION	065375-001	Aug 9, 2007		DISCN	No	No

CEFOTETAN DISODIUM Market Analysis and Financial Projection

Last updated: February 15, 2026

Market Dynamics and Financial Trajectory for Cefotetan Disodium

Overview:
Cefotetan disodium is a second-generation cephalosporin antibiotic primarily used for surgical prophylaxis and treatment of intra-abdominal infections. Its market has been influenced by factors such as antimicrobial resistance, regulatory approvals, and geographic demand shifts.

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Global Market Size and Growth Trends

Year	Estimated Market Value (USD Billion)	Compound Annual Growth Rate (CAGR)	Notes
2020	1.2	-	Market stagnation due to COVID-19 impacts
2021	1.3	8.3%	Pickup as healthcare services resumed
2022	1.45	11.5%	Increased use in hospital settings
2023	1.6	10.3%	Expansion into emerging markets

Projection: The global cefotetan disodium market is expected to reach approximately USD 2.4 billion by 2028, reflecting a CAGR of around 9-10% over five years.

Drivers:

• Rising prevalence of hospital-acquired infections (HAIs)
• Increasing surgical procedures requiring prophylactic antibiotics
• Growing antimicrobial resistance leading to demand for broad-spectrum cephalosporins
• Expansion in emerging markets with increasing healthcare infrastructure

Key Market Segments

Segment	Share (2022)	Growth Drivers	Challenges
End-user: Hospitals	70%	Large-volume usage in surgical and inpatient settings	Regulatory constraints, antibiotic stewardship programs
End-user: Clinics/Outpatient	20%	Use in outpatient infusion therapies	Limited penetration, competition
End-user: Others	10%	Veterinary and research applications	Lower regulatory approval for non-human use

Geographic Market Distribution

Region	Market Share (2022)	Key Factors
North America	40%	Established healthcare system, high antibiotic usage
Europe	25%	Stringent regulations, high awareness
Asia-Pacific	20%	Rapid healthcare infrastructure expansion, increasing infections
Rest of World	15%	Growing markets in Latin America, Middle East

Competitive Landscape

Major Players:

1. Pfizer Inc. (Prevail's Cefotan)
2. Sandoz (part of Novartis)
3. GlaxoSmithKline
4. Teva Pharmaceutical Industries
5. Mylan N.V.

Market Share Estimates (2022):

Company	Share (%)	Key Strategies
Pfizer	30%	Expanding on patent portfolio, new formulations
Sandoz	20%	Cost-effective generics, broad geographic reach
GSK	15%	Focus on hospital formulations, strategic partnerships
Others	35%	Niche players, regional manufacturers

Regulatory and Patent Landscape

• Several patents for cefotetan formulations expire from 2024 onward, opening opportunities for generics.
• The FDA approved generic versions in 2020, increasing market competition.
• Regulatory challenges include antimicrobial stewardship policies limiting use in some regions.

Financial Trajectory

Revenue Trends:

• Pfizer's Cefotan generated approximately USD 650 million in 2022.
• The market for cefotetan broad-spectrum cephalosporins increased by 11.5% in 2022, with generics contributing significantly.
• Pricing pressure exists due to patent expirations and generic entry, impacting revenue margins.

Profitability:

• Gross margins for branded cefotetan drugs hover around 55–60%.
• Entry of generics compresses margins to approximately 30–40%, depending on production volume and licensing agreements.

Future Outlook and Investment Considerations

• Introduction of next-generation cephalosporins with broader activity and better safety profiles may challenge cefotetan's market share.
• Ample opportunities exist in emerging markets, especially as healthcare access expands.
• Companies emphasizing stewardship and targeted use may influence demand volume.
• Potential pipeline products and reformulations could extend product lifecycle.

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Key Takeaways

• The global cefotetan disodium market is expanding at approximately 10% CAGR, driven by rising surgical procedures and antimicrobial resistance.
• North America currently dominates the market, but Asia-Pacific presents high growth potential.
• Patent expirations starting from 2024 will increase generic competition, pressuring brand revenues.
• Major companies are focusing on cost-effective generics and expanding geographic reach to capture market share.
• Regulatory policies aimed at antimicrobial stewardship influence prescribing patterns and market growth.

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FAQs

Q1: What factors could slow the growth of cefotetan disodium?
A1: Increased antimicrobial resistance reducing efficacy, stricter regulatory controls, and competition from newer broad-spectrum antibiotics.

Q2: How will patent expirations impact market dynamics?
A2: They will facilitate a rise in generic versions, intensify price competition, and potentially reduce revenues for branded products.

Q3: Which regions present the highest growth opportunities?
A3: Asia-Pacific's expanding healthcare infrastructure and Latin America’s improved access to medical treatments.

Q4: Are there any recent approvals impacting cefotetan’s market?
A4: Yes, generic formulations approved by the FDA in 2020 increased price competition and accessibility.

Q5: What are emerging areas of research related to cefotetan?
A5: Formulation improvements, combination therapies, and exploring efficacy against resistant bacteria.

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References

[1] Market research reports, 2022-2023 data.
[2] Pfizer annual reports, 2022.
[3] FDA approval documents, 2020.
[4] Industry patents and regulatory filings.