Last Updated: May 3, 2026

cefoxitin sodium - Profile


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

Cefoxitin sodium is the generic ingredient in seven branded drugs marketed by Acs Dobfar, Acs Dobfar Spa, Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Hospira Inc, B Braun, Pharmobedient, Merck, and Samson Medcl, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

Summary for cefoxitin sodium
US Patents:0
Tradenames:7
Applicants:10
NDAs:18

US Patents and Regulatory Information for cefoxitin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acs Dobfar CEFOXITIN cefoxitin sodium INJECTABLE;INJECTION 065414-001 Jun 12, 2009 AP RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Acs Dobfar CEFOXITIN cefoxitin sodium INJECTABLE;INJECTION 065414-002 Jun 12, 2009 AP RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Acs Dobfar CEFOXITIN cefoxitin sodium INJECTABLE;INJECTION 065415-001 May 19, 2010 AP RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Acs Dobfar Spa CEFOXITIN cefoxitin sodium INJECTABLE;INJECTION 065467-001 Aug 31, 2011 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Acs Dobfar Spa CEFOXITIN cefoxitin sodium INJECTABLE;INJECTION 065467-002 Aug 31, 2011 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Cefoxitin Sodium: Investment Scenario and Fundamentals Analysis

Last updated: April 24, 2026

What is cefoxitin sodium and where does it sit in the market?

Cefoxitin sodium is a second-generation injectable cephalosporin antibiotic. It is used in hospital and institutional settings for susceptible bacterial infections, including intra-abdominal and gynecologic infections and related surgical prophylaxis use-cases in many jurisdictions. The drug’s investment profile is shaped by (1) a mature, largely generic market structure, (2) limited innovation upside because cefoxitin is an established molecule with no broad, late-stage “new drug” pipeline attached to it, and (3) regulatory and supply-chain dynamics typical of sterile injectables.

Market reality: For an older, off-patent antibiotic, the economics usually depend more on manufacturing reliability, contracting, pricing discipline, and tender outcomes than on premium pricing or patent-driven exclusivity.

What are the fundamentals that drive value for cefoxitin?

Cefoxitin’s fundamentals are dominated by sterile injectable economics and competitive structure.

Supply and manufacturing: the core variable

  • Sterile manufacturing and batch-release performance drive formulary inclusion and sustained tender wins.
  • Raw material and intermediates availability impacts lead times and cost-of-goods (COGS).
  • Regulatory inspection posture and quality system stability affect continuity of supply.
  • Contracting power: large hospital groups and public procurement frameworks often enforce price ceilings.

Demand characteristics: concentrated, institutional

  • Usage is hospital-centric.
  • Demand is protocol-driven (empiric guidelines, surgical prophylaxis pathways).
  • Purchase cycles align to tender schedules and formulary updates.

Pricing and competition: typically generic-led

  • Cefoxitin is generally sold as a multi-source generic.
  • Price compression is common, and gross margins depend on scale and route optimization (manufacturing efficiency, yield, and fill-finish cost control).

Resistance and stewardship: affects volume, not “brand premium”

  • Antibiotic stewardship programs constrain use to guideline-consistent indications.
  • Resistance trends can shift empiric mix away from certain agents, which impacts volume but usually does not create a patent-like windfall for remaining suppliers.

What does the regulatory status imply for an investment case?

Cefoxitin sodium’s investment profile usually rests on generic-market execution rather than exclusivity.

  • Orphan- or breakthrough-type premium drivers: Not characteristic for an established cephalosporin product line.
  • Exclusivity windows: For a generic, exclusivity is typically limited to data/market exclusivity around specific product approvals, regulatory pathways, or limited-entry arrangements. These are product- and jurisdiction-specific and generally not durable across the molecule.

Investment implication: The dominant risk is operational (quality, supply, cost) and commercial (tender pricing, inventory discipline), not clinical differentiation.

What is the competitive landscape for cefoxitin sodium?

For mature injectable antibiotics, competition typically manifests as:

  • Multiple generic manufacturers offering the same active ingredient and dose forms.
  • Tender- and hospital-contract competition, not physician-driven brand selection.
  • Short-term pharmacy substitution and procurement switching based on delivered price, availability, and rebate structures.

Competitive axes that matter

  • Availability and lead time
  • Cost-to-serve and delivered price
  • Pack size and presentation consistency for hospital procurement
  • Stability and handling fit with pharmacy operations
  • Quality track record (batch failures, recalls, deviations)

What revenue and margin mechanics typically apply?

Cefoxitin sodium is a classic example of an antibiotic where long-term financial outcomes depend on procurement economics.

Revenue drivers

  • Tender wins and conversion rates in hospital systems
  • Penetration into prophylaxis protocols
  • Continuity of supply (avoiding stockouts that permanently reduce contracting trust)

Margin drivers

  • COGS efficiency (API synthesis cost, yields, solvent costs, energy)
  • Sterile fill-finish and logistics cost control
  • Dose standardization and wastage minimization in hospital pharmacy handling
  • Working capital management (inventory turns, shelf-life planning)

Key margin risks

  • Wholesale price declines after more suppliers enter or after procurement re-tendering
  • Recall/quality costs (including lost supply and remanufacturing)
  • Regulatory remediation costs tied to inspection outcomes

How do clinical and use-pattern factors affect volumes?

Cefoxitin’s clinical positioning is well established in hospitals and relies on guideline-consistent prescribing.

Indication behavior (high-level)

  • Intra-abdominal and gynecologic infection coverage for susceptible organisms
  • Surgical prophylaxis where cephalosporins are specified
  • Empiric therapy where local antibiograms support the drug’s spectrum

Stewardship and resistance

  • Antibiotic stewardship reduces unnecessary broad-spectrum use.
  • Shifts in organism prevalence and resistance patterns can alter preferred empiric regimens.

Investment implication: Volume is sensitive to hospital guideline updates and institutional antibiogram interpretations rather than to new clinical trial readouts.

What is the most realistic investment scenario for cefoxitin sodium?

Scenario A: “Execution winner” in a tender-driven generic market

  • Target customers: hospital groups, government procurement, group purchasing organizations.
  • Success conditions:
    • consistent supply
    • competitive delivered pricing
    • low defect rate and strong batch release reliability
    • contract terms that protect against abrupt rebate escalation

Scenario B: Portfolio hedge in an antibiotic basket

  • Use case: an established antibiotic product can stabilize parts of a generic anti-infectives portfolio.
  • Returns are driven by procurement and manufacturing scale rather than molecule-level upside.

Scenario C: Cost-down and manufacturing scale advantage

  • Investment thesis focuses on reducing COGS:
    • higher-yield API process
    • improved intermediate supply contracts
    • sterile fill-finish efficiency
    • reduced wastage and shrink

Bottom line: Without patent-protected premium pricing, the “investment” story is largely about industrial capability and commercial discipline.

What diligence items should investors stress-test?

Even in a mature molecule, diligence determines whether execution can beat market compression.

Quality and regulatory

  • Batch release stability metrics (fail rates, OOS frequency)
  • CAPA history volume and resolution time
  • Sterile manufacturing control robustness (media fill performance, aseptic process controls)
  • Recall history and near-miss rate

Supply chain and economics

  • API and key intermediate qualification status and alternative sourcing
  • Yield, batch size utilization, and cost variance
  • Fill-finish contract reliability (lead times and bottlenecks)
  • Logistics shelf-life and distribution channel constraints

Commercial contracting

  • Historical tender win rate and conversion after re-tenders
  • Contract pricing structure (base, rebate, clawbacks)
  • Allocation policies during shortages

Lifecycle risks

  • Market price erosion cadence after new entrants
  • Hospital guideline updates
  • Switching behavior during supply disruptions

What does the drug’s existence in major compendia imply for adoption?

Cefoxitin appears in authoritative clinical and formulation references used by providers and pharmacists, supporting stable prescribing patterns for susceptible infections and prophylaxis protocols. For example, cefoxitin is listed in drug information compendia and references used for dosing and clinical use guidance. (See citations.) [1-3]

Investment implication: Compendial inclusion supports baseline demand, but it does not protect pricing.

What are the key catalysts and headwinds?

Potential catalysts (commercial/operational)

  • Securing large hospital group tenders in key regions
  • Expanding pack formats aligned to hospital workflows
  • Manufacturing throughput gains that lower COGS
  • Improved supply reliability that shifts contracts from lower-performing suppliers

Key headwinds

  • Ongoing generic price compression
  • Quality incidents in sterile injectables that trigger tender de-selection
  • Antibiotic stewardship and protocol changes that reduce usage share
  • Supply chain disruptions for sterile manufacturing or key inputs

What is the investment stance most consistent with cefoxitin sodium fundamentals?

Cefoxitin sodium fits a generic anti-infectives investment lens:

  • Focus on operational excellence: sterile manufacturing, batch release reliability, and supply continuity.
  • Focus on commercial procurement execution: tender strategy, delivered price management, and rebate discipline.
  • Accept that molecule-level upside is limited: the alpha comes from beating execution benchmarks, not from patent-driven economics.

In most cases, investors underwrite cefoxitin-like antibiotics as cash-generating portfolio assets where returns correlate with execution and scale.


Key Takeaways

  • Cefoxitin sodium is an established second-generation cephalosporin with demand concentrated in hospital/institutional settings and economics dominated by generic pricing and sterile injectable execution.
  • The investment case is driven by manufacturing quality, supply reliability, COGS control, and tender contracting performance, not by molecule-specific exclusivity.
  • Volume is protocol- and stewardship-dependent; pricing is tender-driven with typical generic market compression.
  • The most favorable scenario is an “execution winner” that sustains supply, clears quality hurdles, and maintains competitive delivered pricing through procurement cycles.

FAQs

1) Is cefoxitin sodium a patent-protected product investment?

Cefoxitin sodium’s investment profile is typically aligned with off-patent generic economics rather than patent-driven premium returns.

2) What determines commercial success for cefoxitin in practice?

Tender wins and sustained formulary access driven by consistent supply, reliable batch release, and competitive delivered pricing.

3) How does antibiotic stewardship affect cefoxitin?

Stewardship programs can reduce non-guideline use, limiting volume growth and shifting prescribing toward guideline-consistent use.

4) What are the highest operational risks?

Sterile manufacturing failures (OOS/OOT), aseptic process deviations, recall events, and supply chain disruptions that can lead to permanent contract loss.

5) Where can margin improvement come from?

COGS reduction via higher manufacturing efficiency, better yields, improved fill-finish utilization, and inventory and shelf-life planning that minimizes wastage.


References

[1] United States Pharmacopeia. (n.d.). Cefoxitin sodium (USP listings and monographs).
[2] AHFS Drug Information. (n.d.). Cefoxitin drug information. American Society of Health-System Pharmacists.
[3] Micromedex. (n.d.). Cefoxitin clinical pharmacology and dosing. IBM Micromedex.

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