Last Updated: June 18, 2026

CEPHALOTHIN Drug Patent Profile


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Summary for CEPHALOTHIN
Recent Clinical Trials for CEPHALOTHIN

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SponsorPhase
Instituto Mexicano del Seguro SocialPhase 3
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

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US Patents and Regulatory Information for CEPHALOTHIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intl Medication CEPHALOTHIN cephalothin sodium INJECTABLE;INJECTION 062426-002 May 3, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER cephalothin sodium INJECTABLE;INJECTION 062422-006 Jul 16, 1991 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Abbott CEPHALOTHIN SODIUM cephalothin sodium INJECTABLE;INJECTION 062547-002 Sep 11, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Intl Medication CEPHALOTHIN cephalothin sodium INJECTABLE;INJECTION 062426-001 May 3, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol CEPHALOTHIN SODIUM cephalothin sodium INJECTABLE;INJECTION 062464-002 May 7, 1984 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
Last updated: June 6, 2026

Cephalosporin Antibiotic Cephalothin Market Dynamics and Financial Trajectory: US Uptake, Price Erosion, and Competitive Pressure

Cephalothin (an older first-generation cephalosporin) has largely transitioned from a hospital-first branded antibiotic to a low-price, highly genericized product with limited commercial expansion. Market dynamics are driven by (1) sustained generic availability, (2) constrained clinical use versus broader-spectrum alternatives, (3) periodic shortages and supply disruptions typical of mature sterile injectables, and (4) procurement-led price compression in US institutional channels. Financial trajectory trends toward declining and volatile revenue with high sensitivity to supply continuity and contract pricing.

What is the current market for cephalothin (US) and who buys it?

Cephalothin is used primarily in inpatient and procedural settings where clinicians select narrow-spectrum beta-lactams aligned with susceptibility patterns, historical stewardship pathways, and formulary protocols. In the US, buying is dominated by hospital pharmacy and group purchasing organization (GPO) contract channels.

Hospital procurement dynamics

  • Primary channel: Institutional purchasing (IDNs, hospitals, ambulatory surgery centers that stock injectable antibiotics).
  • Buyer constraints: Sterile injectable availability, lot reliability, and contract pricing terms outweigh brand differentiation.
  • Clinical drivers: Use is generally narrower than later cephalosporins and carbapenems, limiting volumetric growth potential.

Competitive substitution risk

Cephalothin faces substitution pressure from:

  • Other first-generation cephalosporins with easier sourcing or preferred formulary status (within the class).
  • Broader-spectrum beta-lactams where local antibiogram and guideline frameworks favor escalation.

How has cephalothin pricing evolved as generics took over?

Cephalothin’s mature status creates a market structure characterized by:

  • Multiple generic SKUs competing on acquisition cost.
  • Contract pricing pressure from GPO negotiations.
  • Occasional price spikes during supply constraints that do not translate into durable margins once supply normalizes.

Pricing mechanics for mature sterile injectables

  • Tender cycles drive rapid resets of net price.
  • Manufacturer allocation during shortages can lift average selling prices temporarily, but only while demand exceeds supply.
  • Portfolio shrinkage risk: when manufacturers exit or reduce production due to compliance or profitability, price volatility increases.

What does cephalothin’s financial trajectory look like for brand versus generics?

Cephalothin’s commercial profile is consistent with a “late-life” sterile generic:

  • Brand revenue exposure: Historically dominant branded sales have been compressed as generic entrants normalized.
  • Generic economics: Lower margins, reliance on volume, and high sensitivity to manufacturing uptime and regulatory compliance.
  • Net trajectory: Typically downward over time for legacy branded products, with generic revenue split among suppliers and intermittent volatility tied to supply.

Typical revenue pattern for this product class

  • Early stage: Higher branded share and less price competition.
  • Mid-to-late life: Multiple generic entries and steady erosion of net price.
  • Later life: Concentration into fewer qualified suppliers, with periodic disruption-driven swings in revenue.

What regulatory and exclusivity events influence cephalothin demand and supply?

Because cephalothin is an older drug with a long commercial history, demand is less influenced by “new exclusivity” and more influenced by:

  • Manufacturing status and sterility assurance system stability.
  • FDA quality and facility compliance that can remove supply unexpectedly.
  • Procurement rules that lock in awarded suppliers for contract cycles.

Sterile injectable compliance impact

For injectable antibiotics, facility issues and validation slippage can cause:

  • Temporary withdrawal or limited distribution.
  • Increased lead times.
  • Allocation that reverberates across hospital formulary distribution.

How many companies sell cephalothin and what does that mean for market power?

The market structure typically supports:

  • Fragmented supply early, then partial consolidation as some manufacturers reduce investment.
  • Lower bargaining power for any single supplier, except during supply shortage periods.

Supply concentration and pricing volatility

When the supply base narrows:

  • Contract prices can rise quickly.
  • Hospitals may switch to alternative antibiotics, reducing retention of elevated pricing after normalization.

What competitive threats does cephalothin face from other antibiotics?

Cephalothin’s primary competitive threats are clinical substitution risks:

  • Broader-spectrum cephalosporins and beta-lactam/beta-lactamase inhibitor combinations that align with evolving inpatient infection treatment patterns.
  • Stewardship-driven selection: clinicians increasingly prefer regimens that match local resistance patterns and minimize unnecessary exposure.

Substitution impact on volume

  • Even if cephalothin remains on formularies, its share can decline when protocols favor alternatives.
  • During shortage windows, cephalothin demand may spike, but sustained gains are limited once supply improves elsewhere.

What generic entry risks exist for cephalothin and do they affect near-term revenue?

Generic entry risk for cephalothin is generally low in the near term because the molecule is mature and broadly available. The more relevant “entry” or “risk” factor is:

  • Supplier removal and re-entry due to manufacturing and regulatory constraints.

Practical risk for forecasting

  • Revenue volatility often comes from availability rather than new competitive entrants.
  • Forecast accuracy depends more on supply reliability than on competitive product launches.

When does cephalothin lose exclusivity or patents, and does that matter now?

For a drug of this age, the exclusivity and patent landscape is typically no longer a key driver of market dynamics in the US. Commercial outcomes are instead tied to:

  • Current supplier set.
  • Contract pricing mechanics.
  • Sterile injectable production continuity.

How does cephalothin compare with other first-generation cephalosporins commercially?

Cephalothin competes indirectly with other first-generation cephalosporins that may offer:

  • Better formulary positioning.
  • More stable supply.
  • Lower acquisition cost at tender time.

Commercial comparison vectors

  • Net price: driven by generic competition and contract rebates.
  • Availability: lot-level reliability is often the determining factor for hospital substitution.
  • Formulation and packaging: changes in vial size, labeling, or stability can affect purchasing decisions.

What financial outcomes are typical during cephalothin shortages?

During supply constraints:

  • Average selling prices can temporarily improve.
  • Revenue can rise due to allocation-driven replenishment.
  • Profit is still constrained by costs of expedited procurement, higher working capital needs, and compliance-driven manufacturing adjustments.

After shortages normalize

  • Revenue typically falls as hospitals revert to contracted suppliers and alternative therapies restore availability.
  • Price erosion resumes under competitive procurement rules.

Which jurisdictions matter most for cephalothin’s financial trajectory?

The most material financial influence for a mature US antibiotic usually comes from:

  • United States institutional demand and procurement.
  • Secondary markets may matter, but US hospital contracting often drives the dominant commercial baseline.

What patent estate issues affect cephalothin manufacturers or challengers?

For an older antibiotic, patent estate issues are generally not the primary driver of near-term market dynamics. The economic drivers are:

  • Whether manufacturing sites remain compliant and operational.
  • Whether customers keep it on contract.
  • Whether shortages drive temporary price recoveries.

What licensing or litigation activity is likely to shape the market?

Cephalothin’s mature status makes active, high-impact litigation less central to market outcomes than for newer specialty products. Market shaping more commonly occurs through:

  • Manufacturer entry or exit tied to profitability and compliance.
  • Supply continuity events.

What is the commercial bottom line for investors and strategists considering cephalothin?

Cephalothin fits a profile of a low-growth, low-margin, high-supply-dependence generic antibiotic. Strategic attention should prioritize:

  • Manufacturing reliability and sterile facility readiness.
  • Contract retention and GPO positioning.
  • Alternative sourcing flexibility to reduce allocation-linked revenue swings.

Key Takeaways

  • Cephalothin’s market dynamics in the US are dominated by generic competition, contract pricing, and procurement-driven substitution rather than by innovation cycles.
  • The financial trajectory is typically low growth with periodic volatility tied to sterile injectable supply disruptions.
  • Competitive pressure comes from broader-spectrum beta-lactams and other first-generation cephalosporins that win formulary share when availability or price favors them.
  • For business planning, supply continuity and contract execution are the main levers that explain revenue variability more than demand expansion.

FAQs

  1. Why does cephalothin revenue fluctuate during hospital procurement cycles?
    Because institutional tenders and allocation during shortages can temporarily change net price and reorder timing.

  2. What drives hospital switching away from cephalothin to other antibiotics?
    Formularies, local antibiograms, stewardship protocols, and availability or pricing of alternative beta-lactams.

  3. How sensitive is cephalothin to manufacturing compliance events?
    Sterile injectable antibiotics often face rapid supply loss when validation or quality systems fail, which directly affects revenue and market share.

  4. Does cephalothin have growth potential versus newer cephalosporins?
    Generally limited, since clinical practice increasingly favors regimen choices that cover broader resistance profiles and align with evolving guidelines.

  5. What matters more for forecasting cephalothin than for newer drugs?
    Supplier uptime, lot reliability, contract status, and shortage history rather than exclusivity timelines.


References

(No sources were provided in the prompt, and no citations are included.)

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