Last Updated: June 17, 2026

CLAFORAN Drug Patent Profile


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Which patents cover Claforan, and when can generic versions of Claforan launch?

Claforan is a drug marketed by Sanofi Aventis Us and Sterimax and is included in three NDAs.

The generic ingredient in CLAFORAN is cefotaxime sodium. There are fourteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cefotaxime sodium profile page.

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Summary for CLAFORAN
Recent Clinical Trials for CLAFORAN

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

SponsorPhase
Håkan HanbergerPhase 4
University Medical Center GroningenPhase 4
University of California, San FranciscoPhase 1

See all CLAFORAN clinical trials

US Patents and Regulatory Information for CLAFORAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us CLAFORAN cefotaxime sodium INJECTABLE;INJECTION 062659-001 Jan 13, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sterimax CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER cefotaxime sodium INJECTABLE;INJECTION 050596-002 May 20, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sterimax CLAFORAN cefotaxime sodium INJECTABLE;INJECTION 050547-003 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sterimax CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER cefotaxime sodium INJECTABLE;INJECTION 050596-004 May 20, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sanofi Aventis Us CLAFORAN cefotaxime sodium INJECTABLE;INJECTION 062659-002 Jan 13, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sterimax CLAFORAN cefotaxime sodium INJECTABLE;INJECTION 050547-002 Approved Prior to Jan 1, 1982 DISCN Yes 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: April 25, 2026

CLAFORAN: Market Dynamics and Financial Trajectory

What is CLAFORAN’s commercial footprint by product form and geography?

CLAFORAN is the brand name for cefotaxime sodium (a 3rd-generation cephalosporin). Commercial dynamics differ sharply by supply chain structure, reimbursement regimes, and competitive generics across core markets (EU and US). The brand’s trajectory is constrained by two forces that typically dominate injectable antibiotics: (1) rapid generic entry and (2) tender-driven procurement that compresses prices.

Market footprint shape (injectable antibiotic reality):

  • Buyer model: hospitals, government procurement, and group purchasing organizations (GPOs)
  • Purchase mechanism: tenders, contract renewals, and formulary status rather than retail uptake
  • Pricing mechanism: steep downtrend after generic availability and contract rebids

Regulatory status driving uptake (EU and US pattern):

  • In the EU, cefotaxime is widely authorized and supplied as generics.
  • In the US, cefotaxime products are supplied through multiple generic entrants, with brand exposure limited to earlier periods and constrained current sales.

Net effect: CLAFORAN behaves like a classic “originator antibiotic brand” where share and price erode after patent/market exclusivity ends, while volumes persist in the generic ecosystem through substitution.


What market dynamics have defined CLAFORAN’s performance over time?

The financial trajectory of CLAFORAN tracks the standard lifecycle of injectable antibiotics, with specific dynamics:

1) Patent and exclusivity decay and substitution economics

Cefotaxime’s commercial cycle has been shaped by:

  • generic substitution after exclusivity windows
  • price competition at tender level
  • conversion of procurement to lowest net cost plus contractual terms

This drives two outcomes:

  • Revenue compression even when demand persists
  • Margin compression as brand premiums disappear

2) Hospital formulary lock-in versus rebid volatility

Injectables can remain on formulary for extended periods, but tenders can reprice abruptly. When contracts end, buyers rebid using:

  • unit price
  • logistics reliability (supply continuity)
  • stock availability and lead times
  • pharmacist and infection-control protocols

For an originator brand, the rebid cycle is typically negative after generic penetration because originator status no longer compensates for higher net price.

3) Antibiotic utilization governance

Hospital use depends on antimicrobial stewardship and local resistance patterns. Cefotaxime usage is sensitive to:

  • guideline alignment (empiric therapy pathways)
  • stewardship restrictions
  • shifts to alternative beta-lactams where formularies prefer narrower-spectrum or more targeted agents

This does not eliminate demand for cefotaxime, but it can limit incremental volume growth for the brand.


How does CLAFORAN’s pricing and revenue trend typically evolve under generic competition?

Without brand-specific financial disclosures for every jurisdiction, the defensible pattern for an originator cefotaxime brand is:

Post-generic phase dynamics

  • Unit prices fall first, driven by tender benchmarks
  • Brand share declines via substitution to equivalent generic cefotaxime sodium formulations
  • Originator revenue falls faster than total market because the originator premium disappears
  • Margin becomes structurally constrained because procurement awards typically converge toward the lowest net cost

In practice, CLAFORAN’s financial outcome is usually characterized by:

  • declining or stagnating volumes relative to the total cefotaxime market after substitution
  • sharply reduced brand pricing power
  • potential survival in specific institutional contracts or regions where originator supply or historical procurement practices persist

What is the likely financial trajectory of CLAFORAN across the drug lifecycle?

A lifecycle-consistent trajectory for CLAFORAN can be mapped to three phases:

Phase A: Growth and peak brand pricing (earlier market window)

  • Brand differentiation supported by exclusivity and procurement preference
  • Stable hospital adoption for empiric and targeted indications

Phase B: Generic entry and share erosion

  • Rapid conversion to generics once equivalent supply scales
  • Revenue decline as the brand loses tender competitions
  • Contract losses tend to accelerate declines because hospital budgets respond quickly to price gaps

Phase C: Mature, residual brand presence

  • CLAFORAN persists mainly where:
    • contracts renew with originator supply
    • supply chain constraints temporarily favor established vendors
    • formulary decisions retain historical products
  • Ongoing revenue becomes “survival-level,” tied to specific procurement niches rather than market-wide share gains

This lifecycle pattern is consistent with how injectable antibiotic originator brands typically perform once multiple generic equivalents exist.


Where does CLAFORAN face competitive pressure from adjacent therapies?

Cefotaxime faces substitution not only from generic cefotaxime but also from competing antibiotic classes in hospital empiric pathways. Competitive pressure is strongest where guidelines prefer:

  • other cephalosporins with preferred spectra or dosing convenience
  • beta-lactam/beta-lactamase inhibitor combinations
  • carbapenems in severe resistant cases (more constrained use, but can displace cefotaxime in the highest acuity segments)

For CLAFORAN, this competition reduces the upside from any incremental demand growth. It also makes brand recoveries unlikely once generics are entrenched.


How do regulatory labeling and product identity constrain commercial substitution?

Product substitution typically requires:

  • therapeutic equivalence
  • comparable strength and formulation
  • same route (injectable)
  • consistent quality and supply continuity

CLAFORAN’s identity as cefotaxime sodium supports broad substitutability once generics meet bioequivalence or reference standards. That reduces the ability of the brand to retain pricing power through “brand-specific” clinical differentiation.


What do the core product specifications imply for marketability and procurement?

For hospital procurement, two practical properties govern adoption:

  • Efficacy class: third-generation cephalosporin, commonly used in empiric and targeted regimens
  • Form factor: injectable cefotaxime sodium, compatible with inpatient protocols

These attributes maintain demand for the molecule category, but they do not protect brand economics once equivalent generics exist.


What are the highest-impact business indicators to track for CLAFORAN?

For a drug like CLAFORAN in mature antibiotic markets, financial trajectory aligns with procurement and substitution signals rather than headline “market growth”:

Indicator Why it matters What typically happens after generic entry
Tender award outcomes Determines net revenue quickly Originator share declines after rebids
Net unit price vs. generic reference Drives margin and revenue Converges toward lowest-cost alternatives
Hospital formulary retention Impacts continuity of volume Retention falls as contracts reset
Supply continuity and lead times Affects purchasing trust in injectables Strong suppliers retain small residual share

What is the actionable investment and R&D takeaway from CLAFORAN’s dynamics?

For investors and R&D planners, CLAFORAN’s market mechanics imply:

  • Injectable antibiotics in mature markets monetize primarily through contract positioning, not brand premium
  • Commercial upside is limited for originator brands once generics dominate tender economics
  • New entrants typically compete on cost, supply reliability, and dosing practicality, not novel efficacy for a commodity molecule

The ceiling on brand financial recovery rises only if one of the following changes materially:

  • supply disruptions among generic producers
  • formulation or presentation advantages that alter procurement rules
  • restrictive stewardship changes that re-balance empiric selections in favor of cefotaxime (rather than alternatives)

Key Takeaways

  • CLAFORAN’s market dynamics are dominated by tender-driven procurement and generic substitution for cefotaxime sodium injectables.
  • Its financial trajectory follows a typical originator-in-commodity pattern: brand pricing power declines first, then share and revenue compress after contract losses.
  • Residual CLAFORAN presence is likely limited to specific procurement niches, while overall cefotaxime demand continues within the broader generic ecosystem.
  • The commercial KPI set for CLAFORAN is procurement-focused: tender outcomes, net unit price convergence, formulary retention, and supply continuity.

FAQs

1) What is CLAFORAN?
CLAFORAN is the brand name for cefotaxime sodium, an injectable third-generation cephalosporin.

2) Why does CLAFORAN’s revenue typically fall after generic entry?
Hospital procurement uses tenders and net pricing; equivalent generic cefotaxime forces unit prices down and shifts volume to lower-cost suppliers.

3) Does cefotaxime still sell if generics dominate?
Yes. The molecule remains clinically used, but sales typically migrate to generic cefotaxime suppliers, compressing the branded originator economics.

4) What commercial factors matter most for injectable antibiotics?
Tender wins, net unit pricing versus benchmarks, formulary access, and supply reliability.

5) What could reverse branded CLAFORAN economics in a mature market?
Only material procurement or market structure changes, such as generic supply constraints or formulation/presentation advantages that alter contract awards.


References

[1] PubChem. Cefotaxime. https://pubchem.ncbi.nlm.nih.gov/compound/Cefotaxime.
[2] FDA. Drug Approval Package: Cefotaxime. https://www.accessdata.fda.gov/scripts/cder/daf/.
[3] EMA. Cefotaxime-related materials and regulatory information (European framework). https://www.ema.europa.eu/en.

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