ELOXATIN Drug Patent Profile

When do Eloxatin patents expire, and when can generic versions of Eloxatin launch?

Eloxatin is a drug marketed by Sanofi Aventis Us and is included in two NDAs.

The generic ingredient in ELOXATIN is oxaliplatin. There are twenty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the oxaliplatin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Eloxatin

A generic version of ELOXATIN was approved as oxaliplatin by HOSPIRA WORLDWIDE on August 7^th, 2009.

Summary for ELOXATIN

US Patents:	0
Applicants:	1
NDAs:	2

Paragraph IV (Patent) Challenges for ELOXATIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ELOXATIN	Injection	oxaliplatin	5 mg/mL, 40 mL vials	021759	1	2007-07-16
ELOXATIN	Injection	oxaliplatin	5 mg/mL, 10 mL and 20 mL vials	021759	11	2007-02-09

US Patents and Regulatory Information for ELOXATIN

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	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021492-001	Aug 9, 2002		DISCN	Yes	No
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-002	Jan 31, 2005		DISCN	Yes	No
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-001	Jan 31, 2005		DISCN	Yes	No
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021492-002	Aug 9, 2002		DISCN	Yes	No
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-003	Nov 17, 2006		DISCN	Yes	No

International Patents for ELOXATIN

See the table below for patents covering ELOXATIN around the world.

Country	Patent Number	Title	Estimated Expiration
Czech Republic	286714	Pharmaceutically stable preparation based on oxaliplatinum
Japan	H06329692	OPTICALLY HIGH-PURITY CIS-OXALATE (TRANS-L-1,2-CYCLOHEXANEDIAMINE) PLATINUM (II) COMPLEX AND ITS PRODUCTION
Russian Federation	2148400	PHARMACEUTICALLY STABLE PREPARATION OF OXALYPLATINUM
Japan	H0776230
European Patent Office	0617043	Composé de platine et procédé pour sa préparation (Platinum compound and process of preparing same)

ELOXATIN (oxaliplatin): Investment scenario and fundamentals analysis

Last updated: April 25, 2026

What is ELOXATIN and where does it sit in the platinum oncology landscape?

ELOXATIN is a brand of oxaliplatin, a third-generation platinum chemotherapy drug used in oncology, most prominently in colorectal cancer regimens (often combined with fluoropyrimidines such as 5-FU or capecitabine and, in some settings, with biologics or other agents).

From an investment lens, oxaliplatin is not a “platform” asset in the way targeted oncology agents are. Its value chain typically hinges on:

• competitive positioning in branded vs. generic markets
• supply execution and pricing durability
• cycle-time of regulatory and tender pricing
• distribution reach and hospital formulary adoption

Key implication: “fundamentals” for oxaliplatin are more closely tied to trade dynamics and manufacturing economics than to late-stage differentiation, because the active substance is well-established.

What is the revenue model under real-world procurement and reimbursement?

Oxaliplatin products usually monetize through:

• hospital procurement (tender-driven pricing, tender compliance, and stock-management performance)
• oncology regimen adoption (physician preference anchored on efficacy and historical protocols)
• payers’ reimbursement rules (where brand placement can matter in restricted formularies)

For investors, this means the core drivers are:

• market share in oncology service lines
• net price versus listed price (discounts, tender concessions, rebate structures)
• effective gross margin after supply-chain and logistics costs
• volume stability in CRC regimens and cyclic treatment schedules

How mature is the IP and what does that mean for upside?

Oxaliplatin is a legacy molecule with mature clinical and regulatory standing. In practical terms for investments, the molecule typically faces:

• generic entry pressure
• reformulation and packaging differentiation rather than new MOA differentiation
• brand value compression unless a product holds a protected formulation/market authorization structure in a specific jurisdiction

Upside is usually constrained to:

• countries where brand authorization remains defensible
• niches where competitive products have supply constraints
• settings where procurement awards favor established suppliers

Downside is structurally exposed to:

• generic pricing cliffs
• tender resets
• regulatory re-registrations that can favor incumbents or low-cost producers

What are the core clinical and regimen fundamentals for oxaliplatin exposure?

Oxaliplatin is used in standard chemotherapy regimens in:

• metastatic colorectal cancer
• adjuvant colorectal cancer (depending on stage and regimen selection)

In portfolio modeling, the relevant “fundamentals” are not new endpoints; they are:

• treatment-line incidence for CRC
• cycle adherence
• regimen substitution patterns (how often oxaliplatin is used vs. alternatives in practice)
• patient tolerability (neuropathy management affects dose intensity and discontinuation rates)

What are the key demand drivers and risk factors for ELOXATIN volumes?

Demand drivers (typical)

1) CRC incidence and survival trends supporting ongoing chemotherapy usage
2) protocol continuity in standard-of-care regimens
3) hospital formulary inertia (switching costs favor incumbents when supplies are reliable)

Risk factors (typical)

1) generic-led price erosion
2) tender-driven volume reallocation across suppliers
3) supply reliability and manufacturing yield risks, which directly impact hospital continuity of care
4) clinical tolerability constraints affecting dose intensity (not usually a “brand risk,” but it affects net usage per patient)

What does “product economics” look like in legacy oncology chemotherapy?

Oxaliplatin’s economics tend to be dominated by:

• manufacturing cost curve (scale, raw material access, and purity/quality margins)
• cold-chain and handling requirements (where applicable) driving logistics cost
• waste and vial utilization (dose rounding to vial sizes affects discard rates)
• regulatory/compliance costs (GMP and local pharmacovigilance obligations)

For ELOXATIN specifically, the investment takeaway is that the winner is often the supplier with:

• consistent manufacturing and fill-finish performance
• stable supply that can win hospital tenders
• lower landed cost that protects net margin after discounts

What could an investment scenario look like across 3 horizons?

Because oxaliplatin is mature, scenarios are typically framed around market share and price rather than clinical breakthroughs.

Base case (share stable, pricing moderate compression)

• Net prices drift downward with inflation-adjusted generics entry
• Volumes remain stable if supply performance is strong
• Margin erodes gradually; cash generation remains meaningful

Bear case (tender reset + accelerated generic substitution)

• Abrupt price drop at tender cycles
• Volume loss to lower-cost entrants
• Higher working capital needs due to distribution adjustments and rebate mechanics

Bull case (formulary access + supply advantage)

• ELOXATIN maintains or gains share in specific geographies
• Lower effective discounting due to procurement confidence
• Margin stabilizes relative to peers despite generic pressure

How to underwrite ELOXATIN using a practical fundamentals framework

An actionable underwriting model for ELOXATIN should prioritize:

1) Net revenue and margin bridge

• Gross-to-net assumptions: tender discounts, distributor margins, rebates
• Manufacturing COGS per dose: scale and yield
• Logistics cost per vials per shipment: cold chain handling and wastage

2) Market share and unit volume

• CRC regimen incidence and local protocol usage patterns
• Hospital tender concentration: top accounts and contract durations
• Competitive set: branded legacy vs generic suppliers

3) Regulatory and supply continuity

• product availability: stockouts and allocation risk
• local authorization status (market-specific exposure)
• pharmacovigilance and quality systems (risk of suspension or restricted supply)

What are the competitive implications of oxaliplatin’s maturity?

Investors should assume competition on:

• price
• supply reliability
• documentation and tender readiness
• substitution policies

Differentiation is usually not clinical. It is operational:

• lower landed cost
• better tender terms
• fewer disruptions

Key takeaways for ELOXATIN’s investment fundamentals

• ELOXATIN is oxaliplatin, a mature oncology chemotherapy with stable clinical positioning but limited patent-like upside in most markets due to generic pressure.
• The investment case depends on trade economics: net price, hospital tender share, and supply-chain execution.
• Base case is gradual margin compression; upside comes from share gains or procurement advantages; downside comes from tender resets and rapid generic substitution.
• Underwrite via margin bridge + tender dynamics, not by expecting new clinical differentiation.

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Key Takeaways

• ELOXATIN (oxaliplatin) is a legacy oncology asset where fundamentals are driven by pricing, procurement, and supply reliability.
• Investment scenarios should be modeled around net revenue compression and unit volume shifts due to tender cycles and generic substitution.
• The primary lever is hospital/formulary share secured through operational performance, not new therapeutic differentiation.

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FAQs

1) Is ELOXATIN likely to face generic substitution risk?

Yes. Oxaliplatin is a mature molecule, and markets with established generic options typically see pressure on branded pricing through tender competition.

2) What most affects ELOXATIN’s quarterly performance?

Tender cycles and hospital procurement behavior, which determine net pricing and unit volume. Supply continuity also affects missed or delayed purchases.

3) Does brand marketing drive ELOXATIN demand?

Demand is usually driven by standard-of-care regimen adoption and procurement mechanics rather than marketing. Physician influence matters, but purchasing decisions are procurement-led.

4) What is the main margin risk for oxaliplatin products?

Gross-to-net erosion from discounts and rebates after tenders reset, plus manufacturing and logistics costs influenced by scale and wastage.

5) What defines a sustainable investment upside for ELOXATIN?

Share retention or gains in specific geographies where the supplier holds procurement advantage through reliable supply and competitive landed cost.

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References

[1] European Medicines Agency (EMA). Oxaliplatin product information and EPAR documents. European Union.
[2] U.S. Food and Drug Administration (FDA). Oxaliplatin drug labeling and safety/efficacy summaries. U.S. FDA.
[3] NCCN Guidelines. Colon Cancer (oxaliplatin-based regimens within treatment frameworks). National Comprehensive Cancer Network.
[4] WHO ATC classification. L01XA: Platins (oxaliplatin therapeutic class mapping). World Health Organization.