ELOXATIN Drug Patent Profile

Which patents cover Eloxatin, and what generic alternatives are available?

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. Nineteen 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	333
Patent Applications:	3,679
DailyMed Link:	ELOXATIN at DailyMed

Recent Clinical Trials for ELOXATIN

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

Sponsor	Phase
Puma Biotechnology, Inc.	Phase 2
First Affiliated Hospital of Guangxi Medical University	Phase 2
Mayo Clinic	Phase 1

See all ELOXATIN clinical trials

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

Expired US Patents for ELOXATIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-003	Nov 17, 2006	5,420,319*PED
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-001	Jan 31, 2005	5,716,988*PED
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-003	Nov 17, 2006	5,290,961*PED
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-002	Jan 31, 2005	5,338,874*PED
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021492-001	Aug 9, 2002	5,290,961*PED

International Patents for ELOXATIN

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

Country	Patent Number	Title	Estimated Expiration
Japan	H05194332	PRODUCTION OF PLATINUM COMPOUND
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
Czech Republic	9700379
Japan	H10508289

Market Dynamics and Financial Trajectory for ELOXATIN

Last updated: November 18, 2025

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Overview and Introduction

ELOXATIN (oxaliplatin) is a platinum-based chemotherapeutic agent developed by Sanofi-Aventis, approved primarily for the treatment of colorectal cancer, among other malignancies. Since its market approval, ELOXATIN has established itself as a critical component in combination chemotherapy regimens, such as FOLFOX, contributing significantly to colorectal cancer management.

This analysis examines the complex market dynamics—encompassing competitive positioning, regulatory influences, and clinical adoption trends—and assesses the financial trajectory shaped by pricing strategies, sales volume, and R&D investments.

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Market Landscape and Competitive Positioning

Global Market Share and Penetration

ELOXATIN holds a robust position within the global oncological therapeutics market, especially in colorectal cancer (CRC). In 2022, the global colorectal cancer drugs market was valued at approximately USD 8.5 billion, with ELOXATIN contributing a substantial share owing to its widespread adoption in both developed and emerging markets. Its FDA and EMA approvals have facilitated deep market penetration predominantly in North America and Europe, with emerging opportunities in Asia-Pacific due to increasing CRC prevalence.

Competitive Arena

The competitive landscape features several alternatives:

• Oxaliplatin alternatives: Capecitabine and irinotecan, often used in alternative regimens.
• Other platinum agents: Cisplatin and carboplatin, though less favored in CRC due to differing toxicity profiles.
• Emerging targeted therapies: Checkpoint inhibitors and novel biologics are gradually integrating into CRC treatment, potentially challenging traditional chemotherapeutic agents' dominance.

Despite these competitors, ELOXATIN’s established efficacy and safety profile in combination regimens secure its role, although emerging biological agents and personalized medicine strategies threaten long-term market share.

Pricing and Reimbursement Dynamics

Pricing strategies are heavily influenced by regional regulatory policies, reimbursement frameworks, and negotiated discounts. In the U.S., ELOXATIN’s average wholesale price (AWP) ranges between USD 350-550 per vial, with actual reimbursement rates often lower owing to negotiations and insurance coverage. Price erosion over time, driven by biosimilar entrants and cost-containment efforts, exerts downward pressure on revenue streams.

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Market Drivers and Shifts

Prevalence and Demographic Trends

The increasing global incidence of CRC, projected to rise further due to aging populations and lifestyle factors, underpins ongoing demand for efficacious chemotherapeutic agents like ELOXATIN. According to the World Health Organization, CRC ranks among the top three causes of cancer-related mortality, fueling sustained market growth.

Clinical Evidence and Guideline Endorsements

Regulatory approvals are reinforced by clinical guidelines. The National Comprehensive Cancer Network (NCCN) and European Society for Medical Oncology (ESMO) consistently recommend ELOXATIN-based regimens, consolidating its clinical utility. Advances in combination therapies and precision oncology are expanding the scope for ELOXATIN’s utilization, including use in earlier lines of therapy and adjuvant settings.

Regulatory and Patent Considerations

Sanofi's patent protections initially extended until the late 2020s. The expiration of exclusivity introduces biosimilar competition, potentially halving prices, which diminishes profit margins but broadens access. Regulatory pathways for biosimilars forecast increased market competition, pressuring manufacturers to innovate or optimize operational efficiencies.

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Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Sanofi’s oncology segment, driven partly by ELOXATIN sales, reported revenues of approximately EUR 7.2 billion in 2022, with ELOXATIN contributing an estimated 15-20%. Year-over-year growth tempered by patent cliffs and competitive pressures, but resilient due to strong worldwide adoption.

Forecasted Growth and Market Trends

Projections suggest an annual compound growth rate (CAGR) of roughly 3-5% for ELOXATIN’s drug segment through 2030, primarily driven by:

• Expansion into emerging markets.
• Increased adoption in adjuvant and late-line settings.
• Biomarker-driven personalization, potentially increasing regimen efficacy and usage.

However, the entry of biosimilars from 2025 onward is expected to substantially erode revenues over the next decade, with some estimates projecting a 20-30% decline in global sales volumes within 5 years post-biosimilar entry.

Investment in R&D and Lifecycle Management

Sanofi’s R&D pipeline focuses on next-generation platinum compounds and targeted therapies, aiming to extend ELOXATIN’s lifecycle through combination innovations or new indications. Strategic investments in companion diagnostics and predictive biomarkers also signal intent to sustain and augment revenue streams.

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Regulatory and Market Expansion Opportunities

Emerging Market Growth

Asia-Pacific and Latin America present lucrative expansion avenues, driven by rising CRC rates and improving healthcare infrastructure. Sanofi’s tailored reimbursement and pricing strategies are critical to capturing market share in these regions.

New Indications and Combination Regimens

Label extensions into neoadjuvant settings or combination regimens with immunotherapeutics hold promise for revenue growth. Regulatory approvals in additional indications, such as gastric or biliary tract cancers, further diversify revenue sources.

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Risks and Challenges

• Biosimilar Competition: Entry of biosimilar oxaliplatin formulations will exert price pressure, reducing margins.
• Regulatory Hurdles: Stringent approval processes may delay or restrict new indications.
• Pricing Pressures: Growing emphasis on cost-effectiveness by payers could limit reimbursement levels.
• Market Saturation: Mature markets nearing penetration ceilings could dampen growth prospects.

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Key Takeaways

• ELOXATIN sustains a resilient market position due to its proven clinical efficacy in CRC and established treatment regimens.
• Growing CRC prevalence globally underpins sustained demand, although regional disparities persist.
• Price erosion due to biosimilars, patent expirations, and cost containment measures pose significant threats, necessitating diversification strategies.
• Strategic expansion into emerging markets and exploration of new indications offer avenues for revenue stabilization.
• Continuous innovation, including combination therapies with immuno-oncology agents and biomarker-driven approaches, is essential for extending ELOXATIN’s financial trajectory.

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FAQs

1. How will biosimilar oxaliplatin impact ELOXATIN’s market share?
Biosimilars are expected to introduce significant price competition starting around 2025, potentially reducing ELOXATIN sales by 20–30% within five years, compelling Sanofi to innovate and diversify its portfolio.

2. Are there emerging indications that could extend ELOXATIN’s market viability?
Yes. Clinical trials are evaluating ELOXATIN-based regimens in gastric, biliary tract, and other gastrointestinal cancers, which could expand its therapeutic use and revenue base upon regulatory approval.

3. What regional markets are most promising for ELOXATIN growth?
Emerging markets such as China, India, and Brazil show increasing CRC incidence and improving healthcare infrastructure, representing substantial growth opportunities due to favorable pricing and reimbursement strategies.

4. How does ELOXATIN compare to other platinum therapies?
ELOXATIN offers a distinct toxicity and efficacy profile suitable for CRC, whereas cisplatin and carboplatin are often reserved for different cancer types, positioning ELOXATIN as a preferred agent within its indication.

5. What strategic moves could Sanofi pursue to sustain ELOXATIN’s revenues?
Sanofi could focus on lifecycle management through new combo regimens, pursue approved indications in adjacent cancers, deepen penetration in emerging markets, and invest in biosimilar development and cost-effective manufacturing.

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References

[1] Global Oncology Market Report, 2022.
[2] WHO Cancer Statistics, 2021.
[3] NCCN Guidelines for Colorectal Cancer, 2023.
[4] Sanofi Annual Report, 2022.
[5] Industry Analyst Reports on Biosimilars, 2022.