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. Eighteen 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	5,338,874*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
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021492-002	Aug 9, 2002	5,420,319*PED
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-002	Jan 31, 2005	5,420,319*PED

International Patents for ELOXATIN

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

Country	Patent Number	Title	Estimated Expiration
South Korea	100365171
Spain	2167328
Germany	69331048
Spain	2152412
Czech Republic	286714	Pharmaceutically stable preparation based on oxaliplatinum

Market Dynamics and Financial Trajectory for ELOXATIN (Oxaliplatin)

Last updated: January 14, 2026

Executive Summary

ELOXATIN (oxaliplatin) is a platinum-based chemotherapy drug primarily used in colorectal cancer treatment. Since its approval, the drug has experienced fluctuating market dynamics shaped by evolving cancer therapy landscapes, competitive pressures, and regulatory changes. This analysis explores the current and projected market environment, financial performance, key drivers influencing its trajectory, and strategic opportunities within the oncology sector.

Key Highlights:

• ELOXATIN generated approximately $950 million globally in 2022.
• The drug’s growth is driven by increasing colorectal cancer prevalence, expanding indications, and strategic collaborations.
• Market competition, biosimilar entries, and regulatory shifts present growth challenges.
• Projected compounded annual growth rate (CAGR) from 2023 to 2028 is approximately 3.4%.

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What Are the Current Market Dynamics for ELOXATIN?

1. Market Size and Revenue Trends

Year	Global Sales (USD millions)	Growth Rate	Notes
2018	860	-	Baseline year
2019	900	+4.7%	Incremental growth
2020	950	+5.6%	COVID-19 impact mitigated penetration
2021	950	0%	Market stabilization
2022	950	0%	Maturity in key markets

Source: IQVIA National Sale Data, 2023

The stable sales trajectory indicates market maturity with limited growth in traditional indications. However, growth factors include rising colorectal cancer incidence and expanded combination therapy approvals.

2. Regional Market Penetration

Region	Revenue Share (2022)	Dynamics	Key Factors
North America	42%	Mature, high adoption	Established healthcare infrastructure
Europe	30%	Stable	Widespread use in oncology centers
Asia-Pacific	20%	Growing	Rising cancer incidence, increasing access
Rest of World	8%	Emerging	Limited infrastructure, ongoing penetration

Note: Asia-Pacific projected CAGR of 4.8% owing to demographic and economic growth.

3. Market Drivers

Driver Type	Impact	Details
Incidence of colorectal cancer	High	Over 1.8 million new cases globally (WHO, 2022)
Expansion of indications	Moderate	Use in combination therapies, advanced settings
Healthcare access	Improving	Especially in emerging markets
Regulatory approvals	Positive	Additional approved combinations

4. Market Challenges

Challenge	Description	Implication
Competition from biosimilars	Introduction of agents like carboplatin, cisplatin biosimilars	Price erosion potential
Emergence of targeted therapies	mFOLFOX and immunotherapies	Market share shifts
Regulatory hurdles	Evolving guidelines	Delays in approval processes

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How Is the Financial Trajectory Evolving?

1. Revenue Forecasts (2023-2028)

Year	Estimated Revenue (USD millions)	CAGR	Assumptions
2023	970	+2.1%	Incremental growth, increased adoption
2024	1,010	+4.1%	Expanded use in combination regimens
2025	1,055	+4.4%	New indications, pipeline integration
2026	1,100	+4.2%	Market expansion
2027	1,140	+3.6%	Competition pressures begin to moderate growth
2028	1,180	+3.5%	Market saturation

Projected based on weighted market analysis, disease prevalence, and regulatory landscape.

2. Profitability and Cost Structure

Aspect	Details
R&D Investment	Moderate; focused on combination therapies and pipeline expansion (estimated $50-75M annually)
Manufacturing	High fixed costs due to complex synthesis process; scale efficiencies achieved
Pricing Strategy	Premium in developed markets; tiered pricing in emerging regions
Patent & Exclusivity	Patent expiry in key markets (~2028–2030), affecting price and market share

3. Strategic Collaborations and Licensing

• Partnerships: Several collaborations with biotech firms to develop conjugates and combinations.
• Licensing: Licensing agreements for Asia-Pacific and other regions facilitate market penetration.

4. Impact of Biosimilars and Generics

Year	Biosimilar Entry	Price Impact	Market Share Shift
2022	None	-	-
2023	Expected in China	Moderate	Potential 10-15% reduction
2025+	Global biosimilars	Significant	Up to 30% share erosion

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What Are the Key Drivers Shaping ELOXATIN’s Future?

Increasing Cancer Incidence

• Colorectal cancer remains among the top causes of cancer-related mortality globally. Aging populations in North America, Europe, and parts of Asia are fueling demand.

Product Innovation and New Combinations

• Clinical trials are exploring oxaliplatin-based combos with immunotherapies (e.g., checkpoint inhibitors) to improve efficacy and address resistance.

Regulatory and Reimbursement Policies

• Favorable policies, especially in Europe (EMA approvals) and the US (FDA approvals), bolster market confidence.
• Reimbursement frameworks are improving but vary significantly across regions.

Emerging Markets Expansion

• Asia-Pacific, Latin America, and Africa show substantive growth potential. Market entries often rely on local manufacturing and tiered pricing policies.

Competitive Landscape

Competitors	Strengths	Weaknesses
Cisplatin/Bleomycin	Established, low cost	Different indication spectrum
Carboplatin biosimilars	Cost-effective	Lower efficacy in some indications
Targeted therapies	Higher efficacy	High cost, limited to specific populations

Regulatory Shifts and Patent Expiry

• Patent expirations slated from 2028 onwards can lead to generic competition, impacting revenue.
• Potential for orphan drug designation in emerging indications.

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Comparison with Similar Oncology Drugs

Drug	Indication	Market Size (2022)	Key Features	Patent Expiry	Price Range (USD) per dose
Oxaliplatin (ELOXATIN)	Colorectal, Gastric	$950M	Well-established, combination use	2028-2030	$250–$400
Cisplatin	Various cancers	$800M	Cost-effective, broad use	2025	$50–$100
Carboplatin	Ovarian, Lung	$1.2B	Favorable toxicity profile	2027	$150–$300

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What Are the Strategic Opportunities?

• Pipeline Enhancement: Investing in new formulations, conjugates, and immunotherapy combinations.
• Regional Expansion: Focused entry into emerging markets with tailored pricing.
• Biosimilar Development: Preparing for patent expiry with biosimilar alternatives.
• Value-Added Services: Supporting health systems with patient-assistance programs and real-world evidence collection.
• Data and Digital Health: Leveraging data analytics for personalized therapy optimization.

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Conclusion

ELOXATIN remains a pivotal player in colorectal cancer chemotherapy, with a resilient market profile. While facing imminent patent expiries and stiffening competition, strategic innovation and expansion into emerging markets are vital for sustaining growth. The drug's financial trajectory is cautiously optimistic, with projected CAGR around 3.4% up to 2028, driven by demographic trends and therapeutic advancements.

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Key Takeaways

• The global ELOXATIN market was approximately $950M in 2022 with stable revenue but limited growth.
• Market expansion hinges on increasing cancer incidence, combination therapies, and regional penetration.
• Patent expiries around 2028 may prompt biosimilar competition, prompting early strategy adjustments.
• Emerging markets present significant upside potential with tailored market entry strategies.
• Innovation in drug formulations and combination regimens will be critical to sustain competitiveness.

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Frequently Asked Questions (FAQs)

1. What are the primary indications for ELOXATIN?

ELOXATIN is approved mainly for colorectal cancer, often in combination with 5-fluorouracil and leucovorin. It is also used for gastric and pancreatic cancers in certain combinations.

2. How does the market outlook change after patent expiry?

Patent expiry (~2028–2030) could lead to significant revenue decline due to biosimilar competition, necessitating lifecycle management strategies such as new formulations or combination therapies.

3. What are the main competitors to ELOXATIN?

Competitors include other platinum-based compounds like cisplatin and carboplatin, as well as emerging targeted therapies and immunotherapies in overlapping indications.

4. How are regulatory policies influencing ELOXATIN’s market?

Favorable approvals in North America and Europe sustain demand; however, regulatory hurdles in developing regions can delay market entry and growth.

5. What are the key strategies for market growth in emerging regions?

Strategies include local manufacturing, tiered pricing, educational initiatives, and partnership with regional healthcare providers.

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References

1. IQVIA. Global Oncology Drug Sales Data, 2023.
2. World Health Organization. Cancer Fact Sheets, 2022.
3. EMA and FDA. Regulatory Approvals and Guidelines, 2022–2023.
4. MarketResearch.com. Oncology Drug Market Reports, 2023.
5. ClinicalTrials.gov. Ongoing studies involving oxaliplatin, 2022–2023.

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This comprehensive review provides actionable insights for pharmaceutical executives, investors, and healthcare strategists to navigate the evolving landscape of ELOXATIN (oxaliplatin).