Oxaliplatin - Generic Drug Details

What are the generic drug sources for oxaliplatin and what is the scope of patent protection?

Oxaliplatin is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Accord Hlthcare, Actavis, Actavis Totowa, Am Regent, Chartwell Molecular, Eugia Pharma, Fresenius Kabi Oncol, Fresenius Kabi Usa, Gland, Hengrui Pharma, Hetero Labs Ltd Vi, Hospira Inc, Hospira Worldwide, Meitheal, Mylan Labs Ltd, Novast Labs, Pharmobedient, Qilu Pharm Hainan, Sandoz, Sun Pharm, and Teva Pharms, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for oxaliplatin. Nineteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for oxaliplatin

US Patents:	0
Tradenames:	2
Applicants:	22
NDAs:	30
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2,376
Patent Applications:	7,054
Drug Prices:	Drug price trends for oxaliplatin
What excipients (inactive ingredients) are in oxaliplatin?	oxaliplatin excipients list
DailyMed Link:	oxaliplatin at DailyMed

See drug prices for oxaliplatin

Recent Clinical Trials for oxaliplatin

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

Sponsor	Phase
Medical University of South Carolina	PHASE2
Tao Zhang	PHASE3
UNICANCER	PHASE3

See all oxaliplatin clinical trials

Generic filers with tentative approvals for OXALIPLATIN

Applicant	Application No.	Strength	Dosage Form
		5MG/ML	INJECTABLE; INJECTION
		100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS
		50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for oxaliplatin

Drug Class

Platinum-based Drug

Anatomical Therapeutic Chemical (ATC) Classes for oxaliplatin

L01XA	Platinum compounds
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for OXALIPLATIN

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 oxaliplatin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Qilu Pharm Hainan	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	204616-001	May 11, 2016	AP	RX	No	No
Accord Hlthcare	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	207474-001	Mar 21, 2017	AP	RX	No	No
Fresenius Kabi Usa	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	078819-001	Jun 2, 2010	AP	RX	No	No

Expired US Patents for oxaliplatin

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

Market Dynamics and Financial Trajectory for Oxaliplatin

Last updated: July 28, 2025

Introduction

Oxaliplatin, a platinum-based chemotherapeutic agent, remains a cornerstone in the treatment of colorectal cancer (CRC) and other gastrointestinal malignancies. Since its approval by the U.S. Food and Drug Administration (FDA) in 2004, oxaliplatin has experienced evolving market dynamics driven by clinical advancements, patent landscapes, competitive developments, and emerging treatment paradigms. This analysis explores the current market landscape, the financial trajectory of oxaliplatin, and the factors poised to influence its future trajectory within the global pharmaceutical ecosystem.

Pharmacological Profile and Clinical Significance

Oxaliplatin functions as a DNA crosslinker, inducing apoptosis in proliferating cells. Its inclusion in combination regimens such as FOLFOX (folinic acid, fluorouracil, and oxaliplatin) has optimized colorectal cancer treatment outcomes, extending survival benchmarks [1]. The drug's approval was predicated on its superiority in improving progression-free survival (PFS) and overall survival (OS), notably in metastatic settings.

Clinical guidelines worldwide, including NCCN and ESMO, position oxaliplatin as a pivotal agent in first-line therapy for CRC, reaffirming its clinical value [2]. Its efficacy against diverse tumor subtypes sustains an ongoing demand, particularly in combination therapies designed to overcome resistance.

Market Dynamics

Research and Development Trends

The import of oxaliplatin has historically been framed by its clinical efficacy; however, recent research pivots toward next-generation platinum compounds with better toxicity profiles and spectrum of activity. While new formulations aim to enhance pharmacokinetics and reduce adverse effects like peripheral neuropathy—a notable side effect—the foundational role of oxaliplatin remains unchallenged in current treatment algorithms [3].

Patent and Regulatory Landscape

Original patents on oxaliplatin have long expired, prompting generic manufacturers to enter the market. This proliferation has significantly reduced drug prices and expanded global access, especially in emerging markets. Nonetheless, the expiration of exclusivity has catalyzed intense price competition but also challenges profitability for original developers [4].

Market Penetration and Adoption

In high-income regions, oxaliplatin’s utilization remains robust, supported by extensive clinical evidence and guideline endorsements. However, in low- and middle-income countries, market penetration still faces barriers—cost constraints, lack of infrastructure, and regulatory hurdles—limiting widespread adoption. Furthermore, variations in clinical practice influence prescription rates, with some trends favoring alternative agents or targeted therapies as they become available.

Competitive Landscape

While oxaliplatin was initially unique, the advent of other platinum compounds such as carboplatin and cisplatin introduced competition, especially in certain indications. The development of targeted therapies—including anti-EGFR and anti-VEGF agents—has gradually shifted treatment paradigms, integrating oxaliplatin as part of combination regimens rather than standalone options. Immunotherapy advances also influence the oncology drug landscape, although their direct impact on oxaliplatin remains limited at present.

Pricing and Market Access

Generic production has driven prices downward, increasing affordability. However, reimbursement policies vary by geography, influencing access. In markets like the U.S., insurance and Medicare policies determine cost-effectiveness thresholds, affecting prescription patterns [5].

Emerging Trends

Several ongoing clinical trials investigate oxaliplatin-based regimens in novel indications such as hepatocellular carcinoma and gastric cancers, expanding its application scope. Biomarker-driven approaches and personalized medicine frameworks aim to optimize patient selection, potentially enhancing therapeutic efficacy and cost-effectiveness.

Financial Trajectory

Revenue Trends

Since patent expiration, revenue from oxaliplatin formulations has experienced a decline, typical of many branded chemotherapeutics facing generic competition. Nonetheless, global sales persist owing to its integration into essential chemotherapy protocols, with estimates indicating a continued, albeit modest, revenue stream primarily from developed markets [6].

Market Forecasts

Analysts project that the global oxaliplatin market will stabilize or decline gradually over the next five years, aligning with the saturation of current indications. However, the expansion into new oncological indications and combination regimens could offset declines. Additionally, markets in Asia-Pacific, Latin America, and Africa are expected to demonstrate growth due to increased cancer screening and healthcare infrastructure investments.

Pricing Dynamics

The transition to generics has resulted in significant price erosion. A typical 2019 analysis depicted generic oxaliplatin's price reductions of approximately 70–90% from branded prices, influencing overall market size and profitability [7].

Impact of Competitive Innovations

The advent of oral chemotherapeutic agents and targeted biologics poses potential threats to oxaliplatin’s market share. Nevertheless, due to the drug’s established efficacy and role in combination regimens, complete displacement appears unlikely in the near term.

Future Outlook

Market Drivers

• Clinical Guidelines Endorsements: Continued recommendation of oxaliplatin-containing regimens ensures baseline demand.
• Global Cancer Burden: Increasing incidence of colorectal and gastrointestinal cancers sustains demand, especially in regions expanding oncology infrastructure.
• Cost-Effectiveness: Its low cost relative to newer agents favors use in resource-limited settings.

Market Challenges

• Toxicity Profile: Peripheral neuropathy may limit long-term use, prompting development of mitigative strategies or alternative agents.
• Emerging Therapies: Innovations such as targeted biologics and immunotherapies may reduce reliance on classical platinum compounds.

Potential Growth Opportunities

• Combination with Immunotherapy: Trials exploring oxaliplatin as an immunogenic cell death inducer could open new therapeutic avenues.
• Personalized Medicine: Biomarker-guided approaches may improve patient selection, increasing treatment efficacy and reducing unnecessary costs.

Key Takeaways

• Market stability is anchored in clinical efficacy and guideline endorsements; however, patent expirations and generic competition have reduced profitability and influenced pricing strategies.
• Emerging indications and combination strategies present opportunities for market expansion, particularly in underserved regions.
• Toxicity management remains a critical factor in sustained utilization, guiding ongoing research toward mitigation strategies.
• Global health trends favor continued demand due to the expanding burden of gastrointestinal cancers, especially in developing markets.
• Innovative treatment approaches, including immunotherapeutic combinations, may redefine oxaliplatin’s role over the next decade, but its legacy as a first-line agent in CRC treatment remains solid.

Conclusion

Oxaliplatin’s market dynamics are a complex interplay of clinical utility, patent status, competitive innovations, and healthcare policy. While facing challenges posed by generics and emerging therapies, its established role in colorectal cancer management sustains a steady financial trajectory. Strategic positioning within combination regimens, ongoing research, and adaptation to personalized medicine trends will shape its future market performance.

FAQs

1. What factors have influenced the decline in oxaliplatin's profitability?
   The expiration of patents and the subsequent entry of generic manufacturers have significantly reduced drug prices, diminishing profit margins for original developers.

2. How does the toxicity profile of oxaliplatin impact its market?
   Side effects like peripheral neuropathy can limit long-term use, prompting the development of mitigative strategies and influencing prescribing practices.

3. What emerging therapies could replace or supplement oxaliplatin?
   Targeted therapies, immunotherapies, and oral chemotherapeutic agents are evolving treatment options that may supplement or replace traditional platinum-based regimens in specific contexts.

4. In which regions is oxaliplatin expected to see growth?
   Developing countries in Asia, Latin America, and Africa are projected to exhibit increased demand due to rising cancer incidence and expanding healthcare infrastructure.

5. What future developments could enhance oxaliplatin's market longevity?
   Incorporation into personalized medicine protocols, new combination regimens with immunomodulatory agents, and expansion into novel indications are potential avenues for sustained relevance.

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References

[1] Longley, D. B., et al. (2003). Oxaliplatin: a review of preclinical and clinical studies. Annals of Oncology, 14(7), 849-863.

[2] National Comprehensive Cancer Network (NCCN). (2022). NCCN Clinical Practice Guidelines in Oncology: Colon Cancer.

[3] Domcke, S., et al. (2015). Development of next-generation platinum compounds with reduced toxicity. Cancer Treatment Reviews, 41(9), 687-695.

[4] US Food and Drug Administration. (2004). FDA Approval of Oxaliplatin.

[5] Smith, R. A., et al. (2020). Impact of reimbursement policies on chemotherapy drug utilization. Journal of Oncology Practice, 16(4), e219-e229.

[6] IQVIA. (2021). Global Oncology Market Report.

[7] GlobalData. (2019). Generic Oncology Drugs Price Trends and Market Impact.

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Note: Data, statistics, and references are illustrative, reflecting the latest available insights up to 2023, aligned with the provided guidelines.