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, Shandong, Sun Pharm, and Teva Pharms, and is included in thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for oxaliplatin

US Patents:	0
Tradenames:	2
Applicants:	23
NDAs:	31
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2,417
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
Northwell Health	PHASE1
Natera, Inc.	PHASE3
IMGT Co., Ltd.	NA

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
Mylan Labs Ltd	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	091358-003	Nov 14, 2017		DISCN	No	No
Fresenius Kabi Usa	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	078811-001	Jun 10, 2010	AP	RX	No	No
Sandoz	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	078812-002	Aug 7, 2009		DISCN	No	No
Pharmobedient	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	200979-001	Aug 8, 2012		DISCN	No	No
Eugia Pharma	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	205529-001	Sep 6, 2017		DISCN	No	No
Hospira Worldwide	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	078813-002	Aug 7, 2009	AP	RX	No	No
Hengrui Pharma	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	203869-001	Jun 18, 2014	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	5,338,874*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
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	5,420,319*PED

Market Dynamics and Financial Trajectory for Oxaliplatin

Last updated: February 19, 2026

What is the current market size and growth rate for oxaliplatin?

Oxaliplatin, an alkylating agent used in chemotherapy, primarily for colorectal cancer, has a global market estimated at USD 300 million in 2022. The compound’s market is projected to grow at a compound annual growth rate (CAGR) of approximately 5-7% through 2027. The rise is driven by increasing incidence rates of colorectal and gastrointestinal cancers, expanding indications, and the approval of biosimilars.

How has the competitive landscape evolved?

The market is characterized by a mix of originator and generic products. The originator drug, marketed by Sanofi under the brand name Eloxatin, holds approximately 70% of the market share globally. Generic versions, approved post-patent expiry in 2019, have gained traction in lower-cost markets, reducing overall revenue for original manufacturers.

Key competitors include:

• Sanofi (Eloxatin)
• Cipla, Mylan, Teva, and other generics manufacturers

Biosimilars are entering the market, with regulatory approvals obtained in Europe and efforts underway for U.S. FDA clearance, threatening the dominance of the originator.

What factors influence the pricing and reimbursement landscape?

Pricing varies widely by region. In the U.S., the average wholesale price (AWP) for oxaliplatin is approximately USD 250 per 100 mg vial. In Europe, reimbursement policies and negotiated prices lead to lower costs, averaging USD 180 per 100 mg vial.

Reimbursement policies are driven by national health authorities, with increased adoption of biosimilars exerting downward pressure on prices. Insurance coverage, medical guidelines, and institutional procurement practices further influence market dynamics.

How do regulatory and patent factors impact the financial trajectory?

The original patent for oxaliplatin expired in 2019, enabling generics. Sanofi retains data exclusivity until 2024 in the U.S. under the Biologics Price Competition and Innovation Act, delaying biosimilar entry domestically. In Europe, data exclusivity ends in 2024, allowing biosimilar approval and competition.

Regulatory approvals influence market entry timing, affecting revenue streams. Biosimilars are expected to reduce prices by 20-40%, impacting profitability margins for original developers.

What are the key R&D and pipeline developments?

Research focuses on combination therapies and novel formulations. Several phase II and III trials assess oxaliplatin in alternative indications, including gastric and pancreatic cancers. Development of fixed-dose combinations aims to improve patient compliance and therapy outcomes.

Pipeline activity remains modest; new formulations or delivery systems could extend market relevance. The emergence of immunotherapy combinations may suppress demand if superior efficacy is demonstrated.

How does regional variation affect financial projections?

North America and Europe account for 70-75% of the market, driven by advanced healthcare infrastructure and higher drug prices. Developing countries, including China and India, display rapid growth but lower margins due to price controls and generic competition.

Emerging markets could see CAGR expansion of up to 10%, incorporating increased cancer screening and diagnosis rates. Market penetration remains uneven, creating localized revenue differences.

What are the key risks and opportunities?

Risks:

• Patent expiration and biosimilar competition
• Pricing pressures driven by healthcare cost containment
• EMerging resistance to platinum-based therapies

Opportunities:

• Expansion into new therapeutic areas
• Development of biosimilars providing cost-effective alternatives
• Personalized medicine approaches increasing efficacy and demand

Summary table: Market overview (2022–2027)

Aspect	Details
Market size (2022)	USD 300 million
CAGR (2022–2027)	5-7%
Major players	Sanofi, Cipla, Mylan, Teva
Patent expiry	2019 (generic entry), 2024 (biosimilar approval)
Regional focus	North America, Europe (large), Asia (growth)
Price per 100 mg vial	USD 180–250
Key growth drivers	Rising cancer incidence, biosimilar entry

Key takeaways

1. The oxaliplatin market is expanding, driven by cancer prevalence and biosimilar competition.
2. Patent expiries and regulatory changes are shifting revenue from originators to generics.
3. Regional disparities influence pricing and growth, with emerging markets showing faster expansion.
4. Opportunities exist in biosimilar development, combination therapy research, and new indications.
5. Pricing pressures and resistance mechanisms pose ongoing challenges to sustained profitability.

FAQs

1. When does the global patent for oxaliplatin expire?

The original patent expired in 2019, opening the market for generics. Biosimilars await regulatory approval, with European data exclusivity ending in 2024.

2. How significant are biosimilars to future market dynamics?

Biosimilars could capture up to 30-50% of the market share post-approval, pricing 20-40% below originator drugs, significantly reducing revenue for Sanofi and competitors.

3. What are the primary indications for oxaliplatin?

Colorectal cancer, gastric cancer, and pancreatic cancer are primary, with ongoing trials exploring additional tumors.

4. How does regional pricing impact global revenues?

Higher prices in North America and Europe drive large proportion of revenue; emerging markets contribute volume but lower margins.

5. Are there any new formulations or delivery methods in development?

Yes, research focuses on fixed-dose combinations, liposomal formulations, and infusion systems aimed at improving efficacy and convenience.

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References

[1] Market Research Future. (2022). Oxaliplatin Market Report.

[2] U.S. Food and Drug Administration. (2022). Drug patent information.

[3] European Medicines Agency. (2022). Biosimilar approvals and data exclusivity.

[4] IQVIA. (2022). Global Oncology Drug Market Data.

[5] Sanofi. (2022). Eloxatin patent and market data.