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, Gland Pharma Ltd, Hengrui Pharma, Hospira Inc, Hospira Worldwide, Meitheal, Mylan Labs Ltd, Norvium Bioscience, Novast Labs, Qilu Pharm Hainan, Sandoz, Sun Pharm, and Teva Pharms, and is included in twenty-nine 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:	29
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	2,082
Patent Applications:	951
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
Oncotelic Inc.	Phase 2/Phase 3
State University of New York - Downstate Medical Center	Phase 1/Phase 2
Peking University	N/A

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
Chartwell Molecular	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	208523-001	Feb 10, 2017		DISCN	No	No
Teva Pharms	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	022160-002	Aug 7, 2009	AP	RX	Yes	Yes
Am Regent	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	204378-002	May 12, 2017		DISCN	No	No
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-002	Jan 31, 2005		DISCN	Yes	No
Fresenius Kabi Usa	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	078811-001	Jun 10, 2010	AP	RX	No	No
Am Regent	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	204378-001	May 12, 2017		DISCN	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	021492-002	Aug 9, 2002
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-003	Nov 17, 2006
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-002	Jan 31, 2005
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-001	Jan 31, 2005
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021492-002	Aug 9, 2002
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021492-001	Aug 9, 2002

Oxaliplatin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Oxaliplatin

Market Introduction

Oxaliplatin is a platinum-based chemotherapy drug widely used in the treatment of various cancers, including colorectal, stomach, head and neck, and pancreatic cancers. Its efficacy in combination with other chemotherapy agents has made it a crucial component in modern cancer treatment regimens[3][5].

Market Size and Growth

The global oxaliplatin market has been experiencing significant growth, driven by several key factors. As of 2023, the market was valued at USD 965.94 million and is projected to reach USD 2,065.74 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 8.81% during the forecast period (2024-2032)[1].

Driving Factors

Increasing Incidence of Cancer

The rising incidence of cancer, particularly colorectal cancer, is a major driver of the oxaliplatin market. According to projections from the American Cancer Society, the high incidence of colorectal cancer in regions like North America underscores the potential demand for oxaliplatin therapy[1].

Advances in Cancer Treatment

Recent advances in cancer treatment have led to more effective and less toxic therapies. Oxaliplatin's unique mechanism of action, which involves DNA crosslinking, makes it particularly effective in combination with other chemotherapy drugs. This has increased its demand as part of comprehensive cancer treatment plans[3].

Technological Innovations

Technological advancements, such as lyophilization (a freeze-drying technique), have enhanced the stability and shelf life of oxaliplatin, reducing the risk of side effects and making it more suitable for clinical use. Such innovations are expected to drive growth and innovation within the market[1].

Regional Market Dynamics

North America

North America is the largest market shareholder for oxaliplatin and is expected to expand substantially during the forecast period. The region's growth is driven by increased awareness of cancer treatment options and a rise in colorectal cancer cases. The American Cancer Society's projections indicate a continued high incidence of colorectal cancer, which suggests a growing demand for oxaliplatin in this region[1].

Asia-Pacific

The Asia-Pacific region is identified as the fastest-growing market for oxaliplatin. This growth can be attributed to the increasing incidence of cancer, improving healthcare infrastructure, and greater accessibility to advanced cancer treatments in this region[1].

Market Segmentation

The global oxaliplatin market is segmented based on type, application, and end-users.

By Application

The market is segmented into adjuvant treatment of stage III colon cancer, treatment of stage IV colorectal cancer, and other applications. Oxaliplatin is often used in combination with infusional fluorouracil and leucovorin for these treatments[1][2].

By Type

Oxaliplatin is available in various formulations, including mannitol, glucose solution, and lactose solution. It is administered as an intravenous infusion in dosages of 50 mg, 100 mg, or 200 mg, with a concentration of 5 mg/ml[4].

Financial Impact and Pricing

The global average selling price for a 100 mg intravenous injection of oxaliplatin ranges from USD 84 to USD 500. This pricing variability can be influenced by factors such as the formulation, the manufacturer, and regional market conditions[1].

COVID-19 Impact

The COVID-19 pandemic had a significant impact on the oxaliplatin market. While the pandemic disrupted supply chains and led to a shortage of raw materials like platinum, it also resulted in a decrease in cancer screenings. However, as the pandemic subsides, the market is expected to return to pre-pandemic growth levels, driven by the increasing demand for effective cancer treatments[3].

Challenges and Restraints

Despite the growth potential, the oxaliplatin market faces several challenges:

Side Effects and Hypersensitivity

Oxaliplatin is associated with serious side effects, including hypersensitivity reactions, peripheral sensory neuropathy, and hematological toxicities. These side effects can limit its use in certain patient populations and necessitate careful monitoring and management[2].

Affordability and Access

Ensuring fair access to oxaliplatin for all patients, regardless of financial constraints, is crucial. Measures to address affordability and accessibility will be essential in meeting the needs of an expanding patient population and ensuring equitable healthcare delivery[1].

Key Players and Competitive Landscape

The oxaliplatin market is competitive, with key players such as Sanofi (offering ELOXATIN) and other regional manufacturers like Jari Pharmaceutical and Chiatai Tianqing. The competitive landscape is characterized by ongoing innovation, new product launches, and strategic partnerships aimed at improving market share and patient outcomes[3].

Future Outlook

The future of the oxaliplatin market looks promising, driven by the increasing incidence of cancer, advances in cancer treatment, and technological innovations. As the market continues to grow, addressing challenges related to affordability, accessibility, and side effect management will be critical.

Key Takeaways

• The global oxaliplatin market is projected to grow significantly, reaching USD 2,065.74 million by 2032.
• The market is driven by the increasing incidence of cancer, particularly colorectal cancer.
• Advances in cancer treatment and technological innovations are key growth drivers.
• North America is the largest market shareholder, with the Asia-Pacific region being the fastest-growing.
• The market faces challenges related to side effects, hypersensitivity, and affordability.

Frequently Asked Questions (FAQs)

1. What is the primary use of oxaliplatin in cancer treatment? Oxaliplatin is primarily used in the treatment of colorectal cancer, both as an adjuvant therapy for stage III colon cancer and for the treatment of stage IV colorectal cancer. It is also used in combination with other chemotherapy drugs to treat various other cancers[1][2].

2. What are the common side effects associated with oxaliplatin? Common side effects include peripheral sensory neuropathy, hypersensitivity reactions, bone marrow suppression, nausea/vomiting, and cardiac complications. Serious side effects can include anaphylaxis, sepsis, and hepatic vascular disorders[2][4].

3. How does the COVID-19 pandemic impact the oxaliplatin market? The COVID-19 pandemic disrupted supply chains, led to a shortage of raw materials, and decreased cancer screenings. However, as the pandemic subsides, the market is expected to return to pre-pandemic growth levels driven by increasing demand for effective cancer treatments[3].

4. What are the key drivers of the oxaliplatin market growth? The key drivers include the increasing incidence of cancer, advances in cancer treatment, and technological innovations such as lyophilization, which enhance the stability and shelf life of oxaliplatin[1][3].

5. Which region is expected to be the fastest-growing market for oxaliplatin? The Asia-Pacific region is identified as the fastest-growing market for oxaliplatin, driven by the increasing incidence of cancer and improving healthcare infrastructure[1].

Cited Sources:

1. Straits Research: Oxaliplatin Market Size, Growth & Revenue Analysis Report | 2032
2. Pfizer Medical Information: Oxaliplatin Injection Patient Information - US
3. Business Research Insights: Oxaliplatin Market Size, Share, Growth, Forecast, 2032
4. AmeriPharma Specialty Care: Oxaliplatin Copay Assistance
5. The Insight Partners: Oxaliplatin Market Insights and Growth by 2031