CISPLATIN - Generic Drug Details

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

Cisplatin is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Bedford, Fresenius Kabi Usa, Gland, Hikma, Hq Spclt Pharma, Pharmachemie Bv, Pharmobedient, Qilu, and Teva Pharms Usa, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for cisplatin. Ten suppliers are listed for this compound.

Summary for CISPLATIN

US Patents:	0
Tradenames:	3
Applicants:	10
NDAs:	10
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	10
Clinical Trials:	4,283
Drug Prices:	Drug price trends for CISPLATIN
What excipients (inactive ingredients) are in CISPLATIN?	CISPLATIN excipients list
DailyMed Link:	CISPLATIN at DailyMed

See drug prices for CISPLATIN

Recent Clinical Trials for CISPLATIN

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

Sponsor	Phase
National Cancer Institute (NCI)	PHASE3
Massachusetts General Hospital	PHASE2
City of Hope Medical Center	PHASE1

See all CISPLATIN clinical trials

Pharmacology for CISPLATIN

Drug Class

Platinum-based Drug

Medical Subject Heading (MeSH) Categories for CISPLATIN

Antineoplastic Agents

Cross-Linking Reagents

Radiation-Sensitizing Agents

Anatomical Therapeutic Chemical (ATC) Classes for CISPLATIN

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

US Patents and Regulatory Information for CISPLATIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hq Spclt Pharma	PLATINOL	cisplatin	INJECTABLE;INJECTION	018057-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Qilu	CISPLATIN	cisplatin	INJECTABLE;INJECTION	218868-001	May 10, 2024	AP	RX	No	No
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Accord Hlthcare	CISPLATIN	cisplatin	INJECTABLE;INJECTION	206774-001	Aug 18, 2015	AP	RX	No	No

Expired US Patents for CISPLATIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hq Spclt Pharma	PLATINOL-AQ	cisplatin	INJECTABLE;INJECTION	018057-003	Jul 18, 1984
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-002	Approved Prior to Jan 1, 1982
Hq Spclt Pharma	PLATINOL-AQ	cisplatin	INJECTABLE;INJECTION	018057-003	Jul 18, 1984
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-004	Nov 8, 1988

Market Dynamics and Financial Trajectory for Cisplatin

Last updated: November 22, 2025

Introduction

Cisplatin, chemically known as cis-diamminedichloroplatinum(II), stands as a cornerstone in the chemotherapy landscape, primarily employed in treating various solid tumors such as ovarian, testicular, bladder, and lung cancers. Since its discovery in the 1960s, cisplatin has revolutionized oncological treatment protocols, establishing a benchmark against which new chemotherapeutic agents are evaluated. The drug’s market participation, driven by its established efficacy, faces dynamic shifts influenced by emerging therapies, regulatory landscapes, and global health trends.

This article examines the current market environment for cisplatin, addressing key factors steering its growth, challenges impeding its expansion, and projected financial trajectories over the coming decade.

Market Overview

Historical Market Performance

Cisplatin generated approximately USD 2.2 billion globally in 2022, with a compound annual growth rate (CAGR) estimated at around 3-4% over the past five years (2021–2026 projections). Its predominant markets include North America, Europe, and parts of Asia-Pacific, where standard-of-care protocols incorporate cisplatin as a first-line agent for specific cancers.

Market Drivers

• Established Efficacy: Decades of clinical validation cement cisplatin as a frontline treatment, especially in testicular, ovarian, and lung cancers (1).
• Generic Availability: Post-patent expiration, generics dominate the market, making the drug more accessible and increasing volume sales.
• Global Cancer Incidence Rates: Rising cancer cases globally, notably in Asia-Pacific countries, bolster demand for cisplatin.
• Regulatory Approvals and Expansion: Ongoing approvals for new indications expand the potential customer base.

Market Challenges

• Toxicity Profiles: Adverse effects such as nephrotoxicity, ototoxicity, and myelosuppression limit its use and patient compliance.
• Emerging Resistance: Acquired resistance diminishes efficacy over time, leading to treatment failure.
• Competition from Targeted and Immunotherapies: The expansion of targeted agents (e.g., EGFR inhibitors) and immune checkpoint inhibitors (e.g., pembrolizumab) alters first-line treatment preferences, particularly in non-small-cell lung cancer (2).
• Environmental and Manufacturing Concerns: Metal-based drugs face scrutiny for environmental impact during production and disposal.

Emerging Trends

• Combination Therapy Usage: Cisplatin’s integration into combination regimens aims to enhance efficacy and reduce resistance.
• Personalized Medicine Initiatives: Biomarker development allows for tailored therapies, potentially reducing reliance on cisplatin in certain populations.
• Novel Formulations: Liposomal or nanoparticle-based cisplatin formulations aim to mitigate toxicity and improve targeting.

Market Segmentation

By Application

• Testicular Cancer: The primary indication, with near 100% responsiveness in early stages.
• Ovarian Cancer: Often combined with paclitaxel; significant revenue contributor.
• Lung Cancer: Used in small cell and non-small cell subtypes; competing with targeted therapies.
• Bladder, Cervical, and Other Cancers: Secondary markets with variable adoption.

By Geography

• North America: Largest market share, supported by high cancer prevalence and healthcare infrastructure.
• Europe: Significant due to well-established oncology protocols.
• Asia-Pacific: Rapidly growing due to escalating cancer incidence, improved healthcare access, and generic availability.
• Rest of World: Market expansion hindered by regulatory hurdles and healthcare resource limitations.

Financial Trajectory and Future Outlook

Short to Medium Term

The global cisplatin market is anticipated to sustain moderate growth, driven predominantly by emerging economies and expanding indications for existing uses. Expedited approvals for combination regimens and supportive care drugs are expected to enhance overall sales volume.

Long-Term Projections (2027–2032)

• Market Stabilization: Market growth may plateau as newer therapies gain prominence, especially immune-based treatments.
• Innovation Impact: Development of cisplatin analogs with reduced toxicity, such as carboplatin and oxaliplatin, could diminish cisplatin’s market share.
• Regulatory and Environmental Factors: Stricter manufacturing and disposal regulations could impact profit margins.

An approximate annual revenue of USD 2.0–2.5 billion is projected by 2030, assuming continued usage in combination therapies and expanding markets in emerging economies (3).

Key Factors Influencing Financial Trends

• Patent-Cliff Dynamics: Current generics ensure price competition; any future patent protections or exclusivity rights for formulations could temporarily boost revenues.
• Drug Resistance Patterns: Growing resistance rates may lead to decreased monotherapy efficacy, compelling shifts towards alternative treatments.
• Healthcare Policy and Reimbursement: Policy reforms favoring targeted therapeutics could constrict cisplatin’s utilization.

Competitive Landscape

Major pharmaceutical players manufacturing cisplatin include Baxter International, Pfizer, Fresenius Kabi, and Sandoz. Generic manufacturers dominate due to patent expiration, intensifying price competition. Meanwhile, innovative formulations and combination therapies driven by biotech firms could reshape competitive dynamics.

Conclusion

Cisplatin remains a foundational chemotherapeutic agent, with a resilient market maintained by its proven efficacy and broad global application. However, market growth faces headwinds from toxicity concerns, rising competition from targeted therapies, and evolving treatment paradigms. While the drug’s financial trajectory will likely remain stable over the next five years, the long-term outlook necessitates monitoring innovations in drug delivery, emerging resistance patterns, and regulatory changes.

Key Takeaways

• The global cisplatin market is characterized by steady, moderate growth driven by high-incidence cancers and generic proliferation.
• Emerging therapies and resistance patterns are critical factors potentially curbing future market expansion.
• Ongoing innovations—like targeted formulations to mitigate toxicity—offer potential avenues for maintaining relevance.
• Asia-Pacific and emerging economies present significant growth opportunities owing to increasing cancer burdens.
• Strategic partnerships and research into combination regimens will be essential for pharma stakeholders aiming to sustain profitability.

FAQs

1. How does cisplatin compare with newer platinum-based drugs?
Cisplatin’s efficacy remains unmatched in certain indications, but drugs like carboplatin and oxaliplatin offer improved toxicity profiles, influencing their preferred status in some treatments.

2. What are the primary adverse effects limiting cisplatin use?
Nephrotoxicity, ototoxicity, neurotoxicity, and myelosuppression are significant adverse effects, necessitating careful patient monitoring and supportive care.

3. Is the cisplatin market expected to grow or decline in the next decade?
While overall demand is expected to remain steady, growth may plateau due to competition and emerging therapies. However, expanding use in combination regimens and emerging markets could sustain income levels.

4. How do environmental concerns affect cisplatin manufacturing?
Metal-based drugs like cisplatin face increased scrutiny over environmental impact during production and disposal, potentially leading to stricter regulatory standards and increased manufacturing costs.

5. What role do biosimilars and generics play in cisplatin’s market?
Generics dominate due to patent expirations, leading to competitive pricing and increased access but also exerting pressure on profit margins for original manufacturers.

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Sources:
[1] World Health Organization. "Cancer Fact Sheet," 2022.
[2] National Cancer Institute. "Cisplatin and Other Platinum-Containing Drugs," 2021.
[3] MarketResearch.com. "Global Chemotherapy Drug Market Forecast," 2023.