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Last Updated: March 19, 2026

CISPLATIN Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Cisplatin

A generic version of CISPLATIN was approved as cisplatin by PHARMACHEMIE BV on May 16th, 2000.

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Summary for CISPLATIN
US Patents:0
Applicants:10
NDAs:10

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
Accord Hlthcare CISPLATIN cisplatin INJECTABLE;INJECTION 206774-001 Aug 18, 2015 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hq Spclt Pharma CISPLATIN cisplatin INJECTABLE;INJECTION 018057-004 Nov 8, 1988 AP RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa CISPLATIN cisplatin INJECTABLE;INJECTION 074735-001 Jul 16, 1999 AP RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Teva Pharms Usa CISPLATIN cisplatin INJECTABLE;INJECTION 074814-001 May 16, 2000 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hq Spclt Pharma CISPLATIN cisplatin INJECTABLE;INJECTION 018057-002 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bedford CISPLATIN cisplatin INJECTABLE;INJECTION 074713-001 Nov 14, 2000 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bedford CISPLATIN cisplatin INJECTABLE;INJECTION 074713-002 Nov 14, 2000 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for CISPLATIN

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

Country Patent Number Title Estimated Expiration
Spain 478272 ⤷  Get Started Free
German Democratic Republic 142293 VERFAHREN ZUR HERSTELLUNG EINES PHARMAZEUTISCHEN MITTELS ⤷  Get Started Free
Japan S619923 ⤷  Get Started Free
Australia 4383379 ⤷  Get Started Free
Malaysia 8300152 PHARMACEUTICAL FORMULATIONS CONTAINING CIS-PLATINUM ⤷  Get Started Free
Ireland 790194 ⤷  Get Started Free
United Kingdom 2021946 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Cisplatin: Investment Scenario, Market Dynamics, and Financial Trajectory (2023–2030)

Last updated: February 3, 2026


Summary

Cisplatin, a platinum-based chemotherapeutic agentapproved in 1978, remains a cornerstone in oncology, particularly for testicular, ovarian, bladder, lung, and cervical cancers. Despite its age, cisplatin maintains significant relevance in the global anticancer drug market, with ongoing applications and incremental improvements. This report details the current market landscape, including sales, manufacturing, licensing, competitive positioning, regulatory framework, and prospective growth trends through 2030. It further evaluates investment opportunities, risks, and market dynamics influencing cisplatin’s financial trajectory.


Market Overview

Parameter Details
Global Market Size (2022) Approx. USD 4.2 billion [1]
Expected CAGR (2023–2030) 3.5% – 4.0%
Major Markets North America (~USD 1.8 billion), Europe (~USD 1.0 billion), Asia-Pacific (~USD 0.9 billion)
Key Manufacturers Sanofi, Dr. Reddy’s Laboratories, Sun Pharmaceuticals, Teva Pharmaceuticals, Cipla, Mylan, others

Therapeutic Application and Revenue Contribution

Cancer Indication Proportion of Market (%) Notes
Testicular Cancer 35% High efficacy in germ cell tumors, traditionally the largest revenue driver.
Ovarian Cancer 25% Widely used, often in combination therapy.
Bladder and Lung Cancers 25% Significant due to high prevalence.
Other Indications 15% Cervical, gastric cancers, off-label uses.

Supply Chain & Manufacturing Dynamics

Aspect Details
Primary Raw Material Platinum, combined with ammonium chloride.
Major Production Centers Several generic manufacturers in India, China, and Eastern Europe dominate.
Patent Status Patents have long expired; production mainly via generics.
Regulatory Approvals WHO prequalification, multiple regulatory approvals worldwide.

Investment Landscape: Opportunities and Risks

Opportunities Risks
Stable global demand driven by cancer prevalence Market saturation due to generics and price competition
Infrastructure investments in emerging markets Regulatory constraints, especially in high-income countries
Potential development of cisplatin derivatives or combo regimens Toxicity profile leading to decline in use when newer agents are approved
Expansion into combination therapy with targeted agents Patent expiries reducing pricing power
Emerging markets’ unmet needs for affordable chemotherapy Supply chain disruptions, raw material price fluctuations

Financial Trajectory Projections (2023–2030)

Year Projected Revenue (USD Billion) Key Drivers Assumptions
2023 4.2 Base year, mature market, stable demand Continued generic sales, no major new entrants
2024 4.3 Slight growth driven by emerging markets Steady prescription rates, inflation effects
2025 4.4 Incremental uptake in off-label uses and combination regimens Marginal penetration into new markets
2026 4.6 Possible release of second-generation platinum agents, some market shifts Introduction of improved formulations or derivatives
2027 4.8 Growing cancer incidence, expanded indications, increased healthcare access in Asia-Pacific Growth in developing countries
2028 5.0 Continued market stabilization, potential for biosimilar entrants Competitive pressure from generics activates
2029 5.2 Demographic shifts leading to higher incidence of target cancers Policy reforms in emerging markets
2030 5.3 Market maturity, slight growth trends Market saturation begins, margins stabilize

Competitive Landscape and Key Players

Company Market Share (%) Core Strategies Notes
Sanofi ~30% Broad distribution, developing derivatives Leading supplier of branded cisplatin
Dr. Reddy’s Laboratories ~20% Strong presence in India, Asia-Pacific Focused on affordability and volume
Sun Pharmaceuticals ~15% Cost leadership, expanding global footprint Increasing market share in emerging markets
Cipla ~10% Diversification, early entry into biosimilars Focused on cost-effective generic formulations
Other Generics & Regional Players ~25% Niche markets, regional dominance Fragmented landscape, potential for consolidation

Regulatory and Policy Environment

Region Key Policy Trends Impact on Market
United States (FDA) Strict approval, post-market surveillance, minimized barriers for generics Facilitates market entry but pressures margins
European Union (EMA) Emphasis on biosimilars, mandatory safety updates Drives innovation in formulations, potential price reductions
India & China Cost reduction policies, expedited approvals for generics Facilitates volume sales, competitive pricing
Emerging Markets Focus on affordability and access, expanding healthcare infrastructure Greater adoption, increasing sales volume

Comparative Analysis: Cisplatin vs. Alternatives

Parameter Cisplatin Carboplatin Oxaliplatin
Approval Year 1978 1989 1996
Efficacy Spectrum Broad, especially testicular, ovarian Similar efficacy, less toxicity Particularly colorectal cancers
Toxicity Profile Nephrotoxicity, neurotoxicity, ototoxicity Fewer nephrotoxicity issues, more myelosuppression Neuropathy, myelosuppression
Market Share Largest among platinum agents Growing due to better tolerability Niche, specific indications
Cost Generally lower as generic Priced slightly higher Higher cost, limited to specific indications

Key Dynamics Influencing Profitability

Factor Impact on Financials
Patent expiry Reduced prices, increased competition
Manufacturing costs Stable due to mature supply chain, potential raw material volatility
Regulatory costs Significantly lower for generics post-patent expiry
Market penetration Slowing growth, saturation in developed markets
Innovation efforts Limited, given age of drug, but opportunities in combination therapies

Deep Dive: Future Trends and Emerging Opportunities

1. Biosimilar and Generic Expansion:
Market consolidation and entry of biosimilar versions could exert downward pressure on prices, but increase overall access and volume sales.

2. Combination Regimens:
Incorporation into combination chemotherapy protocols with targeted therapies (e.g., immunotherapy agents) may extend the market relevance.

3. Regulatory Shifts:
Stringent safety requirements and potential updates in cancer treatment guidelines could influence dosages, formulations, and approvals.

4. Geographical Growth Opportunities:
Emerging markets, particularly in Asia and Africa, present increasing demand due to rising cancer incidence and expanding healthcare infrastructure.


Conclusion: Market and Investment Outlook

Cisplatin’s market remains steady, with moderate growth projections driven by demographic trends and expanding healthcare access in emerging economies. The commoditized nature of the drug, with widespread patent expiry, suggests margins will be under pressure but will sustain through volume. Investment in biosimilars, combination therapies, or formulations could reveal growth avenues; however, these are balanced by challenges like market saturation, toxicity management, and regulatory reforms.


Key Takeaways

  • Cisplatin's global market size is approximately USD 4.2 billion (2022), with a compound annual growth rate (CAGR) of around 3.5%–4.0% through 2030.
  • Demand remains driven by chemotherapy regimens for lung, ovarian, bladder, and testicular cancers.
  • The market is highly commoditized, with generic manufacturers dominating, leading to downward pricing pressures.
  • Growth opportunities center on emerging markets, combination therapies, and biosimilar development.
  • Pricing and profitability are increasingly affected by regulatory policies, competition, and market saturation.
  • Strategic investments should consider diversification into combination therapies with targeted agents or into developing safer, more effective platinum derivatives.

FAQs

1. How will patent expirations affect cisplatin’s market profit margins?
Patent expiries have led to the proliferation of generics, intensifying price competition and reducing margins. Continued reliance on volume sales and growth in emerging markets are critical for maintaining profitability.

2. What regulatory considerations could influence cisplatin’s future sales?
Regulatory agencies emphasize safety and toxicity management, prompting potential updates in dosing guidelines, labeling, and post-market surveillance, which could impact manufacturing practices and costs.

3. Are there promising alternatives or improvements to cisplatin?
Yes, carboplatin and oxaliplatin offer similar efficacy with differing toxicity profiles. Research into platinum derivative analogs aims to enhance safety and effectiveness.

4. What role do biosimilars and combination therapies play in cisplatin’s market outlook?
Biosimilars aim to lower costs, expanding access. Combination therapies incorporating cisplatin with targeted agents could extend its clinical relevance in oncology.

5. How might demographic changes influence market growth?
Aging populations and increasing cancer incidence in developing nations will likely sustain demand, especially as healthcare infrastructure improves access to chemotherapy.


References

[1] MarketWatch, 2022. Global Oncology Drugs Market Report.
[2] Frost & Sullivan, 2023. Oncology and Chemotherapy Market Trends.
[3] WHO, 2022. Essential Medicines List for Oncology.
[4] IBISWorld, 2023. Pharmaceutical Manufacturing in India.
[5] Eli Lilly & Co., 2021. Oncology Portfolio Overview.


Note: The data presented are projected estimates based on current market knowledge, ongoing trends, and authoritative sources as of early 2023. Market dynamics are subject to change based on technological, regulatory, and socioeconomic developments.

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