Cisplatin - Generic Drug Details

What are the generic drug sources for cisplatin and what is the scope of freedom to operate?

Cisplatin is the generic ingredient in three branded drugs marketed by Accord Hlthcare, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hq Spclt Pharma, Norvium Bioscience, Pharmachemie Bv, 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:	3,887
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
EMD Serono	Phase 1
Fundación para el Progreso de la Oncología en Cantabria	Phase 2
Regeneron Pharmaceuticals	Phase 2

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-AQ	cisplatin	INJECTABLE;INJECTION	018057-003	Jul 18, 1984		DISCN	Yes	No
Fresenius Kabi Usa	CISPLATIN	cisplatin	INJECTABLE;INJECTION	074735-001	Jul 16, 1999	AP	RX	No	Yes
Hq Spclt Pharma	PLATINOL	cisplatin	INJECTABLE;INJECTION	018057-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Gland Pharma Ltd	CISPLATIN	cisplatin	INJECTABLE;INJECTION	207323-001	Mar 17, 2017	AP	RX	No	No
Accord Hlthcare	CISPLATIN	cisplatin	INJECTABLE;INJECTION	206774-001	Aug 18, 2015	AP	RX	No	No
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-004	Nov 8, 1988	AP	RX	Yes	No
Norvium Bioscience	CISPLATIN	cisplatin	INJECTABLE;INJECTION	091062-001	Apr 18, 2012		DISCN	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	5,562,925
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-002	Approved Prior to Jan 1, 1982	5,562,925
Hq Spclt Pharma	PLATINOL-AQ	cisplatin	INJECTABLE;INJECTION	018057-003	Jul 18, 1984	4,310,515
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-004	Nov 8, 1988	4,177,263
Hq Spclt Pharma	PLATINOL	cisplatin	INJECTABLE;INJECTION	018057-001	Approved Prior to Jan 1, 1982	5,562,925
Hq Spclt Pharma	PLATINOL	cisplatin	INJECTABLE;INJECTION	018057-001	Approved Prior to Jan 1, 1982	4,177,263
Hq Spclt Pharma	CISPLATIN	cisplatin	INJECTABLE;INJECTION	018057-002	Approved Prior to Jan 1, 1982	4,177,263

Cisplatin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Cisplatin

Introduction to Cisplatin

Cisplatin is a chemotherapy medication widely used in the treatment of various cancers, including testicular, ovarian, bladder, lung, cervical, and head and neck cancer. It works by inhibiting DNA replication in cancer cells, leading to their death. Despite its effectiveness, cisplatin can cause significant side effects, necessitating close monitoring by healthcare specialists[1].

Global Market Overview

The global cisplatin market is projected to grow at a compound annual growth rate (CAGR) from 2024 to 2034, reaching a substantial value in USD by the end of the forecast period. The market is driven by several key factors, including the increasing incidence of cancer, advancements in healthcare infrastructure, and the growing adoption of platinum-based therapies[1].

Regional Analysis

Asia Pacific Market

The Asia Pacific region dominates the cisplatin market, accounting for more than 47% of the global revenue. This dominance is attributed to an aging population, a growing middle class, rising cancer awareness, better access to healthcare, and significant investments in healthcare infrastructure[1].

North America Market

North America is the second-largest market for cisplatin, driven by the presence of established pharmaceutical companies, high prevalence of cancer, advanced healthcare infrastructure, and strong research and development investments[1].

Europe Market

Europe is expected to be the fastest-growing regional segment during the forecast period. Factors contributing to this growth include increasing cancer incidence, a supportive regulatory environment, the adoption of novel therapies incorporating cisplatin, and an emphasis on personalized medicine[1].

Market Segmentation

The cisplatin market can be segmented based on the type of cancer treated, application, end-user, and distribution channels.

• Type of Cancer: Lung, ovarian, testicular, and other types of cancer.
• Application: Hospitals, cancer treatment centers, and research institutes.
• End-user: Pharmaceutical wholesalers, direct sales to hospitals, and online pharmacies[1].

Key Market Players

The cisplatin market is dominated by several large pharmaceutical companies, including Pfizer, Eli Lilly and Company, David Bull Laboratories, Hospira, Bedford Pharmaceuticals, and others. These companies play a crucial role in the production, distribution, and innovation within the cisplatin market[1].

Drivers of Market Growth

Increasing Cancer Incidence

The global rise in cancer cases, particularly lung, ovarian, and testicular cancers, drives the demand for cisplatin. According to the World Health Organization (WHO), cancer is the second leading cause of death globally, with lung cancer accounting for a significant portion of these cases[3].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in the Asia Pacific region, have enhanced access to cancer treatment, thereby increasing the demand for cisplatin[1].

Combination Therapies

Cisplatin is often used in combination with other chemotherapeutic agents to improve treatment outcomes. This combination therapy approach has been shown to be more effective and cost-efficient in certain cases, such as the cisplatin/paclitaxel regimen for cervical cancer[2].

Limitations and Challenges

Side Effects and Toxicity

Cisplatin is associated with significant side effects, including nausea, vomiting, kidney impairment, hearing loss, and nerve damage. These side effects necessitate close monitoring and can limit its use in some patients[1].

Drug Shortages

Recent shortages of cisplatin have led to the use of more expensive alternative therapies, such as carboplatin and cetuximab, which have increased the overall cost of cancer treatment. This shift has resulted in a financial burden for both patients and healthcare systems[5].

Financial Trajectory

Cost Effectiveness

Studies have shown that while cisplatin alone can be costly, combination regimens like cisplatin/paclitaxel are often more cost-effective and offer better survival outcomes. For instance, the average total cost of six cycles of cisplatin/paclitaxel was $13,250, compared to $14,573 for cisplatin alone[2].

Impact of Shortages

The cisplatin shortage has led to a significant increase in treatment costs. During the shortage, the use of alternative therapies resulted in an average cost increase of over $150 per administration. Even after the shortage was resolved, the costs remained elevated, highlighting a persistent financial impact[5].

Pricing Trends and Average Selling Prices

The pricing of cisplatin and its combination therapies varies significantly. For example, the chemotherapy drug cost for six cycles of cisplatin/paclitaxel is $489, whereas for cisplatin/gemcitabine, it is $18,306. These variations in cost are influenced by the type of cancer, the regimen used, and the region[2].

Market Estimates and Forecast

The global cisplatin market is expected to grow substantially over the forecast period, driven by increasing demand and advancements in healthcare. Regional markets, particularly in Asia Pacific and Europe, are anticipated to exhibit high growth rates due to rising cancer incidence and improved healthcare infrastructure[1].

Key Mergers and Acquisitions

The market dynamics are also influenced by key mergers and acquisitions among pharmaceutical companies. These strategic moves help in expanding product portfolios, enhancing research capabilities, and improving market presence[1].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the cisplatin market. While it disrupted supply chains and led to drug shortages, it also accelerated the adoption of telehealth services and remote patient monitoring, which could benefit long-term market growth[1].

Conclusion

The cisplatin market is poised for significant growth driven by increasing cancer incidence, advancements in healthcare infrastructure, and the adoption of combination therapies. However, challenges such as drug shortages and side effects need to be addressed to ensure sustainable market growth.

Key Takeaways

• Growing Demand: Increasing cancer incidence and advancements in healthcare infrastructure drive the demand for cisplatin.
• Regional Dominance: Asia Pacific dominates the market, followed by North America and Europe.
• Combination Therapies: Cisplatin is often used in combination with other chemotherapeutic agents to improve treatment outcomes.
• Financial Impact: Drug shortages and the use of alternative therapies have increased treatment costs.
• Market Growth: The global cisplatin market is expected to grow substantially over the forecast period.

Frequently Asked Questions

1. What are the primary uses of cisplatin in cancer treatment?

Cisplatin is used to treat various cancers, including testicular, ovarian, bladder, lung, cervical, and head and neck cancer. It inhibits DNA replication in cancer cells, leading to their death[1].

2. Which region dominates the global cisplatin market?

The Asia Pacific region dominates the global cisplatin market, driven by an aging population, a growing middle class, rising cancer awareness, and better access to healthcare[1].

3. How have drug shortages impacted the use of cisplatin?

Drug shortages have led to the use of more expensive alternative therapies, such as carboplatin and cetuximab, resulting in a significant increase in treatment costs and a financial burden for patients and healthcare systems[5].

4. What are the common side effects of cisplatin?

Cisplatin is associated with significant side effects, including nausea, vomiting, kidney impairment, hearing loss, and nerve damage. These side effects necessitate close monitoring by healthcare specialists[1].

5. How does the cost of cisplatin compare to its combination therapies?

The cost of cisplatin varies significantly depending on the regimen used. For example, the average total cost of six cycles of cisplatin/paclitaxel is $13,250, whereas for cisplatin/gemcitabine, it is $33,559. Cisplatin/paclitaxel is often more cost-effective and offers better survival outcomes[2].

Sources:

1. We Market Research - Cisplatin Market Growth, Share, Trends 2024-2034
2. PubMed - An economic analysis of cisplatin alone versus cisplatin doublets in ...
3. BioSpace - Platinum-based Drugs Market: Cisplatin segment held the largest ...
4. Polaris Market Research - Platinum Based Cancer Drugs Market Size - Global Industry Report ...
5. Cancer Network - Cisplatin Shortage Shifted Chemo Utilization to Costlier Therapies ...