Carboplatin - Generic Drug Details

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

Carboplatin is the generic ingredient in three branded drugs marketed by Cipla Ltd, Fresenius Kabi Usa, Hikma, Hospira, Natco Pharma Usa, Pliva, Sandoz, Watson Labs Teva, Corden Pharma, Accord Hlthcare, Actavis Totowa, Epic Pharma Llc, Eugia Pharma, Gland, Meitheal, Novast Labs, Pharmachemie Bv, Pharmobedient, Pliva Lachema, Sun Pharm, Teva Parenteral, Teva Pharms Usa, Teyro Labs, Cordenpharma, and Avyxa Holdings, and is included in thirty-six NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for carboplatin. Eleven suppliers are listed for this compound.

Summary for carboplatin

US Patents:	1
Tradenames:	3
Applicants:	25
NDAs:	36
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3,339
Patent Applications:	7,515
Drug Prices:	Drug price trends for carboplatin
What excipients (inactive ingredients) are in carboplatin?	carboplatin excipients list
DailyMed Link:	carboplatin at DailyMed

See drug prices for carboplatin

Recent Clinical Trials for carboplatin

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

Sponsor	Phase
ModernaTX, Inc.	PHASE2
Janssen Medical Affairs	PHASE2
PrECOG, LLC.	PHASE2

See all carboplatin clinical trials

Pharmacology for carboplatin

Drug Class

Platinum-based Drug

Medical Subject Heading (MeSH) Categories for carboplatin

Antineoplastic Agents

Cross-Linking Reagents

Anatomical Therapeutic Chemical (ATC) Classes for carboplatin

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

US Patents and Regulatory Information for carboplatin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teyro Labs	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	077861-001	Jan 18, 2007	AP	RX	No	No
Fresenius Kabi Usa	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	077266-002	Feb 15, 2006		DISCN	No	No
Gland	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	207324-001	Feb 15, 2017	AP	RX	No	No
Pharmobedient	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	091063-003	Nov 9, 2011		DISCN	No	No
Sun Pharm	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	077926-003	Sep 19, 2008	AP	RX	No	No

Expired US Patents for carboplatin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-002	Jul 14, 2003	4,657,927*PED
Corden Pharma	PARAPLATIN	carboplatin	INJECTABLE;INJECTION	019880-001	Mar 3, 1989	4,657,927*PED
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-004	Jan 15, 2004	4,657,927*PED
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-003	Jul 14, 2003	4,657,927*PED
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-001	Jul 14, 2003	4,657,927*PED

Market Dynamics and Financial Trajectory for Carboplatin

Last updated: July 27, 2025

Introduction

Carboplatin, a platinum-based chemotherapeutic agent, has maintained a pivotal position in oncology since its FDA approval in 1989. As a cornerstone treatment for ovarian, lung, and other cancers, carboplatin’s market presence remains robust, driven by its efficacy, safety profile, and evolving treatment guidelines. This analysis delineates current market dynamics and forecasts the financial trajectory of carboplatin amid shifting therapeutic landscapes, regulatory factors, and competitive pressures.

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Market Overview

Therapeutic Use and Clinical Significance

Carboplatin is primarily indicated for ovarian, non-small cell lung (NSCLC), and head and neck cancers [1]. Its mechanism involves forming DNA crosslinks, inducing apoptosis. Compared to cisplatin, it offers comparable efficacy with a more tolerable side-effect profile, notably reduced nephrotoxicity and ototoxicity [2].

Market Size and Growth Drivers

The global chemotherapy market, valued at approximately USD 16 billion in 2022, projects steady growth, with carboplatin constituting a significant segment. The central drivers include:

• Rising cancer prevalence: According to the WHO, cancer incidences are projected to reach 28.4 million new cases annually by 2040, bolstering demand for chemotherapeutics [3].

• Expanding indications: Ongoing clinical trials exploring carboplatin in new combinations and indications, such as triple-negative breast cancer, extend its potential market.

• Increased adoption in developing economies: Growing healthcare infrastructure and cancer screening programs expand market reach.

Key Market Participants

Major pharmaceutical companies manufacturing carboplatin include:

• Mundipharma (marketed as Paraplatin in the US)
• Hospira (Pfizer)
• Sun Pharmaceutical Industries
• Jiangsu Hengrui Medicine

Generic versions dominate the market, leading to pricing pressures and commoditization.

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Market Dynamics

Regulatory Landscape

Regulatory authorities, including FDA and EMA, continuously oversee manufacturing standards, indications, and safety monitoring. Expansion of approved indications, driven by clinical research, enhances market scope. Conversely, patent expirations and entry of generics have intensified price competition, reducing revenue potential for branded products.

Pricing and Reimbursement Environment

Generic proliferation has led to significant price erosion. For example, in the US, the average wholesale price (AWP) for carboplatin has declined by approximately 40-50% over the past decade [4]. Reimbursement policies, especially in emerging markets, influence accessibility and volume sales.

Competitive and Technological Factors

While carboplatin remains a mainstay, novel therapies—immunotherapies and targeted agents—are challenging its dominance:

• Immunotherapy combinations: Pembrolizumab and nivolumab, when combined with chemotherapy, demonstrate superior survival benefits in certain cancers, potentially reducing carboplatin’s market share.

• Alternative platinum agents: Nedaplatin and oxaliplatin are occasionally used as substitutes, guided by specific patient factors.

Manufacturing and Supply Chain Considerations

Global supply chain disruptions, notably during the COVID-19 pandemic, have underscored the importance of robust manufacturing and distribution channels. Many manufacturers have invested in strategic sourcing to mitigate risks.

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Financial Trajectory

Historical Revenue Trends

Leading market players reported revenues ranging from USD 100–300 million annually for carboplatin. For instance, in 2021, Pfizer’s global sales of injectable chemotherapy agents, including carboplatin, approached USD 2 billion, with carboplatin accounting for approximately 10–15% [5].

Projection to 2030

Analysts forecast the carboplatin market will experience a compound annual growth rate (CAGR) of approximately 2-3% from 2023 to 2030, influenced by:

• Market saturation in established territories, potentially restraining growth.
• Emerging markets offering the highest growth potential, with CAGR reaching 5-6%, driven by increasing cancer incidence and improving healthcare access.
• Pricing pressures and generic competition likely to compress profit margins, especially in mature markets.

Impact of Innovation and Biosimilars

The advent of biosimilars for platinum-based drugs and innovative therapies may further influence financial outcomes. While carboplatin biosimilars are not yet available, regulatory acceptance could accelerate price declines.

Strategic Considerations

Pharmaceutical companies may pursue:

• Pipeline development: Combining carboplatin with immunotherapies or targeted agents to sustain clinical relevance.
• Market diversification: Entering new indications or geographies.
• Manufacturing efficiencies: To offset declining prices.

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Key Market Challenges and Opportunities

Challenges

• Competition from newer therapies with superior efficacy.
• Price erosion due to generics.
• Regulatory hurdles for new indications or formulations.
• Changing clinical guidelines, favoring targeted therapies and immunotherapies.

Opportunities

• Combination therapies: Leveraging carboplatin in immuno-oncology protocols.
• Personalized medicine: Targeting biomarker-driven patient cohorts.
• Regional expansion: Focus on populous, underserved markets.
• Developing formulations: Such as fixed-dose combinations or nanoparticle delivery systems to improve efficacy.

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Conclusion

Carboplatin’s market remains integral to oncology, anchored by decades of clinical utility and a broad treatment base. However, its financial trajectory faces headwinds from price competition, evolving therapeutic standards, and emerging alternatives. Strategic positioning—through pipeline innovation, regional expansion, and combination therapy development—will be crucial for sustaining revenues. Stakeholders must monitor regulatory developments, market dynamics, and technological innovations to adapt proactively.

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Key Takeaways

• The global carboplatin market is stable but mature, with moderate growth primarily driven by emerging markets and expanding indications.
• Price erosion due to generics emphasizes the importance of optimizing manufacturing efficiencies and diversifying application areas.
• Future growth hinges on integrating carboplatin into combination regimens, especially with immunotherapies, and targeting emerging markets.
• Competition from novel therapeutics and biosimilars will pressure margins, prompting innovation in formulations and delivery.
• Strategic collaborations and ongoing clinical trials are vital for maintaining market relevance amidst evolving oncology treatment paradigms.

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FAQs

1. How has the patent expiration impacted carboplatin’s market?
Patent expirations led to widespread generic availability, significantly reducing prices and altering profit dynamics. While volume sales remain stable due to its clinical utility, profit margins have declined, pushing manufacturers to innovate and diversify offerings.

2. What new indications could expand carboplatin’s market?
Emerging evidence suggests potential in combination with immunotherapies for lung and gynecologic cancers, among others. Clinical trials exploring carboplatin in novel settings could facilitate regulatory approvals, broadening its application.

3. How do competitors impact the market trajectory?
Nivitolumab, pembrolizumab, and other immunotherapies pose competition, especially when used alone or in combination. Their superior efficacy and favorable side-effect profiles shift prescribing patterns, potentially restricting carboplatin’s share.

4. What regional market potentials exist for carboplatin?
Emerging markets in Asia, Africa, and Latin America offer substantial growth prospects due to rising cancer burdens and improving healthcare infrastructure. Local manufacturing and strategic partnerships can enhance market access.

5. What are the future innovation pathways for carboplatin?
Innovations include developing formulation improvements (e.g., nanoencapsulation), creating fixed-dose combinations, and exploring biomarker-guided therapy to improve efficacy and reduce toxicity.

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References

[1] WHO. "Cancer Fact Sheets." 2022.
[2] Lippman, M. E., & Satcher, C. "Chemotherapy Effectiveness and Toxicity Profiles." Cancer Journal, 2015.
[3] WHO. "Cancer in 2030: Global Epidemiology." 2021.
[4] IQVIA. "Pharmaceutical Pricing Trends." 2022.
[5] Pfizer Annual Reports. 2021.