CARBOPLATIN - Generic Drug Details

What are the generic 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, Qilu Pharm Hainan, Sun Pharm, Teva Parenteral, Teva Pharms Usa, Teyro Labs, Cordenpharma, and Avyxa Holdings, and is included in thirty-seven 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. Ten suppliers are listed for this compound.

Summary for CARBOPLATIN

US Patents:	1
Tradenames:	3
Applicants:	26
NDAs:	37
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3,379
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
Andrew Hantel, MD	PHASE1
UNICANCER	PHASE2
Washington University School of Medicine	PHASE1

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
Fresenius Kabi Usa	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	077432-001	Sep 29, 2006		DISCN	No	No
Sandoz	CARBOPLATIN	carboplatin	INJECTABLE;INJECTION	076959-003	Mar 18, 2005		DISCN	No	No
Sun Pharm	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	077926-001	Sep 19, 2008	AP	RX	No	No

Expired US Patents for CARBOPLATIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Corden Pharma	PARAPLATIN	carboplatin	INJECTABLE;INJECTION	019880-001	Mar 3, 1989
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-003	Jul 14, 2003
Corden Pharma	PARAPLATIN	carboplatin	INJECTABLE;INJECTION	019880-002	Mar 3, 1989

Market Dynamics and Financial Trajectory for Carboplatin

Last updated: February 20, 2026

What is the current market landscape for carboplatin?

Carboplatin is a platinum-based chemotherapy drug approved for treating ovarian, lung, head and neck, and other cancers. It replaces cisplatin in many indications due to its reduced toxicity profile. The global market for carboplatin was valued at approximately $400 million in 2022, with a compound annual growth rate (CAGR) of about 4% projected through 2028[1].

How well does carboplatin sustain demand?

Demand is driven by its widespread use in oncology. Key factors include:

• Treatment Guidelines: It features in standard protocols for ovarian and lung cancers.
• Manufacturing: Off-patent status facilitates production by multiple generic companies, stabilizing supply and price.
• Combination Therapies: It is often employed with paclitaxel, bevacizumab, and other agents.

The steady adoption of carboplatin in combination regimens underpins ongoing demand, especially where alternative treatments lack superior efficacy or safety profiles.

What are the key drivers influencing market growth?

• Cancer Incidence Rates: Rising incidence, notably ovarian and non-small cell lung cancers, sustains demand.
• Technological Advances: Improvements in diagnostic accuracy and personalized medicine support targeted chemotherapy.
• Generic Competition: The expiration of patents around 2012-2014 decreased prices, prompting increased accessibility and use.
• Regulatory Environment: Approvals for novel indications, such as combination regimens in clinical trials, broaden its market.

How will economic and regulatory factors affect future growth?

Regulatory policies favor continued generic production, keeping prices low. Healthcare systems' focus on cost-effective treatments increases reliance on generic chemotherapies like carboplatin. Price pressure may affect revenue for manufacturers; however, volume growth offsets this, given its established role.

The potential introduction of biosimilars is limited, given carboplatin's small-molecule status. New formulations, such as nanoparticle carriers, are under investigation but not yet impacting market size substantially.

What is the product pipeline and innovation trajectory?

The pipeline features:

• Combination regimens in clinical trials: Aiming to improve efficacy and reduce toxicity.
• Novel delivery systems: Liposomal and nanoparticle carriers to enhance tumor targeting.
• Predictive biomarkers: To optimize patient selection, potentially expanding use.

No recent approvals for novel carboplatin formulations are on record; future growth depends on successful clinical outcomes and regulatory clearance.

What are the competitive dynamics?

Several generic manufacturers, including Sun Pharmaceutical and Teva, dominate production due to patent expirations. Price competition is intense, driving down margins. Limited product differentiation exists, making market share primarily dependent on manufacturing capacity and distribution networks.

Strategic alliances with oncology centers are common to secure consistent procurement. Brand presence is minimal due to its off-patent status, with marketers focusing on cost advantage.

How does market expansion look geographically?

North America and Europe harbor the largest markets, accounting for over 60% of sales combined in 2022. Emerging markets, such as India and China, exhibit fast growth rates (CAGR >6%) due to increasing healthcare spending and expanding oncology services.

Regulatory harmonization and price controls in emerging markets influence market penetration and profitability.

What are the financial outlooks and key risks?

Projected revenue growth remains steady at around 3-4% annually through 2028, with total sales surpassing $500 million by that time[1].

Risks include:

• Market saturation: High generic penetration limits price gains.
• Emergence of targeted therapies: Newer agents with fewer side effects may replace carboplatin in some indications.
• Regulatory changes: Stringent controls on chemotherapy use could impact demand.
• Supply chain disruptions: Raw material shortages or manufacturing issues can impair supply.

Investment in research to develop combination therapies and formulations could preserve or enhance market share.

Key Takeaways

• Carboplatin remains a vital chemotherapy agent with stable demand driven by its role in combination treatments.
• The market size is approximately $400 million (2022), with modest growth expected.
• Generic producers dominate the landscape, exerting downward price pressure.
• Geographic expansion is significant in emerging markets.
• The future relies on clinical innovations, combination regimens, and healthcare policy stability.

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FAQs

1. Will carboplatin's market decline with the advent of targeted therapies?
While targeted therapies are emerging, carboplatin maintains a foundational role alone and in combination. Its low cost and proven efficacy ensure continued demand, though some use may decline in favor of newer agents.

2. Are there any new patents or exclusivities on carboplatin?
No. As a generic, carboplatin's patent protections expired around 2012-2014, leading to widespread generic manufacturing.

3. How does pricing impact the market?
Pricing is driven downward by generic competition. This limits profit margins but ensures accessible treatment options. Volume growth offsets reduced profitability.

4. What are the major regulatory hurdles?
No major hurdles currently. However, therapeutic guidelines and national reimbursement policies significantly influence market access and volume.

5. Are biosimilars a threat to carboplatin?
Biosimilars target biologics, not small molecules like carboplatin. Biosimilar threat is minimal; generic competition remains predominant.

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References

[1] Industry analysts' reports. (2023). Market forecast for carboplatin. MarketsandMarkets.