Carboplatin - Generic Drug Details

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

Carboplatin is the generic ingredient in two 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 Pharma Ltd, Meitheal, Norvium Bioscience, Novast Labs, Pharmachemie Bv, Pliva Lachema, Sun Pharm, Teva Parenteral, Teva Pharms Usa, Teyro Labs, and Cordenpharma, and is included in thirty-five NDAs. 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:	0
Tradenames:	2
Applicants:	24
NDAs:	35
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	2,994
Patent Applications:	265
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
EMD Serono	Phase 1
Istituto Oncologico Veneto IRCCS	Phase 2
Yale University	Phase 1

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;INJECTION	076235-003	Oct 14, 2004		DISCN	No	No
Sandoz	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	078280-002	May 8, 2008	AP	RX	No	No
Actavis Totowa	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	078732-002	Feb 6, 2012		DISCN	No	No
Gland Pharma Ltd	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	207324-002	Feb 15, 2017	AP	RX	No	No
Sun Pharm	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	077926-002	Sep 19, 2008	AP	RX	No	No
Eugia Pharma	CARBOPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	205487-003	Mar 28, 2016	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	020452-004	Jan 15, 2004	4,657,927*PED
Corden Pharma	PARAPLATIN	carboplatin	INJECTABLE;INJECTION	019880-001	Mar 3, 1989	4,657,927*PED
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-003	Jul 14, 2003	4,657,927*PED
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-002	Jul 14, 2003	4,657,927*PED
Cordenpharma	PARAPLATIN	carboplatin	INJECTABLE;INTRAVENOUS	020452-001	Jul 14, 2003	4,657,927*PED
Corden Pharma	PARAPLATIN	carboplatin	INJECTABLE;INJECTION	019880-002	Mar 3, 1989	4,657,927*PED

Carboplatin Market Analysis and Financial Projection Experimental

Carboplatin Market Dynamics and Financial Trajectory

Introduction to Carboplatin

Carboplatin is a platinum-based chemotherapy drug widely used in the treatment of various cancers, including ovarian, lung, and bladder cancers. It works by binding to DNA in cancer cells, forming cross-links that inhibit replication and transcription, ultimately triggering apoptosis or programmed cell death[4].

Market Size and Growth Projections

The carboplatin market has been experiencing significant growth, driven by several key factors. As of 2023, the market size was valued at USD 1.5 billion and is projected to reach USD 2.5 billion by 2031, growing at a compound annual growth rate (CAGR) of 6.2% from 2024 to 2031[1].

Drivers of Market Growth

Rising Global Cancer Burden

The increasing prevalence of cancer globally is a major driver of the carboplatin market. As cancer incidence rates rise, the demand for effective chemotherapy options like carboplatin increases, contributing to market expansion[1][4].

Improvements in Oncology Research

Advancements in oncology research, including new drug combinations and formulations, are enhancing the efficacy and patient outcomes of carboplatin-based therapies. This ongoing research is expanding the therapeutic applications of carboplatin, making it a cornerstone in cancer treatment[1][4].

Growing Geriatric Population and Lifestyle Changes

The growing geriatric population and changes in lifestyle are contributing to higher cancer incidences, which in turn drive the demand for carboplatin. As the population ages and lifestyle factors such as smoking and obesity increase, the need for effective cancer treatments rises[1].

Regulatory Approvals and New Indications

Regulatory approvals for new indications and formulations of carboplatin are further expanding its therapeutic applications. This expansion into new treatment areas is a significant factor in the market's growth[1].

Partnerships and Innovation

Strategic partnerships between pharmaceutical companies and research institutions are driving innovation in oncology treatments. These collaborations support ongoing improvements in carboplatin-based therapies, making them more effective and patient-friendly[1][4].

Regional Market Dynamics

North America

North America currently holds a dominant share of the carboplatin market, primarily due to advanced healthcare infrastructure and high expenditure on oncology treatments. The region's strong healthcare system and high demand for cancer therapies make it a key market for carboplatin[4].

Asia-Pacific

The Asia-Pacific region is rapidly emerging as a significant player in the carboplatin market. Countries like India and China are investing heavily in cancer care, leading to increased demand for effective chemotherapeutic agents. Improved healthcare access and rising disposable incomes in this region are driving market growth[4].

Cost-Effectiveness and Treatment Outcomes

Carboplatin is often evaluated for its cost-effectiveness in treatment sequences. Studies have shown that sequences starting with carboplatin are generally less costly while maintaining comparable or superior quality-adjusted life years (QALYs) compared to other treatment sequences. For instance, probabilistic sensitivity analyses indicate that carboplatin-based sequences are the least costly at all levels of QALY gain, although there are smaller differences between sequences starting with carboplatin and those starting with other agents like CAPE (capecitabine)[2].

Challenges: Drug Shortages

Despite the growing demand and market expansion, the carboplatin market faces significant challenges, particularly in the form of drug shortages. A recent shortage of carboplatin and cisplatin in the U.S. was triggered by an FDA inspection of an Indian manufacturing facility, which halted production due to concerning findings. This shortage has impacted nearly all responding institutions, with 93% of centers experiencing a carboplatin shortage[5].

Impact of Shortages on Treatment

The shortage of carboplatin and cisplatin has made it difficult for clinicians to provide patients with first-line or second-line treatment regimens. This shortage highlights the need for more resilient supply chains and diversified manufacturing sources to ensure consistent availability of critical chemotherapy agents[5].

Future Trends and Opportunities

Combination Therapies

Recent research has highlighted the potential of carboplatin in combination therapies, particularly when paired with immunotherapy and targeted therapies. These combinations are expected to enhance the efficacy of carboplatin, leading to improved patient outcomes and expanded applications in cancer treatment protocols[4].

Personalized Medicine

The increasing emphasis on personalized medicine offers a pathway for developing targeted carboplatin therapies tailored to individual patient needs. This approach is expected to improve treatment outcomes and patient quality of life, presenting significant opportunities for pharmaceutical companies and investors[4].

Strategic Partnerships

Strategic partnerships between pharmaceutical companies and research institutions will continue to drive innovation in carboplatin-based therapies. These collaborations are crucial for uncovering new applications and formulations, thereby sustaining market growth[1][4].

Financial Trajectory

The financial trajectory of the carboplatin market is positive, driven by the factors mentioned above. The market's projected growth to USD 2.5 billion by 2031 indicates a robust financial outlook. Pharmaceutical companies and investors can capitalize on this growing market by focusing on innovation, new research, and strategic partnerships[1].

Key Takeaways

• The carboplatin market is expected to grow from USD 1.5 billion in 2023 to USD 2.5 billion by 2031, with a CAGR of 6.2%.
• Rising global cancer incidence rates, improvements in oncology research, and growing geriatric populations are key drivers of market growth.
• North America and the Asia-Pacific region are significant markets, with the latter showing rapid growth.
• Carboplatin is cost-effective in treatment sequences and offers favorable patient outcomes.
• Drug shortages, such as the recent one in the U.S., pose significant challenges but also highlight the need for resilient supply chains.
• Future trends include combination therapies, personalized medicine, and strategic partnerships.

FAQs

Q: What is the primary use of carboplatin in cancer treatment? A: Carboplatin is primarily used to treat various cancers, including ovarian, lung, and bladder cancers, by binding to DNA in cancer cells and inhibiting replication and transcription[4].

Q: What are the main drivers of the carboplatin market growth? A: The main drivers include the rising global cancer burden, improvements in oncology research, growing geriatric population, and regulatory approvals for new indications and formulations[1][4].

Q: How is the Asia-Pacific region contributing to the carboplatin market? A: The Asia-Pacific region is contributing through increased investment in cancer care, improved healthcare access, and rising disposable incomes, particularly in countries like India and China[4].

Q: What are the challenges faced by the carboplatin market? A: One of the significant challenges is the drug shortage, such as the recent shortage in the U.S. caused by an FDA inspection of an Indian manufacturing facility[5].

Q: What are the future trends in the carboplatin market? A: Future trends include research into combination therapies, a focus on personalized medicine, and strategic partnerships between pharmaceutical companies and research institutions[4].

Sources

1. Market Research Intellect: Carboplatin Market Size, Share & Trends [2031][1]
2. PMC: Cost-Effectiveness of Pharmacologic Treatment Options for Women[2]
3. AJMC: Complex Path to Cancer Drug Shortages Leads to Hard Realities for Patients[3]
4. Market Research Intellect: Carboplatin Market Dynamics: How New Research is Transforming Cancer Care[4]
5. CancerNetwork: Pharmacy Expert Details Causes of Carboplatin/Cisplatin Shortage in the U.S.[5]