CAPECITABINE - Generic Drug Details

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

Capecitabine is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms, Dr Reddys, Eugia Pharma, Hetero Labs Ltd V, Hikma, MSN, Reliance Life, Rising, Shilpa, Sun Pharm, Teva Pharms Usa, Teyro Labs, and Cheplapharm, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for capecitabine. Twenty-four suppliers are listed for this compound.

Summary for CAPECITABINE

US Patents:	0
Tradenames:	2
Applicants:	15
NDAs:	15
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	24
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	1,785
Patent Applications:	7,051
Drug Prices:	Drug price trends for CAPECITABINE
What excipients (inactive ingredients) are in CAPECITABINE?	CAPECITABINE excipients list
DailyMed Link:	CAPECITABINE at DailyMed

See drug prices for CAPECITABINE

Recent Clinical Trials for CAPECITABINE

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

Sponsor	Phase
Dartmouth-Hitchcock Medical Center	Phase 1/Phase 2
Lee Ocuin, MD	Phase 2
Henry Ford Health System	Phase 1

See all CAPECITABINE clinical trials

Pharmacology for CAPECITABINE

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Medical Subject Heading (MeSH) Categories for CAPECITABINE

Antimetabolites, Antineoplastic

Anatomical Therapeutic Chemical (ATC) Classes for CAPECITABINE

L01BC	Pyrimidine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for CAPECITABINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XELODA	Tablets	capecitabine	150 mg and 500 mg	020896	1	2008-11-10

US Patents and Regulatory Information for CAPECITABINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msn	CAPECITABINE	capecitabine	TABLET;ORAL	209365-001	Jul 2, 2018	AB	RX	No	No
Hikma	CAPECITABINE	capecitabine	TABLET;ORAL	200483-002	Jul 14, 2016		DISCN	No	No
Alkem Labs Ltd	CAPECITABINE	capecitabine	TABLET;ORAL	207652-002	Nov 24, 2017	AB	RX	No	No
Shilpa	CAPECITABINE	capecitabine	TABLET;ORAL	207456-001	Dec 12, 2016	AB	RX	No	No
Hikma	CAPECITABINE	capecitabine	TABLET;ORAL	200483-001	Jul 14, 2016		DISCN	No	No

Expired US Patents for CAPECITABINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-001	Apr 30, 1998
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-002	Apr 30, 1998
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-002	Apr 30, 1998
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-001	Apr 30, 1998

EU/EMA Drug Approvals for CAPECITABINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
medac Gesellschaft für klinische Spezialpräparate mbH	Capecitabine Medac	capecitabine	EMEA/H/C/002568 Capecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.Capecitabine Medac is indicated for the treatment of metastatic colorectal cancer.Capecitabine Medac is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Capecitabine Medac in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Capecitabine Medac is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.	Authorised	yes	no	no	2012-11-19
Accord Healthcare S.L.U.	Capecitabine Accord	capecitabine	EMEA/H/C/002386 Capecitabine Accord is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.Capecitabine Accord is indicated for the treatment of metastatic colorectal cancer.Capecitabine Accord is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Capecitabine Accord in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline.Capecitabine Accord is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.	Authorised	yes	no	no	2012-04-20
Teva Pharma B.V.	Capecitabine Teva	capecitabine	EMEA/H/C/002362 Capecitabine Teva is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes’ stage C) colon cancer.Capecitabine Teva is indicated for the treatment of metastatic colorectal cancer.Capecitabine Teva is indicated for first‑line treatment of advanced gastric cancer in combination with a platinum‑based regimen.Capecitabine Teva in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Capecitabine Teva is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.	Authorised	yes	no	no	2012-04-20
CHEPLAPHARM Arzneimittel GmbH	Xeloda	capecitabine	EMEA/H/C/000316 Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer.Xeloda is indicated for the treatment of metastatic colorectal cancer.Xeloda is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Xeloda in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Xeloda is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.	Authorised	no	no	no	2001-02-02
Krka, d.d., Novo mesto	Ecansya (previously Capecitabine Krka)	capecitabine	EMEA/H/C/002605 Ecansya is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.Ecansya is indicated for the treatment of metastatic colorectal cancer.Ecansya is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Ecansya in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Ecansya is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.	Authorised	yes	no	no	2012-04-20

CAPECITABINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Capecitabine

Introduction

Capecitabine, an oral chemotherapeutic agent, has been a significant player in the oncology market, particularly in the treatment of various types of cancer, including breast, colorectal, and gastric cancers. This article delves into the market dynamics and financial trajectory of capecitabine, highlighting its current market size, growth prospects, and the factors influencing its adoption.

Current Market Size and Growth

The capecitabine market has experienced robust growth in recent years. As of 2023, the market size was valued at $2.06 billion and is projected to increase to $2.25 billion in 2024, reflecting a compound annual growth rate (CAGR) of 9.4%[1].

Forecasted Growth

Looking ahead, the capecitabine market is expected to continue its upward trend. By 2028, the market is anticipated to reach $3.14 billion, growing at a CAGR of 8.7%[1]. This growth is driven by several key factors, including expanded indications, research in combination therapies, healthcare infrastructure development, government initiatives, and increasing adoption in developing countries.

Key Drivers of Growth

Chemotherapy Advancements

Advancements in chemotherapy have significantly contributed to the growth of the capecitabine market. The convenience of oral administration and the drug's efficacy in treating various cancers have made it a preferred choice among oncologists[1].

Regulatory Approvals

Regulatory approvals and the expansion of indications have further bolstered the market. As capecitabine gains approval for additional cancer types, its market reach and penetration are expected to increase[1].

Healthcare Infrastructure Development

The development of healthcare infrastructure, particularly in developing countries, is another crucial factor. Improved access to healthcare facilities and treatments is likely to drive the demand for capecitabine[1].

Government Initiatives

Government initiatives aimed at increasing cancer treatment accessibility and awareness programs by private organizations are also propelling the market forward. These initiatives help in raising awareness and facilitating the adoption of capecitabine among a broader patient population[4].

Market Trends

Targeted Therapy Combinations

One of the major trends in the capecitabine market is the integration of targeted therapy combinations. Research into combination therapies, such as the use of utidelone and capecitabine, is showing promising results in terms of improved patient outcomes, although these combinations come with higher costs[5].

Expanded Use in Adjuvant Settings

Capecitabine is increasingly being used in adjuvant settings to prevent cancer recurrence. This expanded use is contributing to the market's growth as more patients are treated with capecitabine to reduce the risk of cancer relapse[1].

Biomarker-Driven Treatment

The use of biomarkers to tailor treatment plans is becoming more prevalent. Biomarker-driven treatment approaches are helping to optimize the use of capecitabine, making it more effective and reducing unnecessary side effects[1].

Enhanced Pharmacogenomics

Advances in pharmacogenomics are allowing for more personalized treatment plans. This personalized approach ensures that patients receive the most effective treatment based on their genetic profiles, further enhancing the market for capecitabine[1].

Telehealth Monitoring

The integration of telehealth monitoring is also a significant trend. Telehealth allows for remote monitoring of patients, which can improve adherence to treatment and overall patient outcomes, thereby supporting the growth of the capecitabine market[1].

Cost-Effectiveness Analysis

Combination Therapies vs. Monotherapy

A recent study comparing the cost-effectiveness of a combination therapy (utidelone and capecitabine) versus capecitabine monotherapy in treating advanced metastatic breast cancer revealed some interesting insights. While the combination therapy resulted in higher costs (an incremental cost of $26,370.63 over a 5-year period), it also conferred an additional 0.49 quality-adjusted life years (QALYs) compared to monotherapy. The incremental cost-effectiveness ratio (ICER) was estimated at $53,874.17/QALY, which may not be consistently deemed cost-effective at traditional willingness-to-pay thresholds. However, in specific patient groups, the combination therapy was found to be more cost-effective[5].

Breakdown of Costs

The cost breakdown for the combination therapy versus monotherapy includes significant differences in drug acquisition, administration, laboratory tests, treatment-related adverse events, and terminal care. For instance, the drug acquisition cost for the combination therapy was $27,177.38 compared to $3,327.61 for monotherapy[5].

Economic Impact

The economic impact of capecitabine is substantial, given its widespread use and the growing global burden of cancer. According to the World Health Organization, cancer is a leading cause of death worldwide, with nearly 9.6 million deaths in 2018. The increasing healthcare expenditure and ongoing R&D activities in cancer treatment are providing new opportunities for the capecitabine market[4].

Industry Expert Insights

Industry experts emphasize the importance of balancing therapeutic quality and expenditure. As noted by researchers, "Exorbitant treatments, irrespective of their clinical prowess, may face hesitancy in adoption. Contemplating these dynamics and anchoring on clinical trial data, our research endeavors to discern the cost-efficacy of combination therapies vis-à-vis monotherapy"[5].

Global Burden of Cancer

The global burden of cancer continues to drive the demand for effective treatments like capecitabine. With an estimated 627,000 women dying from breast cancer in 2018, accounting for about 15% of all cancer deaths among women globally, the need for robust cancer treatments is more pressing than ever[4].

Conclusion

The capecitabine market is poised for significant growth driven by advancements in chemotherapy, regulatory approvals, healthcare infrastructure development, and government initiatives. While combination therapies offer improved patient outcomes, they also come with higher costs, necessitating a careful cost-effectiveness analysis. As the global burden of cancer continues to rise, the demand for capecitabine and other cancer treatments is expected to increase, making it a vital component of modern oncology.

Key Takeaways

• The capecitabine market is expected to grow from $2.06 billion in 2023 to $3.14 billion by 2028.
• Key drivers include chemotherapy advancements, regulatory approvals, and healthcare infrastructure development.
• Combination therapies, such as utidelone and capecitabine, offer improved outcomes but at higher costs.
• Cost-effectiveness analysis is crucial for determining the viability of combination therapies.
• The global burden of cancer continues to drive the demand for effective treatments like capecitabine.

FAQs

What is the current market size of capecitabine?

The current market size of capecitabine was valued at $2.06 billion in 2023[1].

What is the projected growth rate of the capecitabine market?

The capecitabine market is projected to grow at a CAGR of 8.7% from 2023 to 2028[1].

What are the key drivers of the capecitabine market growth?

Key drivers include chemotherapy advancements, regulatory approvals, healthcare infrastructure development, government initiatives, and increasing adoption in developing countries[1].

How does the cost of combination therapy compare to monotherapy?

The combination therapy of utidelone and capecitabine incurs significantly higher costs than capecitabine monotherapy, with an incremental cost of $26,370.63 over a 5-year period[5].

Is the combination therapy of utidelone and capecitabine cost-effective?

The combination therapy may not be consistently deemed cost-effective at traditional willingness-to-pay thresholds, but it is more cost-effective in specific patient groups[5].

Sources

1. The Business Research Company. Global Capecitabine Market Report 2024.
2. Frontiers in Pharmacology. Cost-effectiveness of utidelone and capecitabine versus capecitabine monotherapy in advanced metastatic breast cancer.
3. Aviaan Accounting. Capecitabine Market Size, Share, Growth, Forecast Data, Statistics & Feasibility Study Report.
4. Mordor Intelligence. Capecitabine Market - Size, Share & Industry Analysis.
5. Frontiers in Pharmacology. Cost-effectiveness of utidelone and capecitabine versus capecitabine monotherapy in advanced metastatic breast cancer.