XELODA Drug Patent Profile

Which patents cover Xeloda, and what generic alternatives are available?

Xeloda is a drug marketed by Cheplapharm and is included in one NDA.

The generic ingredient in XELODA is capecitabine. There are twenty-eight drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the capecitabine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xeloda

A generic version of XELODA was approved as capecitabine by TEVA PHARMS USA on September 16^th, 2013.

Summary for XELODA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	631
Drug Prices:	Drug price information for XELODA
What excipients (inactive ingredients) are in XELODA?	XELODA excipients list
DailyMed Link:	XELODA at DailyMed

See drug prices for XELODA

Recent Clinical Trials for XELODA

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

Sponsor	Phase
Dartmouth-Hitchcock Medical Center	Phase 1/Phase 2
University of Alabama at Birmingham	Phase 2
Henry Ford Health System	Phase 1

See all XELODA clinical trials

Pharmacology for XELODA

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

Paragraph IV (Patent) Challenges for XELODA

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 XELODA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-001	Apr 30, 1998	AB	RX	Yes	No
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-002	Apr 30, 1998	AB	RX	Yes	Yes

Expired US Patents for XELODA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-002	Apr 30, 1998	4,966,891
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-002	Apr 30, 1998	5,472,949*PED
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-001	Apr 30, 1998	4,966,891
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-001	Apr 30, 1998	5,472,949*PED

EU/EMA Drug Approvals for XELODA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
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
Sun Pharmaceutical Industries Europe B.V.	Capecitabine SUN	capecitabine	EMEA/H/C/002050 Capecitabine is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer.Capecitabine is indicated for the treatment of metastatic colorectal cancer.Capecitabine is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen.Capecitabine 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 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.	Withdrawn	yes	no	no	2013-06-21
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
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
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
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

International Patents for XELODA

See the table below for patents covering XELODA around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	170893
Finland	89804
Japan	2501297
Norway	2001013
Russian Federation	2493162	N-ОКСИКАРБОНИЛЗАМЕЩЕННЫЕ 5'-ДЕОКСИ-5-ФТОРЦИТИДИНЫ И ФАРМАЦЕВТИЧЕСКИЙ ПРЕПАРАТ (N-OXYCARBONYL-SUBSTITUTED 5'-DEOXY-5-FLUOROCYTIDINES AND PHARMACEUTICAL PREPARATION)
Yugoslavia	49411

Supplementary Protection Certificates for XELODA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0316704	14/2001	Austria		PRODUCT NAME: CAPECITABIN; NAT. REGISTRATION NO/DATE: - 20010202; FIRST REGISTRATION: EU EU/1/00/163/001, EU/1/00/163/002 20010202
0316704	2001C/021	Belgium		PRODUCT NAME: CAPECITABINE, NATL REGISTRATION NO/DATE: EU/1/00/163/001 20010205; FIRST REGISTRATION: CH 54657 19980610
0316704	C300045	Netherlands		PRODUCT NAME: CAPECITABINE,DESGEWENST IN DE VORM VAN EEN SOLVAAT; NATL REGISTRATION NO/DATE: EU/1/00/163/001-002 20010202; FIRST REGISTRATION: CH 54657 19980610
0316704	SPC/GB01/015	United Kingdom		PRODUCT NAME: CAPECITABINE AND HYDRATES AND SOLVATES THEREOF; REGISTERED: CH 54657 19980610; UK EU/1/00/163/001-002 20010202

Market Dynamics and Financial Trajectory for Xeloda (Capecitabine)

Introduction

Xeloda, known generically as capecitabine, is a pivotal chemotherapy drug used in the treatment of various cancers, including breast cancer, colorectal cancer, and bowel cancer. This article delves into the market dynamics and financial trajectory of Xeloda, highlighting its current market status, growth prospects, and key factors influencing its demand.

Market Overview

The global capecitabine market is experiencing significant growth, driven primarily by the increasing incidence of cancer and advancements in chemotherapy treatments. As of 2023, the market was valued at approximately USD 2.06 billion and is projected to reach USD 2.25 billion in 2024, with a compound annual growth rate (CAGR) of 9.4%[4].

Market Size and Growth Projections

By 2029, the global capecitabine market is expected to grow at a CAGR of 6.2%, reaching a market size of USD 631.96 million from USD 467.81 million in 2024[1]. This growth is attributed to the expanding indications for capecitabine, research in combination therapies, and improvements in healthcare infrastructure.

Regional Market Analysis

North America dominated the capecitabine market in 2023, reflecting a high demand for cancer treatments in this region. Other significant regions include Asia-Pacific, Western Europe, Eastern Europe, South America, Middle East, and Africa. The market's geographical spread indicates a global need for effective cancer therapies[4].

Market Drivers

Several factors are driving the growth of the capecitabine market:

Increasing Incidence of Cancer

The rising number of cancer cases globally is a primary driver. For instance, in 2017, there were 135,431 new cases and 50,260 deaths from colon and rectal cancer in the US alone, according to the American Cancer Society[1].

Chemotherapy Advancements

Advancements in chemotherapy, including the convenience of oral administration and regulatory approvals, have enhanced the market for capecitabine. The drug's ability to inhibit cell reproduction and repair DNA makes it a preferred choice for oncologists[4].

Expanded Indications and Research

Research in combination therapies and the expansion of indications for capecitabine are expected to further boost market growth. Trends such as targeted therapy combinations, expanded use in adjuvant settings, biomarker-driven treatment, and enhanced pharmacogenomics are also contributing factors[4].

Government Initiatives and Healthcare Infrastructure

Government initiatives and improvements in healthcare infrastructure, particularly in developing countries, are increasing access to capecitabine and driving market growth[4].

Competitive Landscape

The capecitabine market is competitive, with several key players involved. F. Hoffmann-La Roche AG, the original manufacturer of Xeloda, has seen significant competition from biosimilar and generic versions. In 2023, Cheplapharm Arzneimittel GmbH acquired the commercial rights for Xeloda in China from Roche, aiming to strengthen its oncology portfolio[4].

Financial Performance

The financial performance of companies involved in the capecitabine market reflects the overall market trends. For example, Roche's Pharmaceuticals Division saw a 6% increase in sales at constant exchange rates (CER) in 2023, driven by growing demand for other oncology products like Vabysmo, Ocrevus, and Hemlibra. However, sales of older drugs like MabThera/Rituxan, Herceptin, and Avastin decreased due to biosimilar competition[2].

Impact of Biosimilars and Generics

The introduction of biosimilars and generics has had a mixed impact on the market. While it has increased competition and reduced prices, it has also expanded access to cancer treatments. For instance, the decline in sales of MabThera/Rituxan, Herceptin, and Avastin by 17% in 2023 was partly due to biosimilar competition, but this also indicates a broader availability of affordable cancer treatments[2].

Market Challenges

Despite the growth prospects, the capecitabine market faces several challenges:

Patent Expirations

Patent expirations for key drugs can lead to increased competition from generics and biosimilars, potentially reducing market share for original manufacturers[2].

Economic Factors

Economic downturns and potential recessions can impact healthcare spending and thus affect the demand for capecitabine. However, the essential nature of cancer treatments often makes this market more resilient to economic fluctuations[3].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics. Changes in regulatory policies can affect the approval and availability of capecitabine and its competitors[4].

Key Takeaways

• The global capecitabine market is projected to grow significantly, driven by increasing cancer incidence and advancements in chemotherapy.
• North America is the largest market, but other regions are also showing substantial growth.
• Expanded indications, research in combination therapies, and government initiatives are key drivers.
• The market faces challenges from biosimilars, generics, and economic factors but remains resilient due to the critical need for cancer treatments.

FAQs

What is the current market size of the global capecitabine market?

The global capecitabine market was valued at approximately USD 2.06 billion in 2023[4].

What is the projected growth rate of the capecitabine market?

The market is expected to grow at a CAGR of 6.2% from 2024 to 2029[1].

Which region dominates the capecitabine market?

North America dominated the capecitabine market in 2023[1].

What are the primary drivers of the capecitabine market growth?

The primary drivers include the increasing incidence of cancer, advancements in chemotherapy, expanded indications, and government initiatives[4].

How does the introduction of biosimilars and generics affect the capecitabine market?

The introduction of biosimilars and generics increases competition, reduces prices, and expands access to cancer treatments, but it also reduces market share for original manufacturers[2].

Sources

1. Marketdataforecast.com: Capecitabine Market Size, Share | 2024 to 2029
2. Roche: Finance Report 2023
3. Globenewswire.com: Global Colorectal Cancer Drugs Market to Reach USD 12.79 Billion by 2028
4. Thebusinessresearchcompany.com: Global Capecitabine Market Report 2024