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-one 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:	1
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	633
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
Rutgers, The State University of New Jersey	PHASE4
H. Lee Moffitt Cancer Center and Research Institute	PHASE2
Dartmouth-Hitchcock Medical Center	Phase 1/Phase 2

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	020896-001	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 XELODA

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/002568Capecitabine 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/002386Capecitabine 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/002362Capecitabine 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/000316Xeloda 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/002605Ecansya 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
Sun Pharmaceutical Industries Europe B.V.	Capecitabine SUN	capecitabine	EMEA/H/C/002050Capecitabine 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

International Patents for XELODA

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

Country	Patent Number	Title	Estimated Expiration
Norway	934671
China	1022688
Norway	885106
Georgia, Republic of	P20074251	N-OXYCARBONYL SUBSTITUTED 5'- DEOXY-5-FLUOROCYTIDINES
South Africa	8808428
South Korea	970000241

Supplementary Protection Certificates for XELODA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2001C/021	Belgium		PRODUCT NAME: CAPECITABINE, NATL REGISTRATION NO/DATE: EU/1/00/163/001 20010205; 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
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

Market Dynamics and Financial Trajectory for XELODA (Capecitabine)

Last updated: November 20, 2025

Introduction
XELODA, marketed under the generic name capecitabine, is an oral chemotherapeutic agent primarily used in the treatment of various cancers, including colorectal, breast, gastric, and metastatic HER2-negative breast cancers. Since its approval by the U.S. Food and Drug Administration (FDA) in 2005, XELODA has established itself as a pivotal drug within oncology treatment protocols. Its unique mechanism of selective activation within tumor tissue and the convenience of oral administration have influenced market dynamics and financial trajectories significantly.

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1. Market Overview and Therapeutic Positioning
Capecitabine’s clinical profile addresses unmet needs for oral chemotherapeutics that offer comparable efficacy to intravenous agents while enhancing patient compliance. Its approval predicated on demonstrating non-inferiority to 5-fluorouracil (5-FU), positioning it as a convenient alternative with a favorable safety profile. The global oncology drugs market, projected to reach USD 255 billion by 2027 (CAGR of approximately 7%), provides a robust environment for XELODA’s growth.

2. Drivers of Market Growth

• Expanding Indications: Besides approved uses, ongoing clinical trials explore capecitabine in combination with immunotherapies and targeted agents, broadening its application scope.
• Oral Chemotherapy Trend: Preference for oral over intravenous therapies enhances patient adherence and reduces healthcare costs, fueling demand for capecitabine.
• Rising Cancer Incidence: Global rise in colorectal and breast cancers, notably in Asia-Pacific and North America, directly increases market size for XELODA. The WHO estimates over 19 million new cancer cases annually (2020), with colorectal and breast cancers constituting a significant share.
• Regulatory Approvals: Extended approvals in emerging markets (e.g., China, India) bolster sales channels and geographic reach.

3. Competitive Landscape
While XELODA holds a strong market position, it faces competition from other oral chemotherapies such as S-1, UFT, and capecitabine generics. Patent expirations and generic availability have both eroded its exclusive pricing power but increased accessibility. Multinational pharmaceutical companies, like Roche (which markets XELODA), maintain differentiation through clinical evidence, combination therapy regimens, and patient support programs.

4. Market Challenges

• Pricing Pressures: Reimbursement restrictions and cost-containment measures in major markets exert downward price pressure.
• Side Effect Management: Gastrointestinal toxicity, hand-foot syndrome, and myelosuppression necessitate monitoring and supportive care, impacting utilization rates.
• Consolidation of Generic Market: Increasing generic competition dilutes revenue potential, especially as patent exclusivity diminishes.

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5. Financial Trajectory and Revenue Projections
Roche's 2022 reports indicate that XELODA remains a significant revenue contributor within the oncology portfolio, though exact figures are proprietary. Analysts estimate global sales hovering around USD 1.2 billion annually, with regional variations — North America and Europe comprise approximately 65%, with Asia-Pacific rapidly gaining market share due to rising cancer burden and favorable regulatory environments.

Historical Sales and Growth Trends
From 2015 to 2020, XELODA experienced a compound annual growth rate (CAGR) of approximately 4%, driven by expansion in emerging markets and combination therapy indications. Post-2020, growth has slowed marginally owing to patent expiry effects and generic competition.

Future Financial Outlook
Projections suggest a gradual stabilization of revenues with potential upticks linked to combination therapies. Clinical trials incorporating XELODA with immunotherapy agents like pembrolizumab or trastuzumab are promising, indicating possible label expansions. Overall, industry forecasts predict a compound growth rate of 2–3% over the next five years, contingent on regulatory approvals, patent landscapes, and strategic marketing.

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6. Impact of Biosimilars and Generics
The expiration of primary patents in key markets (e.g., North America in 2015, Europe in 2017) has catalyzed the entry of generics, disrupting Roche’s pricing power. Market share shifts towards generics eroded revenue margins but increased access. A strategic response involves expanding indications, optimizing supply chains, and exploring combination therapy markets to sustain profitability.

7. Regulatory and Reimbursement Environment
Reimbursement policies remain a significant determinant of market performance. In major markets, XELODA benefits from inclusion in standard treatment guidelines (e.g., NCCN, ESMO). However, reimbursement cuts and emphasis on cost-effective therapies threaten profit margins. The introduction of biosimilars and generics further accelerates pricing pressures.

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8. Strategic Initiatives and Market Expansion

• Innovative Combinations: Roche and partners actively develop combination regimens incorporating XELODA to improve efficacy.
• Post-Patent Strategies: Focused on emerging markets with higher unmet needs, regulatory agility, and reduced pricing constraints.
• Digital & Patient Support: Leveraging digital health and patient adherence programs to enhance market penetration and optimize treatment outcomes.

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Key Takeaways

• Market growth is driven by increased cancer incidence, efficacy, and patient preference for oral chemotherapeutics.
• Competitive pressures and patent expiries challenge revenue stability, necessitating strategic diversification and innovation.
• Expanding indications and combination therapies offer potential upside for clinical and financial growth.
• Emerging markets present significant opportunities, especially as regulatory barriers decrease.
• Pricing and reimbursement policies remain pivotal; engagement with healthcare stakeholders is critical for sustainable growth.

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FAQs

1. What are the primary factors influencing XELODA’s market share?
Market share depends on clinical efficacy, patent status, pricing strategies, reimbursement policies, and competition from generics. Strategic expansion into new indications and combination regimens also influence market position.

2. How does patent expiry affect XELODA’s revenue trajectory?
Patent expiry opens the market to generics, leading to price erosion and reduced revenue margins for the innovator. However, it also broadens market access due to lower prices, potentially increasing volume sales in price-sensitive regions.

3. What are the future prospects for XELODA’s growth?
Growth prospects hinge on regulatory approvals for new indications, successful combination therapies, and expansion into emerging markets. Innovations in drug delivery and supportive care can also enhance adoption.

4. How does the competitive landscape impact the financial trajectory of XELODA?
Intense competition from generic versions and alternative therapies compresses pricing power, necessitating cost management and strategic differentiation to sustain revenue streams.

5. What strategies are pharmaceutical companies adopting to offset patent expiration impacts?
Companies are investing in pipeline expansion, developing new combination aids, targeting untapped markets, engaging in licensing deals, and enhancing patient support programs to sustain market relevance.

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References
[1] Roche Annual Report 2022.
[2] World Health Organization Cancer Factsheet, 2020.
[3] Market Research Future Reports on Oncology Drugs, 2022.
[4] European Medicines Agency (EMA) Drug Approvals Database.
[5] National Comprehensive Cancer Network (NCCN) Guidelines, 2023.