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. Nineteen 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		DISCN	Yes	No
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-002	Apr 30, 1998		DISCN	Yes	No

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	4,966,891
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896-002	Apr 30, 1998	4,966,891

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
Argentina	247217	UN PROCEDIMIENTO PARA LA PREPARACION DE NUEVOS DERIVADOS DE 5'-DEOXI-FLUOROCITIDINA. (A PROCEDURE FOR THE PREPARATION OF NEW DERIVATIVES OF 5'-DEOXI-FLUOROCITIDINE.)
Austria	124951
Australia	2516888
Australia	619220
Canada	1327358	DERIVES FLUOROCYTIDINE (FLUORO CYTIDINE DERIVATIVES)
China	1022688

Supplementary Protection Certificates for XELODA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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

Last updated: July 30, 2026

XELODA (capecitabine) market dynamics and financial trajectory: pricing, volume, competitive pressure, and patent/generic timing

Executive summary: XELODA (capecitabine) is a long-standing oncology oral antimetabolite with a mature, patent-expired commercial profile in most major markets. The market is driven by (1) continued label penetration in metastatic and adjuvant settings, (2) steady but decelerating unit demand as dosing converts to competing regimens, and (3) increasing price pressure from multisource generics after patent/regulatory exclusivity ended. Financial performance has historically been supported by robust global sales through mid-to-late 2010s, with later-stage declines tied to generic erosion, guideline shifts toward newer combinations, and slower growth in second-line and adjuvant expansions.

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What is XELODA’s current market position and how big is the capecitabine opportunity?

Quick read: XELODA is the reference brand for capecitabine. Commercially, capecitabine is a platform drug across breast, colorectal, and gastric cancers. The addressable market persists due to high utilization of fluoropyrimidine-based chemotherapy, but brand economics compress as generic share rises.

Where XELODA is used most

Capecitabine use concentrates in:

• Metastatic colorectal cancer (often combined with oxaliplatin regimens depending on geography and line of therapy).
• Adjuvant colon cancer (post-surgery settings where capecitabine competes with infusional 5-FU/LV and newer options).
• Metastatic breast cancer (capecitabine commonly used in later-line settings, including combination with other agents depending on protocols).
• Gastric and gastroesophageal settings (region- and guideline-dependent).

Key demand drivers

• Oral convenience reduces infusion capacity constraints versus infusional 5-FU/LV in many healthcare systems.
• Clinical inertia: capecitabine remains a default fluoropyrimidine backbone, which sustains baseline demand even as newer regimens enter.
• Combination dependence: once a regimen is established in practice, switching can be slow.

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Why do capecitabine unit growth and pricing diverge after generic entry?

Quick read: After generic entry, market growth often continues slowly, but brand revenue declines faster due to pricing compression and payer switching.

What typically happens to brand economics

• Price erosion begins immediately post-launch of lower-cost competitors, especially in tenders and preferred formulary positioning.
• Volume cannibalization occurs as prescribers shift to generics where therapeutic equivalence is accepted and supply is stable.
• Mix shift can partially offset unit declines if brand usage is preserved in specific subgroups or through contracts, but this is usually insufficient for long-term revenue stability.

Competitive structure that shapes pricing

Capecitabine is commonly produced by multiple manufacturers across major markets. When even a subset gains scale, the competitive equilibrium typically moves toward:

• lower average selling prices,
• faster switching by payers,
• more aggressive discounting in hospital and retail channels.

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How does XELODA’s financial trajectory compare with generic capecitabine benchmarks?

Quick read: The financial pattern for long-cycle oncology brands that lose exclusivity is generally: peak sales under brand protection, then accelerated declines as generics take formulary share, followed by stabilization at reduced revenue levels tied to contracts and residual brand use.

Brand-to-generic financial dynamics

For capecitabine, the primary determinants of brand revenue trajectory are:

• timing and intensity of generic launches in each market,
• payer tender cycles and reimbursement policies,
• contract pharmacy penetration and wholesaler discount structures,
• the extent to which oncology treatment protocols continue to include XELODA as preferred brand versus interchangeables.

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When does XELODA lose exclusivity, and what are the generic entry risks?

Quick read: XELODA’s core patent and exclusivity protections are long expired in most major markets, making the dominant risk factor for remaining brand share the speed and breadth of generic penetration rather than a single near-dated Paragraph IV event.

Patent and exclusivity timeline mechanics (how the market responds)

Generic entry risk in fluoropyrimidine oncology products tends to be driven by:

• expiration of the last listed formulation or method claims in the key jurisdictions,
• any remaining orphan/exclusivity or supplementary protection instruments (where applicable),
• how quickly ANDA approvals translate into commercial stocking by payers and wholesalers.

Paragraph IV and settlement impact on brand erosion

When a brand has multiple Orange Book listed patents, litigation and settlements can delay launch. For capecitabine’s long-lived brand, the modern market regime is typically post-settlement, where generic uptake is determined more by market access than by litigation timing.

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What patents protect capecitabine and which patent estate factors still matter for market dynamics?

Quick read: While the market is primarily post-core exclusivity, later-stage formulation and method-of-use patents (where still active in specific jurisdictions) can influence launch sequencing, labeling carve-outs, and substitution in certain channels.

How patent estate breadth affects generic uptake speed

Even after core active ingredient protections end:

• Formulation/combination patents can block “skinny” launches in certain dosing strengths or specific excipient systems.
• Method-of-use can limit promotion for particular indications, slowing early uptake.
• Manufacturing-process patents can add barriers where process design-arounds are difficult.

Practical commercial outcome

For an entrenched oncology oral like capecitabine, the market response still concentrates on:

• interchangeability guidance and payer policy,
• available generic supply breadth,
• national tender structures and contract award periods.

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What is the FDA regulatory status of XELODA and how does it shape generic availability?

Quick read: XELODA is an FDA-approved brand capecitabine product that has been widely substituted by multiple FDA-approved generics over time. The regulatory status governs availability rather than ongoing brand differentiation, because most substitution occurs at the product level through FDA bioequivalence approvals.

Key regulatory mechanics that influence competitive timing

• ANDA approvals determine product-level market entry.
• Labeling and listed indications affect payer comfort and substitution rates.
• Manufacturing site approvals influence supply continuity and the speed at which payers fully switch.

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What formulation and dosage strengths matter for competition?

Quick read: Capecitabine is typically marketed as oral tablets in multiple strengths. Competitive intensity can vary by strength due to:

• manufacturing capacity,
• stability requirements,
• packaging and distribution efficiencies,
• wholesaler ordering patterns.

Where brand vs generic share often differs

• hospital procurement contracts can retain reference product longer in the initial post-launch window,
• pharmacy benefit structures can switch faster due to lower copays on generics,
• specialty oncology pharmacies may maintain brand for continuity until supply or economics force conversion.

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Which companies dominate generic capecitabine supply and how does that influence pricing?

Quick read: Generic capecitabine markets usually have multiple established suppliers. When several achieve significant share, pricing converges to a low but stable band that depends on:

• number of active competitors,
• manufacturing uptime,
• raw material costs,
• tender dynamics.

Commercial effects of supply concentration

• stable supply supports faster payer switching,
• supply disruptions can temporarily restore higher prices and preserve some brand demand,
• regional differences in supplier presence can create uneven substitution patterns.

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How does XELODA’s competitive landscape evolve versus infusional 5-FU regimens and newer targeted therapies?

Quick read: Capecitabine competes against:

• infusional fluoropyrimidines (5-FU/LV),
• other oral fluoropyrimidines in select settings,
• and newer combinations that can displace fluoropyrimidine backbone use in some advanced-line settings.

Why capecitabine retains demand

• consistent efficacy profile across fluoropyrimidine-based regimens,
• manageable safety profile relative to some alternatives,
• operational advantages due to oral dosing.

Where substitution accelerates

• when clinical pathways favor chemotherapy combinations with different backbones,
• when payers push lowest-cost option policies,
• when oral convenience is matched by multiple low-cost equivalents.

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What litigation and settlements have shaped capecitabine market access?

Quick read: For long-duration brands like XELODA, litigation typically matters most at the margin during early generic entry phases. After multiple generations of generics, the market impact becomes dominated by pricing and formulary cycles rather than ongoing disputes.

Litigation as a market timing lever

Settlement terms can:

• delay specific ANDA launches,
• limit the timing of entry by strength or indication,
• shape early competitor selection and subsequent market structure.

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How do geography and reimbursement systems alter XELODA’s financial trajectory?

Quick read: XELODA’s brand revenue path is not uniform across regions. It depends on:

• national price regulation,
• tender and reimbursement rules,
• substitution enforcement,
• wholesaler stocking and distribution incentives.

Typical cross-market outcomes

• jurisdictions with strict price controls and mandatory substitution can see faster revenue erosion,
• markets with tender-only procurement can experience “lumpy” brand declines around contract award cycles,
• markets with slower substitution can support brand presence longer, limiting downside.

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What is the revenue exposure and valuation sensitivity to capecitabine price compression?

Quick read: XELODA’s remaining brand value is mainly sensitive to:

• gross-to-net changes (discounting, rebates, tender outcomes),
• generic price erosion and competitive intensity,
• volume capture loss to generics,
• mix of strengths and channel (hospital vs retail).

Risk factors that compress revenue further

• increased generic competition at the same dosage strengths,
• tender awards shifting to lower-cost suppliers,
• reduced physician brand preference over time,
• reimbursement rule tightening that expands generic substitution.

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How strong is the patent estate for capecitabine at this stage?

Quick read: For most major jurisdictions, capecitabine’s core protections are already off. Any remaining patent relevance tends to be:

• localized to specific formulation or method claims,
• limited in practical ability to prevent generic substitution at the product level,
• or relevant only for certain niche channel/indication arguments.

Commercial implication

Market pricing is driven primarily by:

• generics availability and supply stability,
• payer economics,
• and standard of care evolution, rather than by brand exclusivity.

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Key Takeaways

• XELODA’s market is sustained by durable fluoropyrimidine backbone usage in oncology, but brand economics are governed by post-exclusivity generic penetration.
• Competitive pressure manifests through payer switching, tender cycles, and ongoing pricing compression that typically outpaces unit growth.
• Financial trajectory follows a classic pattern: strong brand years under protection, then sustained decline after broad generic entry, with any remaining revenue supported by residual brand preference in specific channels/contracts.
• In the current regime, litigation and patent estate effects are usually second-order versus ongoing generic supply and reimbursement dynamics.

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FAQs

1) Does XELODA face biosimilar risk?
No. Capecitabine is a small-molecule, so the competitive pathway is via generics/ANDAs, not biosimilars.

2) Are there still market opportunities for branded capecitabine despite generics?
Opportunities usually concentrate in contract-specific retention, channel-specific inertia, and supply or tender timing rather than long-term IP exclusivity.

3) How do dosing strength differences affect generic substitution speed?
Strengths with broader generic supply and smoother logistics typically see faster switching, while constrained supply can delay conversion.

4) What reimbursement levers most influence XELODA pricing?
Formulary tiering, copay design, tender award outcomes, and gross-to-net rebate structures.

5) How does treatment line (adjuvant vs metastatic) influence capecitabine demand?
Adjuvant use can create steadier baseline demand, while metastatic use is more sensitive to regimen changes and payer pathway constraints.

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References (APA)

1. U.S. Food and Drug Administration. (n.d.). Drug approvals and databases (Drugs@FDA, Orange Book). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. U.S. Food and Drug Administration. (n.d.). FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/