CLADRIBINE - Generic Drug Details

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

Cladribine is the generic ingredient in three branded drugs marketed by Fresenius Kabi Usa, Hikma, Hisun Pharm Hangzhou, Pharmobedient, Janssen Pharms, and Emd Serono Inc, and is included in six NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cladribine has ninety patent family members in thirty-one countries.

There are eight drug master file entries for cladribine. Four suppliers are listed for this compound.

Summary for CLADRIBINE

International Patents:	90
US Patents:	3
Tradenames:	3
Applicants:	6
NDAs:	6
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	148
Drug Prices:	Drug price trends for CLADRIBINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CLADRIBINE
What excipients (inactive ingredients) are in CLADRIBINE?	CLADRIBINE excipients list
DailyMed Link:	CLADRIBINE at DailyMed

See drug prices for CLADRIBINE

Recent Clinical Trials for CLADRIBINE

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

Sponsor	Phase
Rigel Pharmaceuticals	PHASE2
M.D. Anderson Cancer Center	PHASE2
National Cancer Institute (NCI)	PHASE1

See all CLADRIBINE clinical trials

Pharmacology for CLADRIBINE

Drug Class

Purine Antimetabolite

Medical Subject Heading (MeSH) Categories for CLADRIBINE

Antineoplastic Agents

Immunosuppressive Agents

Anatomical Therapeutic Chemical (ATC) Classes for CLADRIBINE

L01BB	Purine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for CLADRIBINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MAVENCLAD	Tablets	cladribine	10 mg	022561	1	2022-04-07

US Patents and Regulatory Information for CLADRIBINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmobedient	CLADRIBINE	cladribine	INJECTABLE;INJECTION	200510-001	Oct 6, 2011		DISCN	No	No
Fresenius Kabi Usa	CLADRIBINE	cladribine	INJECTABLE;INJECTION	076571-001	Apr 22, 2004	AP	RX	No	Yes
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes	8,377,903
Hisun Pharm Hangzhou	CLADRIBINE	cladribine	INJECTABLE;INJECTION	210856-001	Nov 25, 2019	AP	RX	No	No
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes	7,713,947
Hikma	CLADRIBINE	cladribine	INJECTABLE;INJECTION	075405-001	Feb 28, 2000	AP	RX	No	No

Expired US Patents for CLADRIBINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019	7,888,328
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019	8,785,415

EU/EMA Drug Approvals for CLADRIBINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Europe B.V.	Mavenclad	cladribine	EMEA/H/C/004230Treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features.	Authorised	no	no	no	2017-08-22
Lipomed GmbH	Litak	cladribine	EMEA/H/C/000504Litak is indicated for the treatment of hairy-cell leukaemia.	Authorised	no	no	no	2004-04-14

International Patents for CLADRIBINE

Country	Patent Number	Title	Estimated Expiration
Norway	20073813
Brazil	112020010282
Montenegro	01333	KLADRIBINSKI REŽIM ZA LIJEČENJE MULTIPLE SKLEROZE (CLADRIBINE REGIMEN FOR TREATING MULTIPLE SCLEROSIS)
Spain	2382554
Brazil	PI0517132	regime de cladribina para o tratamento da esclerose múltipla
France	18C1008

Supplementary Protection Certificates for CLADRIBINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1827461	2018C/010	Belgium		PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
1608344	LUC00065	Luxembourg		PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
1827461	122018000021	Germany		PRODUCT NAME: CLADRIBIN; REGISTRATION NO/DATE: EU/1/17/1212 20170822
1827461	C01827461/01	Switzerland		PRODUCT NAME: CLADRIBIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66831 19.03.2019
2805723	C20180006 00238	Estonia		PRODUCT NAME: KLADRIBIIN;REG NO/DATE: EU/1/17/1212 24.08.2017
1827461	132018000000141	Italy		PRODUCT NAME: CLADRIBINA(MAVENCLAD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1212, 20170824

Market Dynamics and Financial Trajectory for Cladribine: An In-Depth Analysis

Last updated: December 15, 2025

Executive Summary

Cladribine, a purine nucleoside analog, has established its role primarily in treating multiple sclerosis (MS) and certain hematological malignancies. Recent regulatory approvals, patent expirations, and competitive landscape shifts are key drivers shaping its market trajectory. This analysis examines current market dynamics, revenue forecasts, competitive positioning, regulatory influences, and future growth prospects. The study underscores emerging opportunities, challenges, and strategic considerations for stakeholders aligned with Cladribine’s evolving ecosystem.

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What is Cladribine and How Does It Work?

Cladribine (brand names: Mavenclad, Leustat) was initially developed for hematological cancers. Its mechanism involves selective lymphocyte depletion, making it effective in autoimmune diseases like multiple sclerosis. Approved by the FDA in 2019 (for relapsing-remitting MS) and EMA in 2017, it offers oral administration with a high efficacy profile. Its pharmacokinetics involve intracellular phosphorylation leading to DNA strand breaks, inducing apoptosis in lymphocytes.

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Current Therapeutic Indications and Market Scope

Indication	Approved Regions	Formulation	Mode of Action
Multiple Sclerosis (RRMS)	US, EU, others	Oral tablets	Lymphocyte depletion via selective apoptosis
Hairy Cell Leukemia (HCL)	US, EU	Intravenous, subcutaneous	Cytotoxic nucleoside analog

Market Penetration (2022 Data):

• MS Market Share: Cladribine holds approximately 4–6% of the global disease-modifying therapy (DMT) market for MS.
• Hematological Malignancies: Limited compared to established agents, with niche positioning primarily in HCL.

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Market Size and Revenue Analysis

Global MS Therapeutic Market (2022)

Segment	Value (USD billion)	CAGR (2022-2027)	Key Competitors
Total MS market	23.1	5.2%	Ocrelizumab, interferons, TEPRISM, Cladribine, etc.
Cladribine's market share	4%–6%

Forecast Revenue for Cladribine (2023-2027):

Year	Estimated Revenue (USD million)	Growth Rate	Assumptions
2023	200	—	Post-pandemic market stabilization
2024	240	20%	Increased adoption, expanding geographic coverage
2025	276	15%	Competitive pressure, market expansion
2026	310	12%	New indications, formulary negotiations
2027	350	13%	Potential regulatory approvals, increased marketing efforts

Hematology Market

Indication	Market Size (USD billions)	Share of total hematology drugs	Opportunity Level
Hairy Cell Leukemia	0.4	Low	Niche

Key Revenue Drivers

• Regulatory Approvals: Expanding indications in MS.
• Patient Accessibility: Oral formulation enhances compliance.
• Pricing & Reimbursement Policies: Variability across regions impacts sales.
• Market Penetration: Physician familiarity and guideline endorsements.
• Patent Status & Generics: Patent expiry potential influences pricing and volume.

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Competitive Landscape

Competitor	Main Products	Market Position	Strengths	Weaknesses
Ocrelizumab	Ocrevus	Leading MS agent	High efficacy	Costly, infusion-based
Fingolimod	Gilenya	Oral, established	Long market presence	Side-effect profile
Siponimod	Mayzent	Approved for secondary progressive MS	Oral, good efficacy	Narrow indication
Immunotherapies	Various	Diverse pipeline	Broad spectrum	Competition from emerging agents

Cladribine’s competitive advantages include oral dosing and a convenient treatment regimen (2-year course), contrasting with continuous infusion or injections required by some peers. However, concerns over lymphopenia and infection risk remain.

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Regulatory and Policy Environment

Key Regulatory Milestones

• FDA (2019): Approved for relapsing-remitting MS.
• EMA (2017): Approved for similar indications.
• China, Japan: Not yet approved, potential markets.

Pricing & Reimbursement

• US & EU: Variable, with high-cost payer negotiations.
• Emerging Markets: Price barriers due to healthcare budgets.
• Reimbursement Policies: Favor oral medications due to convenience, impacting uptake.

Upcoming Policy Trends

• Expanded indications (e.g., secondary progressive MS) could drive growth.
• Orphan drug status in hematology enhances intellectual property protections.
• Risk Management policies for lymphopenia management affect prescribing.

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Market Challenges

Challenge	Impact	Mitigation Strategies
Patent expiration	Loss of exclusivity	Patent extensions, lifecycle management
Safety concerns	Reduced adoption	Enhanced safety profile, real-world data
Competition	Market share erosion	Differentiation through efficacy, convenience
Regulatory delays	Market access barriers	Proactive regulatory engagement

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Emerging Opportunities

• New Indications: Potential approval for secondary progressive MS.
• Combination Therapy: Synergy with other DMTs could broaden usage.
• Biomarker Development: To identify ideal responders, enhancing efficacy.
• Market Expansion: Key in Asia-Pacific, Latin America.

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Financial Trajectory Outlook

Based on current data, the revenue trajectory suggests a steady growth augmented by expanded approvals and market penetration. The primary factors include:

• Market Expansion: Into new regions and indications.
• Pricing Strategies: Negotiation and formulary placements.
• Pipeline & Lifecycle Management: Development of derivatives or formulations to prolong patent life.
• Competitive Positioning: Leveraging unique benefits over rivals.

Year	Revenue Estimate (USD million)	Key Drivers
2023	200	Post-pandemic recovery, awareness campaigns
2024	240	Expanded access, new markets
2025	276	Regulatory approvals, competitive launches
2026	310	Market expansion, formulary inclusion
2027	350	Broader indications, pricing contracts

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Comparison Table: Cladribine and Key Competitors

Parameter	Cladribine	Ocrelizumab	Fingolimod	Siponimod
Administration	Oral (2 courses)	IV infusion	Oral	Oral
Approved Indications	MS, HCL	MS (RRMS, PPMS)	MS	MS
Market Share (2022)	4–6%	30%+	20%+	8–10%
Patent Status	Expiring soon	Under patent protection	Valid until 2025	Valid until 2025
Safety Profile	Lymphopenia, infections	Infusion reactions	Cardiac effects	Cardiac effects

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Key Market Entrants and Future Outlook

• Growth Drivers:

  • Increasing MS prevalence (~2.8 million globally).
  • Preference for oral DMTs.
  • Focus on treatment adherence.

• Risks:

  • Safety concerns, especially infection risks.
  • Patent cliff leading to generic entries.
  • Competitive innovation.

• Strategic Recommendations:

  • Invest in safety profile enhancements.
  • Pursue line extensions.
  • Expand global footprint, especially in emerging markets.
  • Engage in partnerships for pipeline diversification.

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Key Takeaways

• Cladribine exhibits promising growth potential within the expanding MS therapeutic market, propelled by its oral administration, high efficacy, and convenient dosing schedule.
• The approaching patent expiry necessitates lifecycle management strategies, such as formulation improvements and new indications.
• Competitive positioning hinges on safety profile optimization, regulatory facilitation, and expanding access in untapped markets.
• Revenue estimates project compound annual growth rates of approximately 14–20% from 2023 through 2027, contingent on regulatory success and market penetration.
• The hematological application remains niche but stable, with opportunities limited by existing competition and market size.

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FAQs

1. What are the primary factors influencing Cladribine’s market growth?

Market growth hinges on expanding indications, regulatory approvals in new regions, improved safety profiles, pricing strategies, and physician acceptance driven by clinical efficacy and convenience.

2. How does Cladribine compare to other oral MS therapies?

Cladribine offers a shorter treatment course (two annual courses) compared to agents like fingolimod and siponimod, which require ongoing daily dosing. Its efficacy is comparable, but safety profiles and long-term data influence market share.

3. What are the main regulatory challenges facing Cladribine?

Regulatory hurdles relate to safety concerns, especially lymphopenia-related infections, and the need for robust post-market surveillance data to garner approval for broader indications.

4. How does patent expiry impact Cladribine’s future?

Patent expiration, expected around 2024–2025, could lead to generic competitors, pressuring prices and margins. Lifecycle management and line extensions are vital strategies to counteract this.

5. What emerging markets hold potential for Cladribine?

Asia-Pacific, Latin America, and Middle Eastern regions present growth opportunities due to increasing MS awareness, healthcare infrastructure development, and expanding insurance coverage.

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References

[1] Global Multiple Sclerosis Therapeutics Market, 2022 - Fortune Business Insights.
[2] FDA Approval of Mavenclad (2019). U.S. Food and Drug Administration.
[3] EMA Approves Mavenclad for Multiple Sclerosis (2017). European Medicines Agency.
[4] Market Dynamics in Hematological Malignancies - GlobalData, 2022.
[5] Patent & Regulatory Timeline for Cladribine – Pharmacovigilance Reports, 2022.