Cladribine - Generic Drug Details

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

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

Cladribine has one hundred and fifty-three patent family members in thirty-five countries.

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

Summary for cladribine

International Patents:	153
US Patents:	5
Tradenames:	3
Applicants:	6
NDAs:	6
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	133
Patent Applications:	6,981
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
Institute of Hematology & Blood Diseases Hospital, China	Phase 2
University of Florida	Phase 2
Affiliated Hospital of Nantong University	N/A

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
Norvium Bioscience	CLADRIBINE	cladribine	INJECTABLE;INJECTION	200510-001	Oct 6, 2011		DISCN	No	No
Janssen Pharms	LEUSTATIN	cladribine	INJECTABLE;INJECTION	020229-001	Feb 26, 1993		DISCN	Yes	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
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019		RX	Yes	Yes
Hisun Pharm Hangzhou	CLADRIBINE	cladribine	INJECTABLE;INJECTION	210856-001	Nov 25, 2019	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
Emd Serono Inc	MAVENCLAD	cladribine	TABLET;ORAL	022561-001	Mar 29, 2019

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/004230 Treatment 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/000504 Litak 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
Poland	1608344
Taiwan	201936199	CLADRIBINE regimen for treating progressive forms of multiple sclerosis
Portugal	3332789
Japan	5795456
Japan	2013216664	CLADRIBINE REGIMEN FOR TREATING MULTIPLE SCLEROSIS
Hong Kong	1089654	ORAL FORMULATIONS OF CLADRIBINE

Supplementary Protection Certificates for cladribine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1827461	132018000000141	Italy		PRODUCT NAME: CLADRIBINA(MAVENCLAD); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1212, 20170824
1608344	PA2018502,C1608344	Lithuania		PRODUCT NAME: KLADRIBINAS; REGISTRATION NO/DATE: EU1/17/1212/001-006 20170822
1827461	2018C/010	Belgium		PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
1608344	C20180007 00334	Estonia		PRODUCT NAME: KLADRIBIIN;REG NO/DATE: EU/1/17/1212 24.08.2017
1608344	LUC00065	Luxembourg		PRODUCT NAME: CLADRIBINE; AUTHORISATION NUMBER AND DATE: EU/1/17/1212 20170824
1608344	C 2018 009	Romania		PRODUCT NAME: CLADRIBINA; NATIONAL AUTHORISATION NUMBER: EU/1/17/1212; DATE OF NATIONAL AUTHORISATION: 20170822; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1212; DATE OF FIRST AUTHORISATION IN EEA: 20170822

Cladribine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cladribine

Introduction

Cladribine, a potent chemotherapeutic agent, has been gaining significant traction in the pharmaceutical market, particularly for the treatment of multiple sclerosis (MS) and various types of leukemia. Here, we delve into the market dynamics and financial trajectory of cladribine, highlighting key factors driving its growth and potential challenges.

Market Size and Projections

The global cladribine market is experiencing robust growth. As of 2023, the market size was valued at USD 1 billion and is projected to reach USD 2.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 15% from 2024 to 2031[1][4].

Key Drivers of Market Growth

Increasing Prevalence of Hematologic Malignancies and Multiple Sclerosis

The rising incidence of hematologic malignancies such as leukemia and lymphoma, along with the growing number of MS cases, is a significant driver of the cladribine market. Approximately 2.3 million people worldwide live with MS, with the highest prevalence in North America and Europe[3][4].

Regulatory Approvals and Therapeutic Guidelines

Regulatory approvals in various regions, including the United States, Europe, and Australia, have significantly boosted the market. Cladribine's inclusion in therapeutic guidelines for treating relapsing forms of MS has further increased its demand[1][4].

Advancements in Pharmaceutical Research and Development

Ongoing clinical research and development initiatives are enhancing the efficacy and safety profiles of cladribine formulations. New developments, such as sublingual dosage forms, are expected to improve patient compliance and address specific needs like dysphagia in MS patients[3].

Growing Healthcare Spending and Infrastructure

Increasing healthcare spending and the development of healthcare infrastructure in emerging countries are also driving the market growth. Advanced diagnostic tools and treatment facilities in regions like North America support the adoption of cladribine[1][4].

Market Segmentation

By Type

The cladribine market is segmented into various forms, including tablets, injectable, lyophilized powder, oral solution, and pre-filled syringes. Each form caters to different patient needs and preferences, contributing to the overall market growth[1].

By Application

The primary applications of cladribine include hairy cell leukemia, multiple sclerosis, lymphoma, chronic lymphocytic leukemia, and acute myeloid leukemia. The MS segment dominates the market due to the high prevalence of the disease and the effectiveness of cladribine in treating relapsing forms of MS[1][4].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America accounts for the highest market share due to the high prevalence of MS and advanced healthcare infrastructure[1][4].

Financial Impact and Budget Analysis

Cost Savings and Budget Impact

The introduction of cladribine tablets has been shown to result in significant cost savings. A budget impact analysis indicated that the use of cladribine tablets could lead to savings of 5.0% to 21.5% in the overall budget over a period of five years[2].

Revenue and Sales

Cladribine tablets have already achieved substantial sales, with annual sales exceeding USD 1 billion in 2023. This revenue is expected to grow as the market expands and new formulations, such as sublingual cladribine, gain approval and acceptance[3].

Challenges and Restraints

Adverse Effects and Safety Concerns

Despite its efficacy, cladribine is associated with serious adverse effects, including potential malignancies, severe immunosuppression, and increased risk of infections. These safety concerns can limit its use and reduce market demand[4].

Competitive Landscape

The market is competitive, with several key players such as Merck & Co., Teva Pharmaceuticals, Sanofi, and Pfizer. New entrants, like BioNxt, are also making significant strides with innovative formulations, which could alter the market dynamics[1][3].

Future Outlook and Opportunities

New Formulations and Delivery Systems

The development of new formulations, such as sublingual cladribine, is expected to provide significant advantages, especially for patients with dysphagia. BioNxt's sublingual cladribine program is a notable example, with positive results from animal studies and plans for human clinical trials in 2025[3].

Expansion into Other Indications

Cladribine is being investigated for its potential use in other autoimmune diseases and cancers, such as systemic lupus erythematosus and rheumatoid arthritis. This expansion could further boost the market[4].

Personalized Medicine and Precision Therapies

The increasing focus on personalized medicine and precision therapies is an opportunistic factor for the growth of the cladribine market. Cladribine's ability to target specific immune cells makes it a prime candidate for personalized treatment approaches[4].

Key Takeaways

• The global cladribine market is projected to grow significantly, driven by the increasing prevalence of MS and hematologic malignancies.
• Regulatory approvals and advancements in pharmaceutical research are key drivers of market growth.
• New formulations, such as sublingual cladribine, are expected to enhance patient compliance and address specific needs.
• Despite its growth potential, the market faces challenges related to adverse effects and safety concerns.
• The market is competitive, with several key players and new entrants innovating in the space.

FAQs

1. What is the projected market size of the global cladribine market by 2031?

   • The global cladribine market is expected to reach USD 2.5 billion by 2031, growing at a CAGR of 15% from 2024 to 2031[1].

2. What are the primary applications of cladribine?

   • The primary applications of cladribine include hairy cell leukemia, multiple sclerosis, lymphoma, chronic lymphocytic leukemia, and acute myeloid leukemia[1].

3. Which region dominates the cladribine market?

   • North America accounts for the highest market share due to the high prevalence of MS and advanced healthcare infrastructure[1][4].

4. What are the potential adverse effects associated with cladribine?

   • Cladribine is associated with serious adverse effects, including potential malignancies, severe immunosuppression, and increased risk of infections[4].

5. What new formulations are being developed for cladribine?

   • BioNxt is developing a sublingual cladribine formulation, which has shown positive results in animal studies and is planned for human clinical trials in 2025[3].

Sources

1. Market Research Intellect - Cladribine Market Size and Projections[1]
2. PubMed - Economic evaluation of cladribine tablets in high disease activity[2]
3. BioSpace - BioNxt Provides Update on Cladribine Program for Multiple Sclerosis[3]
4. Market Statsville Group - Cladribine Market Size Share Growth Analysis Scope 2033[4]