Cladribine Patent Expiration

Cladribine is used for treating multiple sclerosis (MS) with oral cladribine. It was first introduced by Janssen Pharmaceuticals Inc in its drug Leustatin on Feb 26, 1993. Another drug containing Cladribine is Mavenclad. 8 different companies have introduced drugs containing Cladribine.


Cladribine Patents

Given below is the list of patents protecting Cladribine, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Mavenclad US12533408 Treatment Regimen For The Treatment Of Autoimmune Disorders Sep 10, 2041 Emd Serono Inc
Mavenclad US12539329 Treatment Regimen For The Treatment Of Autoimmune Disorders Sep 10, 2041 Emd Serono Inc
Mavenclad US10849919 Cladribine regimen for treating progressive forms of multiple sclerosis Nov 23, 2038 Emd Serono Inc
Mavenclad US7713947 Cladribine regimen for treating multiple sclerosis Oct 16, 2026 Emd Serono Inc
Mavenclad US8377903 Cladribine regimen for treating multiple sclerosis May 31, 2026

(Expired)

Emd Serono Inc
Mavenclad US7888328 Oral formulations of cladribine Apr 11, 2024

(Expired)

Emd Serono Inc
Mavenclad US8785415 Oral formulations of cladribine Apr 11, 2024

(Expired)

Emd Serono Inc



Cladribine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Cladribine:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/Refractory Hairy Cell Leukemia and Variant National Cancer Institute (NCI) NA RECRUITING
(Sep 14, 2026)
PHASE1
CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia Fred Hutchinson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE1
ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis Queen Mary University of London NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad) Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study of Vemurafenib and Obinutuzumab Compared to Cladribine and Rituximab in People With Hairy Cell Leukemia (HCL) Memorial Sloan Kettering Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE2
Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations M.D. Anderson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE2
The HIt HArd and hiT Early in Multiple Sclerosis Trial Uppsala University NA RECRUITING
(Sep 1, 2026)
PHASE2
A Phase 1 Open-Label, Dose-Ranging Safety and Pharmacokinetics Study of Oral Cladribine in Patients With Acute Myeloid Leukemia (AML) M.D. Anderson Cancer Center NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia M.D. Anderson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Salvage Chemotherapy With Sonrotoclax, Cladribine, and Standard-dose Cytarabine, Sequentially Followed by HSCT for R/R AML. Institute of Hematology & Blood Diseases Hospital, China NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Cladribine Plus Low Dose Cytarabine (LDAC) Alternating With Decitabine in Patients With Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS) M.D. Anderson Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE2
Testing the Combination of Anti-cancer Drugs, Tovorafenib Plus Rituximab, in Patients With Hairy Cell Leukemia National Cancer Institute (NCI) NA RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Cladribine and Rituximab in Treating Patients With Hairy Cell Leukemia M.D. Anderson Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE2
Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome M.D. Anderson Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML University of Maryland, Baltimore NA RECRUITING
(Jun 1, 2026)
PHASE2
Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia M.D. Anderson Cancer Center NA RECRUITING
(May 1, 2026)
PHASE2
Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers M.D. Anderson Cancer Center NA RECRUITING
(May 1, 2026)
PHASE2
CPX-351 or CLAG-M Regimen for the Treatment of Acute Myeloid Leukemia or Other High-Grade Myeloid Neoplasms in Medically Less-Fit Patients Fred Hutchinson Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms University of Washington NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Low Dose Vemurafenib and Rituximab in Hairy Cell Leukemia Scripps Health NA COMPLETED
(Apr 1, 2026)
PHASE2
A Phase 1, Open-Label, Sequential Cross-over, Bioavailability/Bioequivalence Study to Compare the Pharmacokinetics of Oral Cladribine With the Reference Listed Drug, Intravenous Cladribine M.D. Anderson Cancer Center NA TERMINATED
(Apr 1, 2026)
PHASE1
Tagraxofusp and Low-Intensity Chemotherapy for CD123-Positive Relapsed or Refractory AML Stanford University NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
BCL2i CLAG-M in R/R Acute Myeloid Leukemia H. Lee Moffitt Cancer Center and Research Institute NA RECRUITING
(Mar 1, 2026)
PHASE2


Cladribine Generic API Manufacturers

Several generic applications have been filed for Cladribine. The first generic version for Cladribine was by Hikma Pharmaceuticals Usa Inc and was approved on Feb 28, 2000. And the latest generic version is by Hopewell Pharma Ventures Inc and was approved on Mar 27, 2026.

Given below is the list of companies who have filed for Cladribine generic, along with the locations of their manufacturing plants worldwide.


Cladribine News

BioNxt Moves into Commercialization Stage with Worldwide Patent Coverage and U.S. Fast Track Status

24 Mar, 2026

BioNxt Achieves Key EPO Decision to Secure European Patent for Sublingual ... - BioSpace

17 Feb, 2026

Husch Blackwell Achieves Federal Circuit Win for TWi Pharmaceuticals in Hatch-Waxman Case...

29 Jan, 2026

Merck KGaA vs. Hopewell Pharma Ventures, Inc. | Robins Kaplan LLP - JDSupra

28 Jan, 2026

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