Clofarabine Patent Expiration

Clofarabine is Used for treating pediatric patients aged 1 to 21 years with relapsed or refractory acute lymphoblastic leukemia. It was first introduced by Genzyme Corp in its drug Clolar on Dec 28, 2004. 13 different companies have introduced drugs containing Clofarabine.


Clofarabine Patents

Given below is the list of patents protecting Clofarabine, 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
Clolar US5661136

(Pediatric)

2-halo-2'-fluoro ARA adenosines as antinoplastic agents Jul 14, 2018

(Expired)

Genzyme
Clolar US5661136 2-halo-2'-fluoro ARA adenosines as antinoplastic agents Jan 14, 2018

(Expired)

Genzyme



Clofarabine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Clofarabine:

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
Chimeric Antigen Receptor T-cells for The Treatment of AML Expressing CLL-1 Antigen Baylor College of Medicine NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia City of Hope Medical Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Treosulfan-Based Versus Clofarabine-Based Conditioning Before Donor Hematopoietic Stem Cell Transplant for the Treatment of Myelodysplastic Syndromes or Acute Myeloid Leukemia Fred Hutchinson Cancer Center NA TERMINATED
(Aug 1, 2026)
PHASE2
C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B) Baylor College of Medicine NA RECRUITING
(Jul 1, 2026)
PHASE1
Study of Clofarabine in Patients With Recurrent or Refractory Langerhans Cell Histiocytosis and LCH-related Disorders Dana-Farber Cancer Institute NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
CD30 CAR T Cells, Relapsed CD30 Expressing Lymphoma (RELY-30) Baylor College of Medicine NA RECRUITING
(Jun 1, 2026)
PHASE1
The CLARA Study From the Acute Leukemia French Association (ALFA 0702 Trial) Hospices Civils de Lyon NA COMPLETED
(May 1, 2026)
PHASE2
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations National Cancer Institute (NCI) NA COMPLETED
(May 1, 2026)
PHASE3


Clofarabine Generic API Manufacturers

Several generic applications have been filed for Clofarabine. The first generic version for Clofarabine was by Abon Pharmaceuticals Llc and was approved on May 9, 2017. And the latest generic version is by Scinopharm Taiwan Ltd and was approved on Jan 3, 2025.

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