Fludarabine Phosphate Patent Expiration
Fludarabine Phosphate is Used for treating patients with B-cell chronic lymphocytic leukemia (CLL). It was first introduced by Genzyme Corp
Fludarabine Phosphate Patents
Given below is the list of patents protecting Fludarabine Phosphate, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Oforta | US7148207 | Oral fludara of high-purity formulation with quick release of active ingredient |
Dec 20, 2022
(Expired) | Sanofi Aventis Us |
| Oforta | US7547776 | Process for the production of fludarabine-phosphate lithium, sodium, potassium, calcium and magnesium salts and purification process for the production of fludarabine-phosphate and fludarabine-phosphate with a purity of at least 99.5% |
Dec 10, 2018
(Expired) | Sanofi Aventis Us |
Fludarabine Phosphate's Family Patents
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Clinical Trials
Recent Clinical Trials on Fludarabine Phosphate:
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 |
|---|---|---|---|---|
 | ||||
| Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Thiotepa in Treating Patients With Non-malignant Disorders | Fred Hutchinson Cancer Center | NA |
RECRUITING
(Sep 1, 2026)
| PHASE2 |
| 90Y-DOTA-anti-CD25 Basiliximab, Fludarabine, Melphalan, and Total Marrow and Lymphoid Irradiation for the Treatment of High-Risk Acute Leukemia or Myelodysplastic Syndrome | City of Hope Medical Center | NA |
ACTIVE NOT RECRUITING
(Jul 1, 2026)
| PHASE1 |
| Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant | University of Chicago | NA |
SUSPENDED
(Mar 1, 2026)
| PHASE1 |
| Treosulfan-Based Conditioning Regimen Before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904) | Fred Hutchinson Cancer Center | NA |
COMPLETED
(Mar 1, 2026)
| PHASE2 |