Eribulin Mesylate Patent Expiration

Eribulin Mesylate is Used for treating patients with metastatic breast cancer. It was first introduced by Eisai Inc in its drug Halaven on Nov 15, 2010. 11 different companies have introduced drugs containing Eribulin Mesylate.


Eribulin Mesylate Patents

Given below is the list of patents protecting Eribulin Mesylate, 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
Halaven USRE46965

(Pediatric)

Intermediates for the preparation of analogs of Halichondrin B Jul 08, 2027 Eisai Inc
Halaven USRE46965 Intermediates for the preparation of analogs of Halichondrin B Jan 08, 2027 Eisai Inc
Halaven US6214865

(Pediatric)

Macrocyclic analogs and methods of their use and preparation Jan 20, 2024

(Expired)

Eisai Inc
Halaven US8097648 Methods and compositions for use in treating cancer Jan 22, 2021

(Expired)

Eisai Inc
Halaven US6214865 Macrocyclic analogs and methods of their use and preparation Jun 16, 2019

(Expired)

Eisai Inc
Halaven US6469182 Intermediates in the preparation of macrocyclic analogs Jun 16, 2019

(Expired)

Eisai Inc
Halaven US7470720 Methods and compositions for use in treating cancer Jun 16, 2019

(Expired)

Eisai Inc



Eribulin Mesylate's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Eribulin Mesylate:

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
A Study of AL58805 in Advanced, Metastatic GYN, STS or Breast Cancers Advenchen Pharmaceuticals, LLC. NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Atezolizumab With or Without Eribulin Mesylate in Treating Patients With Recurrent Locally Advanced or Metastatic Urothelial Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE1, PHASE2
Eribulin and Radiation Therapy in Treating Patients With Retroperitoneal Liposarcoma That Can Be Removed by Surgery OHSU Knight Cancer Institute NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
A Multicenter, Single-Arm, Phase II Exploratory Study of Eribulin in Combination With Anlotinib for HER2-Negative Recurrent/Metastatic Breast Cancer Previously Treated With Antibody-Drug Conjugates Sun Yat-sen University NA RECRUITING
(Apr 1, 2026)
PHASE2


Eribulin Mesylate Generic API Manufacturers

Several generic applications have been filed for Eribulin Mesylate. The first generic version for Eribulin Mesylate was by Gland Pharma Ltd and was approved on Apr 5, 2024. And the latest generic version is by Natco Pharma Ltd and was approved on Jun 1, 2026.

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