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Halaven patents expiration

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6214865 EISAI INC Macrocyclic analogs and methods of their use and preparation
Jul, 2023

(9 months ago)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6469182 EISAI INC Intermediates in the preparation of macrocyclic analogs
Jun, 2019

(4 years ago)

US7470720 EISAI INC Methods and compositions for use in treating cancer
Jun, 2019

(4 years ago)

US8097648 EISAI INC Methods and compositions for use in treating cancer
Jan, 2021

(3 years ago)

US6214865

(Pediatric)

EISAI INC Macrocyclic analogs and methods of their use and preparation
Jan, 2024

(3 months ago)

USRE46965 EISAI INC Intermediates for the preparation of analogs of Halichondrin B
Jan, 2027

(2 years from now)

USRE46965

(Pediatric)

EISAI INC Intermediates for the preparation of analogs of Halichondrin B
Jul, 2027

(3 years from now)

Halaven is owned by Eisai Inc.

Halaven contains Eribulin Mesylate.

Halaven has a total of 7 drug patents out of which 5 drug patents have expired.

Expired drug patents of Halaven are:

  • US6469182
  • US7470720
  • US8097648
  • US6214865*PED
  • US6214865

Halaven was authorised for market use on 15 November, 2010.

Halaven is available in solution;intravenous dosage forms.

Halaven can be used as treatment of patients with metastatic breast cancer.

Drug patent challenges can be filed against Halaven from 13 March, 2025.

The generics of Halaven are possible to be released after 08 July, 2027.

Drug Exclusivity Drug Exclusivity Expiration
M(M-280) Sep 13, 2025
Pediatric Exclusivity(PED) Mar 13, 2026
New Indication(I-721) Jan 28, 2019
Orphan Drug Exclusivity(ODE) Jan 28, 2023
Orphan Drug Exclusivity(ODE-107) Jan 28, 2023
New Chemical Entity Exclusivity(NCE) Nov 15, 2015

Drugs and Companies using ERIBULIN MESYLATE ingredient

NCE-1 date: 13 March, 2025

Market Authorisation Date: 15 November, 2010

Treatment: Treatment of patients with metastatic breast cancer

Dosage: SOLUTION;INTRAVENOUS

How can I launch a generic of HALAVEN before it's drug patent expiration?
More Information on Dosage

HALAVEN family patents

Family Patents