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Generic Halaven Availability

Halaven is a brand name of eribulin, approved by the FDA in the following formulation(s):

HALAVEN (eribulin mesylate - solution;intravenous)

  • Manufacturer: EISAI INC
    Approval date: November 15, 2010
    Strength(s): 1MG/2ML (0.5MG/ML) [RLD]

Has a generic version of Halaven been approved?

No. There is currently no therapeutically equivalent version of Halaven available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Halaven. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.

Related Patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Macrocyclic analogs and methods of their use and preparation
    Patent 6,214,865
    Issued: April 10, 2001
    Inventor(s): Littlefield; Bruce A. & Palme; Monica H. & Seletsky; Boris M. & Towle; Murray J. & Yu; Melvin J. & Zheng; Wanjun
    Assignee(s): Eisai Co., Ltd.
    The invention provides halichondrin analogs having pharmaceutical activity, such as anticancer or antimitotic (mitosis-blocking) activity, and methods of identifying agents that induce a sustained mitotic block in a cell after transient exposure of the cell to the agents.
    Patent expiration dates:
    • July 20, 2023
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      Drug substance
  • Intermediates in the preparation of macrocyclic analogs
    Patent 6,469,182
    Issued: October 22, 2002
    Inventor(s): Bruce A.; Littlefield & Monica H.; Palme & Boris M.; Seletsky & Murray J.; Towle & Melvin J.; Yu & Wanjun; Zheng
    Assignee(s): Eisai Co., Ltd.
    Novel intermediates of the formula They are used in the preparation of macrocyclic analogs.
    Patent expiration dates:
    • June 16, 2019
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      Patent use: TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA
    • June 16, 2019
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      Patent use: TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER
  • Methods and compositions for use in treating cancer
    Patent 7,470,720
    Issued: December 30, 2008
    Inventor(s): Littlefield; Bruce A. & Towle; Murray J.
    Assignee(s): Eisai R&D Management Co., Ltd.
    The invention provides methods and compositions for use in treating diseases associated with excessive cellular proliferation, such as cancer.
    Patent expiration dates:
    • June 16, 2019
      ✓ 
      Drug product
  • Methods and compositions for use in treating cancer
    Patent 8,097,648
    Issued: January 17, 2012
    Inventor(s): Littlefield; Bruce A. & Towle; Murray J. & Seletsky; Boris M. & Yu; Melvin J. & Zheng; Wanjun
    Assignee(s): Eisai R&D Management Co., Ltd.
    The invention provides methods and compositions for use in treating diseases associated with excessive cellular proliferation, such as cancer.
    Patent expiration dates:
    • January 22, 2021
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • November 15, 2015 - NEW CHEMICAL ENTITY
    • January 28, 2019 - TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC LIPOSARCOMA WHO HAVE RECEIVED A PRIOR ANTHRACYCLINE-CONTAINING REGIMEN.
    • January 28, 2023 - ORPHAN DRUG EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
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