Generic Istodax Availability

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

ISTODAX (romidepsin - powder;iv (infusion))

  • Manufacturer: CELGENE
    Approval date: November 5, 2009
    Strength(s): 10MG/VIAL [RLD]

Has a generic version of Istodax been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Istodax. 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.

  • FR901228 substance and preparation thereof
    Patent 4,977,138
    Issued: December 11, 1990
    Inventor(s): Okuhara; Masakuni & Goto; Toshio & Hori; Yasuhiro & Fujita; Takashi & Ueda; Hirotsugu & Shigematsu; Nobuharu
    Assignee(s): Fujisawa Pharmaceutical Co., Ltd.
    The invention relates to a compound having antimicrobial and antitumor activity, the compound being designated FR901228 substance of the following formula: ##STR1##
    Patent expiration dates:
    • August 22, 2013
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Method of producing FR901228
    Patent 7,608,280
    Issued: October 27, 2009
    Inventor(s): Ueda; Satoshi & Watamoto; Yoko & Tsuboi; Masaru & Kanda; Munekazu & Higaki; Tomoji & Matsuda; Mitsunori
    Assignee(s): Astellas Pharma Inc.
    Depsipeptides and congeners thereof are disclosed having structure (I), wherein m, n, p, q, X, R1, R2 and R3 are as defined herein. These compounds, including FR901228, have activity as, for example, immunosuppressants, as well as for the prevention or treatment of patients suffering or at risk of suffering from inflammatory, autoimmune or immune system-related diseases including graft-versus-host disease and enhancement of graft/tissue survival following transplant. Also provided are methods for inhibiting lymphocyte activation, proliferation, and/or suppression of IL-2 secretion. Also provided are crystalline forms of FR901228, e.g., type A and type B crystalline forms of FR901228.
    Patent expiration dates:
    • August 22, 2021
      ✓ 
      Drug substance
  • Method of producing FR901228
    Patent 7,611,724
    Issued: November 3, 2009
    Inventor(s): Ueda; Satoshi & Watamoto; Yoko & Tsuboi; Masaru & Kanda; Munekazu & Higaki; Tomoji & Matsuda; Mitsunori
    Assignee(s): Astellas Pharma Inc.
    Depsipeptides and congeners thereof are disclosed having structure (I), wherein m, n, p, q, X, R1, R2 and R3 are as defined herein. These compounds, including FR901228, have activity as, for example, immunosuppressants, as well as for the prevention or treatment of patients suffering or at risk of suffering from inflammatory, autoimmune or immune system-related diseases including graft-versus-host disease and enhancement of graft/tissue survival following transplant. Also provided are methods for inhibiting lymphocyte activation, proliferation, and/or suppression of IL-2 secretion. Also provided are crystalline forms of FR901228, e.g., type A and type B crystalline forms of FR901228.
    Patent expiration dates:
    • August 22, 2021
      ✓ 
      Drug substance

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 5, 2014 -
    • November 5, 2016 -
    • June 16, 2018 -

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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