Istodax

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.

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:
  
  
  • July 6, 2012
    
    ✓ 
    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
    
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    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 - NEW CHEMICAL ENTITY
  
  
  • November 5, 2016 - ORPHAN DRUG EXCLUSIVITY
  
  
  • June 16, 2018 - ORPHAN DRUG EXCLUSIVITY
  
  

See also...

• Istodax Consumer Information (Drugs.com)
• Istodax Consumer Information (Wolters Kluwer)
• Istodax Consumer Information (Cerner Multum)
• Istodax Advanced Consumer Information (Micromedex)
• Istodax AHFS DI Monographs (ASHP)
• Romidepsin Consumer Information (Wolters Kluwer)
• Romidepsin Consumer Information (Cerner Multum)
• Romidepsin Intravenous Advanced Consumer Information (Micromedex)
• Romidepsin AHFS DI Monographs (ASHP)