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Generic Tibsovo Availability

Last updated on Sep 8, 2022.

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

TIBSOVO (ivosidenib - tablet;oral)

  • Manufacturer: SERVIER
    Approval date: July 20, 2018
    Strength(s): 250MG [RLD]

Has a generic version of Tibsovo been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tibsovo. 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: Generic Drug FAQ.

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.

  • Patent 10,449,184

    Patent expiration dates:

    • March 13, 2035
      ✓ 
      Drug product
  • Patent 10,610,125

    Patent expiration dates:

    • June 21, 2030
      ✓ 
      Patent use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) AND WHERE THE MUTANT IDH1 HAS THE ABILITY TO CONVERT ALPHA-KETOGLUTARATE INTO 2-HYDROXYGLUTARATE (2-HG)
    • June 21, 2030
      ✓ 
      Patent use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) AND WHERE THE MUTANT IDH1 HAS THE ABILITY TO CONVERT ALPHA-KETOGLUTARATE INTO 2-HYDROXYGLUTARATE (2-HG)
    • June 21, 2030
      ✓ 
      Patent use: A METHOD FOR TREATING NEWLY DIAGNOSED AML WITH IVOSIDENIB AND AZACITIDINE WHEREIN THE AML HAS AN IDH1 MUTATION CAPABLE OF CONVERTING ALPHA-KETOGLUTARATE TO 2-HYDROXYGLUTARATE (2HG)
  • Patent 10,653,710

    Patent expiration dates:

    • October 18, 2036
      ✓ 
      Patent use: A METHOD FOR TREATING NEWLY DIAGNOSED AML CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 SELECTED FROM R132H, R132C, R132L, R132V, R132S AND R132GF BY ADMINISTERING IVOSIDENIB AND AZACITIDINE
  • Patent 10,717,764

    Patent expiration dates:

    • January 18, 2033
      ✓ 
      Patent use: A METHOD OF TREATING PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA CHARACTERIZED BY AN IDH1 MUTATION
  • Patent 10,799,490

    Patent expiration dates:

    • March 13, 2035
      ✓ 
      Patent use: A METHOD FOR TREATING AML BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING IVOSIDENIB WHEREIN THE AML IS NEWLY DIAGNOSED AND CHARACTERIZED BY A MUTANT IDH1 AND THE COMPOSITION IS ADMINISTERED IN COMBINATION WITH AZACITIDINE
      ✓ 
      Drug product
    • March 13, 2035
      ✓ 
      Patent use: A METHOD OF TREATING ACUTE MYELOGENOUS LEUKEMIA (AML) IN A SUBJECT BY ADMINISTERING A PHARMACEUTICAL COMPOSITION WHERE THE AML IS CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 AND THE AML IS NEWLY DIAGNOSED
      ✓ 
      Drug product
    • March 13, 2035
      ✓ 
      Patent use: A METHOD OF TREATING ACUTE MYELOGENOUS LEUKEMIA (AML) IN A SUBJECT BY ADMINISTERING A PHARMACEUTICAL COMPOSITION WHERE THE AML IS CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 AND WHERE THE AML IS RELAPSED/REFRACTORY
      ✓ 
      Drug product
  • Patent 10,980,788

    Patent expiration dates:

    • June 7, 2039
      ✓ 
      Patent use: A METHOD OF TREATING PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL
    • June 7, 2039
      ✓ 
      Patent use: TREATING NEWLY DIAGNOSED AML CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE OF IVOSIDENIB TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL, IN COMBINATION WITH AZACITIDINE
    • June 7, 2039
      ✓ 
      Patent use: TREATING NEWLY DIAGNOSED ACUTE MYELOGENOUS LEUKEMIA (AML) CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL
    • June 7, 2039
      ✓ 
      Patent use: TREATING RELAPSED/REFRACTORY ACUTE MYELOGENOUS LEUKEMIA (AML) CHARACTERIZED BY THE PRESENCE OF A MUTANT ALLELE OF IDH1 BY ADMINISTERING A ONCE DAILY 500 MG ORAL DOSE TO A SUBJECT THAT HAS NOT INGESTED A HIGH-FAT MEAL
  • Therapeutically active compositions and their methods of use
    Patent 9,474,779
    Issued: October 25, 2016
    Assignee(s): Agios Pharmaceuticals, Inc.

    Provided are methods of treating a cancer characterized by the presence of a mutant allele of IDH1/2 comprising administering to a subject in need thereof a compound described here.

    Patent expiration dates:

    • August 19, 2033
      ✓ 
      Patent use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML)
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • August 19, 2033
      ✓ 
      Patent use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML)
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • August 19, 2033
      ✓ 
      Patent use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS ACUTE MYELOGENOUS LEUKEMIA (AML)
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • August 19, 2033
      ✓ 
      Patent use: A METHOD FOR TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WITH IVOSIDENIB IN COMBINATION WITH AZACITIDINE WHEREIN THE CANCER IS NEWLY DIAGNOSED AML
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • August 19, 2033
      ✓ 
      Patent use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHEREIN THE CANCER IS PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Therapeutically active compositions and their methods of use
    Patent 9,850,277
    Issued: December 26, 2017
    Assignee(s): AGIOS PHARMACEUTICALS, INC.

    Provided are methods of treating a cancer characterized by the presence of a mutant allele of IDH1/2 comprising administering to a subject in need thereof a compound described here.

    Patent expiration dates:

    • January 18, 2033
      ✓ 
      Patent use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML)
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • January 18, 2033
      ✓ 
      Patent use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS ACUTE MYELOGENOUS LEUKEMIA (AML)
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • January 18, 2033
      ✓ 
      Patent use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML)
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • January 18, 2033
      ✓ 
      Patent use: A METHOD FOR TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WITH IVOSIDENIB IN COMBINATION WITH AZACITIDINE WHEREIN THE CANCER IS NEWLY DIAGNOSED AML
      ✓ 
      Drug substance
      ✓ 
      Drug product
    • January 18, 2033
      ✓ 
      Patent use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHEREIN THE CANCER IS PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA
      ✓ 
      Drug substance
      ✓ 
      Drug product
  • Pharmaceutical compositions of therapeutically active compounds
    Patent 9,968,595
    Issued: May 15, 2018
    Assignee(s): AGIOS PHARMACEUTICALS, INC.

    Provided are compounds and pharmaceutical compositions useful for treating cancer and methods of treating cancer comprising administering to a subject in need thereof a compound or pharmaceutical composition described herein.

    Patent expiration dates:

    • March 13, 2035
      ✓ 
      Patent use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML)
      ✓ 
      Drug product
    • March 13, 2035
      ✓ 
      Patent use: A METHOD OF TREATING A CANCER CHARACTERIZED BY AN IDH1 MUTATION WHERE THE CANCER IS RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML)
      ✓ 
      Drug product
    • March 13, 2035
      ✓ 
      Patent use: TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) WITH AN IDH1 MUTATION
      ✓ 
      Drug product
    • March 13, 2035
      ✓ 
      Patent use: A METHOD FOR TREATING AML BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING IVOSIDENIB WHEREIN THE AML IS NEWLY DIAGNOSED AND CHARACTERIZED BY A MUTANT IDH1 AND THE COMPOSITION IS ADMINISTERED IN COMBINATION WITH AZACITIDINE
      ✓ 
      Drug product

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:

    • May 2, 2022 - TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WHO ARE >= 75 YEARS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
    • July 20, 2023 - NEW CHEMICAL ENTITY
    • August 25, 2024 - FOR THE TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH AN IDH1 MUTATION AS DETECTED BY AN FDA-APPROVED TEST
    • May 25, 2025 - IN COMBINATION WITH AZACITIDINE OR AS MONOTHERAPY FOR THE TREATMENT OFNEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST IN ADULTS 75 YEARS OR OLDER, OR WHO HAVE C
    • July 20, 2025 - INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST
    • May 2, 2026 - TX OF NEWLY-DIAGNOSED ACUTE MYELOID LEUKEMIA WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 MUTATION AS DETECTED BY AN FDA-APPROVED TEST IN ADULT PTS WHO ARE >=75 YRS OLD OR WHO HAVE COMORBIDITIES THAT PRECLUDE USE OF INTENSIVE INDUCTION CHEMOTHERAPY
    • August 25, 2028 - TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH AN ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.