Generic Tibsovo Availability

Last updated on Nov 7, 2023.

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.

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.

Pharmaceutical compositions of therapeutically active compounds
Patent 10,449,184
Issued: October 22, 2019
Inventor(s): Gu Chong-Hui
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
  ✓
  Drug product
Methods and compositions for cell-proliferation-related disorders
Patent 10,610,125
Issued: April 7, 2020
Inventor(s): Dang Lenny & Fantin Valeria & Gross Stefan & Jang Hyun Gyung & Jin Shengfang & Salituro Francesco G. & Saunders Jeffrey O. & Su Shin-San Michael & Yen Katharine
Assignee(s): Agios Pharmaceuticals, Inc.
Methods of treating and evaluating subjects having neoactive mutants are described herein.
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)
Combination therapy for treating malignancies
Patent 10,653,710
Issued: May 19, 2020
Inventor(s): Agresta Samuel V. & Viswanadhan Krishnan & DiMartino Jorge & Chopra Vivek Saroj Kumar & MacBeth Kyle J. & Knight Robert Douglas & Kenvin Laurie & Xu Qiang
Provided are methods and compositions for treating hematological malignancies in patients carrying an IDH1 mutation using a combination of an inhibitor of mutant IDH1 enzyme, (S)-N-((S)-1-(2-chlorophenyl)-2-((3,3-difluorocyclobutyl)amino)-2-oxoethyl)-1-(4-cyanopyridin-2-yl)-N-(5-fluoropyridin-3-yl)-5-oxopyrrolidine-2-carboxamide, or a pharmaceutically acceptable salt thereof (COMPOUND 2) and a DNA demethylating agent.
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
Therapeutically active compounds and their methods of use
Patent 10,717,764
Issued: July 21, 2020
Inventor(s): Popovici-Muller Janeta & Lemieux Rene M. & Travins Jeremy & Cai Zhenwei & Cui Dawei & Zhou Ding
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 PREVIOUSLY TREATED, LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA CHARACTERIZED BY AN IDH1 MUTATION
Pharmaceutical compositions of therapeutically active compounds
Patent 10,799,490
Issued: October 13, 2020
Inventor(s): Gu Chong-Hui
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 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
Issued: November 30, -0001
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
Inventor(s): Lemieux Rene M. & Popovici-Muller Janeta & Travins Jeremy & Cai Zhenwei & Cui Dawei & Zhou Ding
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
Inventor(s): Popovici-Muller Janeta & Lemieux Rene M. & Travins Jeremy & Cai Zhenwei & Cui Dawei & Zhou Ding
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
Inventor(s): Gu Chong-Hui
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:
- 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 OF NEWLY 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
- 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

More about Tibsovo (ivosidenib)

Patient resources

Tibsovo drug information

Professional resources

Tibsovo prescribing information

Related treatment guides

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.

Medical Disclaimer