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Generic Turalio Availability

Medically reviewed by Drugs.com. Last updated on May 11, 2021.

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

TURALIO (pexidartinib hydrochloride - capsule;oral)

  • Manufacturer: DAIICHI SANKYO INC
    Approval date: August 2, 2019
    Strength(s): EQ 200MG BASE [RLD]

Has a generic version of Turalio been approved?

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

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

  • Solid forms of a compound modulating kinases
    Patent 10,189,833
    Issued: January 29, 2019
    Assignee(s): Plexxikon Inc.

    Solid forms of the compound, [5-(5-chloro-1H-pyrrolo[2,3-b]pyridin-3-ylmethyl)-pyridin-2-yl]-(6-trifluoromethyl-pyridin-3-ylmethyl)-amine HCl salt (Compound I) and its free base, active on the receptor protein kinases c-Kit and/or c-Fms and/or Flt3, were prepared and characterized: Also provided are methods of using the solid forms.

    Patent expiration dates:

    • May 5, 2036
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH SYMPTOMATIC TENOSYNOVIAL GIANT CELL TUMOR (TGCT) ASSOCIATED WITH SEVERE MORBIDITY OR FUNCTIONAL LIMITATIONS AND NOT AMENABLE TO IMPROVEMENT WITH SURGERY
  • Patent 10,435,404

    Patent expiration dates:

    • July 24, 2038
      ✓ 
      Drug product
  • Patent 10,730,876

    Patent expiration dates:

    • May 5, 2036
      ✓ 
      Drug substance
  • Patent 10,941,142

    Patent expiration dates:

    • July 24, 2038
      ✓ 
      Drug product
  • Patent 10,961,240

    Patent expiration dates:

    • July 24, 2038
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH SYMPTOMATIC TENOSYNOVIAL GIANT CELL TUMOR (TGCT) ASSOCIATED WITH SEVERE MORBIDITY OR FUNCTIONAL LIMITATIONS AND NOT AMENABLE TO IMPROVEMENT WITH SURGERY
  • Compounds modulating c-fms and/or c-kit activity and uses therefor
    Patent 7,893,075
    Issued: February 22, 2011
    Inventor(s): Zhang; Jiazhong & Ibrahim; Prabha N. & Artis; Dean R. & Bremer; Ryan & Wu; Guoxian & Zhu; Hongyao & Nespi; Marika & Zhang; Chao
    Assignee(s): Plexxikon, Inc.

    Compounds active on the receptor protein tyrosine kinases c-kit and/or c-fms are provided herewith. Also provided herewith are compositions useful for treatment of c-kit mediated diseases or conditions and/or c-fms-mediated diseases or conditions, and methods for the use thereof.

    Patent expiration dates:

    • October 13, 2028
      ✓ 
      Drug substance
  • Compounds modulating c-fms and/or c-kit activity and uses therefor
    Patent 8,404,700
    Issued: March 26, 2013
    Assignee(s): Plexxikon Inc.

    Compounds active on the receptor protein tyrosine kinases c-kit and/or c-fms are provided herewith. Also provided herewith are compositions useful for treatment of c-kit mediated diseases or conditions and/or c-fms-mediated diseases or conditions, and methods for the use thereof.

    Patent expiration dates:

    • November 21, 2027
      ✓ 
      Drug substance
  • Compounds modulating c-fms and/or c-kit activity
    Patent 8,461,169
    Issued: June 11, 2013
    Assignee(s): Plexxikon Inc.

    Compounds active on the receptor protein tyrosine kinases c-kit and/or c-fms are provided herewith. Also provided herewith are compositions useful for treatment of c-kit mediated diseases or conditions and/or c-fms-mediated diseases or conditions, and methods for the use thereof.

    Patent expiration dates:

    • April 19, 2028
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH SYMPTOMATIC TENOSYNOVIAL GIANT CELL TUMOR (TGCT) ASSOCIATED WITH SEVERE MORBIDITY OR FUNCTIONAL LIMITATIONS AND NOT AMENABLE TO IMPROVEMENT WITH SURGERY
  • Compounds modulating c-fms and/or c-kit activity and uses therefor
    Patent 8,722,702
    Issued: May 13, 2014
    Assignee(s): Plexxikon Inc.

    Compounds active on the receptor protein tyrosine kinases c-kit and/or c-fms are provided herewith. Also provided herewith are compositions useful for treatment of c-kit mediated diseases or conditions and/or c-fms-mediated diseases or conditions, and methods for the use thereof.

    Patent expiration dates:

    • November 21, 2027
      ✓ 
      Drug substance
  • Compounds modulating c-fms and/or c-kit activity and uses therefor
    Patent 9,169,250
    Issued: October 27, 2015
    Assignee(s): Plexxikon Inc.

    Compounds active on the receptor protein tyrosine kinases c-kit and/or c-fms are provided herewith. Also provided herewith are compositions useful for treatment of c-kit mediated diseases or conditions and/or c-fms-mediated diseases or conditions, and methods for the use thereof.

    Patent expiration dates:

    • November 21, 2027
      ✓ 
      Drug substance
  • Kinase modulation, and indications therefor
    Patent 9,358,235
    Issued: June 7, 2016
    Assignee(s): Plexxikon Inc.

    The present disclosure provides methods of using protein kinase inhibitors for treating diseases and conditions, including diseases and conditions associated with activity of any protein kinase selected from Fms protein kinase including any mutations thereof, Kit protein kinase any mutations thereof, Flt-3 protein kinase any mutations thereof and combinations thereof.

    Patent expiration dates:

    • June 8, 2033
      ✓ 
      Patent use: TREATMENT OF ADULT PATIENTS WITH SYMPTOMATIC TENOSYNOVIAL GIANT CELL TUMOR (TGCT) ASSOCIATED WITH SEVERE MORBIDITY OR FUNCTIONAL LIMITATIONS AND NOT AMENABLE TO IMPROVEMENT WITH SURGERY
  • Patent 9,802,932

    Patent expiration dates:

    • May 5, 2036
      ✓ 
      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:

    • August 2, 2024 - NEW CHEMICAL ENTITY
    • August 2, 2026 -

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.