Generic Turalio Availability
Last updated on Jan 8, 2025.
Turalio is a brand name of pexidartinib, approved by the FDA in the following formulation(s):
TURALIO (pexidartinib hydrochloride - capsule;oral)
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Manufacturer: DAIICHI SANKYO INC
Approval date: August 2, 2019
Strength(s): EQ 200MG BASE (discontinued) [RLD] -
Manufacturer: DAIICHI SANKYO INC
Approval date: October 14, 2022
Strength(s): EQ 125MG 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.
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Solid forms of a compound modulating kinases
Patent 10,189,833
Issued: January 29, 2019
Inventor(s): Ibrahim Prabha N. & Visor Gary Conard
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:
Patent expiration dates:
- May 5, 2036✓
- May 5, 2036
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Formulations of a compound modulating kinases
Patent 10,435,404
Issued: October 8, 2019
Inventor(s): Ibrahim Prabha N. & Rezaei Hamid & Visor Gary Conard & Kamo Tomoari & Yamakose HiroshiProvided are compositions comprising Compound I having the following structure:
Patent expiration dates:
- July 24, 2038✓
- July 24, 2038
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Synthesis of a compound that modulates kinases
Patent 10,730,876
Issued: August 4, 2020
Inventor(s): Ibrahim Prabha N. & Jin Masayoshi & Matsuura ShinjiThe present disclosure provides processes for the preparation of a compound of formula I:
Patent expiration dates:
- May 5, 2036✓
- May 5, 2036
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Patent 10,941,142
Patent expiration dates:
- July 24, 2038✓
- July 24, 2038
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Formulations of a compound modulating kinases
Patent 10,961,240
Issued: March 30, 2021
Inventor(s): Ibrahim Prabha N. & Rezaei Hamid & Visor Gary Conard & Kamo Tomoari & Yamakose HiroshiProvided are compositions comprising Compound I having the following structure:
Patent expiration dates:
- July 24, 2038✓
- July 24, 2038
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Patent 7,893,075
Patent expiration dates:
- May 4, 2033✓
- May 4, 2033
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Compounds modulating c-fms and/or c-kit activity and uses therefor
Patent 8,404,700
Issued: March 26, 2013
Inventor(s): Ibrahim Prabha N. & Artis Dean R. & Bremer Ryan & Wu Guoxian & Zhu Hongyao & Nespi Marika & Zhang Chao & Zhang Jiazhong
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✓
- November 21, 2027
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Compounds modulating c-fms and/or c-kit activity
Patent 8,461,169
Issued: June 11, 2013
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:
- April 19, 2028✓
- April 19, 2028
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Compounds modulating c-fms and/or c-kit activity and uses therefor
Patent 8,722,702
Issued: May 13, 2014
Inventor(s): Zhang Jiazhong & Ibrahim Prabha N. & Artis Dean R. & Bremer Ryan & Wu Guoxian & 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:
- November 21, 2027✓
- November 21, 2027
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Compounds modulating c-fms and/or c-kit activity and uses therefor
Patent 9,169,250
Issued: October 27, 2015
Inventor(s): Zhang Jiazhong & Ibrahim Prabha N. & Bremer Ryan
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✓
- November 21, 2027
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Kinase modulation, and indications therefor
Patent 9,358,235
Issued: June 7, 2016
Inventor(s): Bollag Gideon & Hirth Klaus-Peter & Ibrahim Prabha N. & Lin Paul & West Brian
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✓
- June 8, 2033
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Solid forms of a compound modulating kinases
Patent 9,802,932
Issued: October 31, 2017
Inventor(s): Ibrahim Prabha N. & Visor Gary Conard
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:
Patent expiration dates:
- May 5, 2036✓
- May 5, 2036
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 - FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION S
- August 2, 2026 - INDICATED FOR THE 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
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Glossary
Term | Definition |
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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.