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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 211810


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NDA 211810 describes TURALIO, which is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the TURALIO profile page.

The generic ingredient in TURALIO is pexidartinib hydrochloride. One supplier is listed for this compound. Additional details are available on the pexidartinib hydrochloride profile page.
Summary for 211810
Tradename:TURALIO
Applicant:Daiichi Sankyo Inc
Ingredient:pexidartinib hydrochloride
Patents:12
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211810
Generic Entry Date for 211810*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 211810
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810 NDA Daiichi Sankyo, Inc. 65597-407 65597-407-20 1 BOTTLE in 1 CARTON (65597-407-20) / 120 CAPSULE in 1 BOTTLE
TURALIO pexidartinib hydrochloride CAPSULE;ORAL 211810 NDA Daiichi Sankyo, Inc. 65597-407 65597-407-28 1 BOTTLE in 1 CARTON (65597-407-28) / 28 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Aug 2, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 2, 2026
Regulatory Exclusivity Use: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
Regulatory Exclusivity Expiration:Aug 2, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Try a TrialPatent Expiration:May 5, 2036Product Flag?Substance Flag?Delist Request?
Patented 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

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