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.
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.
Pharmacology for NDA: 211810
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: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Aug 2, 2019 | TE: | 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: | 10,189,833 | Patent Expiration: | May 5, 2036 | Product 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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