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Last Updated: July 13, 2024

Details for New Drug Application (NDA): 216059


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NDA 216059 describes JAYPIRCA, which is a drug marketed by Loxo Oncol and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the JAYPIRCA profile page.

The generic ingredient in JAYPIRCA is pirtobrutinib. One supplier is listed for this compound. Additional details are available on the pirtobrutinib profile page.
Summary for 216059
Tradename:JAYPIRCA
Applicant:Loxo Oncol
Ingredient:pirtobrutinib
Patents:4
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216059
Generic Entry Date for 216059*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL) WHO HAVE RECEIVED AT LEAST TWO PRIOR LINES OF THERAPY, INCLUDING A BTK INHIBITOR AND A BCL-2 INHIBITOR
Dosage:
TABLET;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: 216059
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
JAYPIRCA pirtobrutinib TABLET;ORAL 216059 NDA Eli Lilly and Company 0002-6902 0002-6902-30 30 TABLET, COATED in 1 BOTTLE (0002-6902-30)
JAYPIRCA pirtobrutinib TABLET;ORAL 216059 NDA Eli Lilly and Company 0002-7026 0002-7026-60 60 TABLET, COATED in 1 BOTTLE (0002-7026-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jan 27, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 27, 2028
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 1, 2030
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL) WHO HAVE RECEIVED AT LEAST TWO PRIOR LINES OF THERAPY, INCLUDING A BTK INHIBITOR AND A BCL-2 INHIBITOR
Regulatory Exclusivity Expiration:Jan 27, 2030
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MANTLE CELL LYMPHOMA (MCL) AFTER AT LEAST TWO LINES OF SYSTEMIC THERAPY, INCLUDING A BTK INHIBITOR

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