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 seven patents protecting this drug. Additional details are available on the JAYPIRCA profile page.
The generic ingredient in JAYPIRCA is pirtobrutinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pirtobrutinib profile page.
The generic ingredient in JAYPIRCA is pirtobrutinib. There is one drug master file entry for this compound. 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: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216059
Generic Entry Date for 216059*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 216059
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: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Jan 27, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 2, 2028 | ||||||||
| Regulatory Exclusivity Use: | EXPANSION TO THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LYMPHOMA (CLL/SLL) INDICATION | ||||||||
| 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 | ||||||||
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