Prescription medicine
Pirtobrutinib Brand names: Jaypirca
Pirtobrutinib (Jaypirca) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the pirtobrutinib FDA label on DailyMed (effective March 6, 2026, Eli Lilly and Company); the NDA 216059 record on Drugs@FDA; every pirtobrutinib label on DailyMed.
Highlights of the record
FDA label of March 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageJAYPIRCA ® is a kinase inhibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
Forms and strengths
- 50 mg
- 100 mg
Coated tablet.
On the market
- Earliest approval on file
- January 27, 2023 Jaypirca, Loxo Oncol; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- September 14, 2041 Jaypirca tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 823 through July 30, 2026
What is pirtobrutinib used for?
From the label: indications and usageJAYPIRCA ® is a kinase inhibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. ( 1.1 ). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. […]
Conditions named in the indications of pirtobrutinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (JAYPIRCA), NDA216059 (Loxo Oncol), as published by Eli Lilly and Company, effective March 6, 2026 (SPL set bd551845-0878-49a4-860f-839b83f6b801), via openFDA; the full label on DailyMed
Is there a generic for pirtobrutinib (Jaypirca)?
No generic pirtobrutinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Jaypirca tablets: the compound patent runs to December 16, 2036, and the last listed entry to September 14, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for pirtobrutinib?
The FDA Adverse Event Reporting System holds 823 reports that list pirtobrutinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 209 are coded as a death and 252 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as pirtobrutinib?
37 other medicines are given the same way (oral) and in the same FDA class as pirtobrutinib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Bosutinib | Leukemia, lymphoma and myeloma | 3 labelers | n/a | No current entry |
| Ibrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Ponatinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Acalabrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Quizartinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as pirtobrutinib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to pirtobrutinib
- 37 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Pirtobrutinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other