Application 216059

Type: NDA
Sponsor: LOXO ONCOLOGY INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JAYPIRCA	PIRTOBRUTINIB	TABLET;ORAL	50MG	No	No
002	JAYPIRCA	PIRTOBRUTINIB	TABLET;ORAL	100MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N216059-001	JAYPIRCA	PIRTOBRUTINIB	50MG	TABLET / ORAL		RLD	2023-01-27
N216059-002	JAYPIRCA	PIRTOBRUTINIB	100MG	TABLET / ORAL		RLD, RS	2023-01-27

Orange Book patents#

Current patent rows page 1 of 1 · 22 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216059-001	10342780	2036-12-16		Drug substance, Drug product	2023-02-10
N216059-001	10464905	2036-12-16	U-3518		2023-02-10
N216059-001	10464905	2036-12-16	U-4362		2023-02-10
N216059-001	10695323	2036-12-16	U-3518	Drug substance, Drug product	2023-02-10
N216059-001	10695323	2036-12-16	U-4362	Drug substance, Drug product	2023-02-10
N216059-001	10918622	2036-12-16	U-3518		2023-02-10
N216059-001	10918622	2036-12-16	U-4362		2023-02-10
N216059-001	12220401	2036-12-16	U-3518	Drug substance, Drug product	2025-03-05
N216059-001	12220401	2036-12-16	U-4362	Drug substance, Drug product	2025-03-05
N216059-001	12268666	2039-07-29		Drug product	2025-05-06
N216059-001	12109193	2041-09-14		Drug product	2024-10-31
N216059-002	10342780	2036-12-16		Drug substance, Drug product	2023-02-10
N216059-002	10464905	2036-12-16	U-3518		2023-02-10
N216059-002	10464905	2036-12-16	U-4362		2023-02-10
N216059-002	10695323	2036-12-16	U-3518	Drug substance, Drug product	2023-02-10
N216059-002	10695323	2036-12-16	U-4362	Drug substance, Drug product	2023-02-10
N216059-002	10918622	2036-12-16	U-3518		2023-02-10
N216059-002	10918622	2036-12-16	U-4362		2023-02-10
N216059-002	12220401	2036-12-16	U-3518	Drug substance, Drug product	2025-03-05
N216059-002	12220401	2036-12-16	U-4362	Drug substance, Drug product	2025-03-05
N216059-002	12268666	2039-07-29		Drug product	2025-05-06
N216059-002	12109193	2041-09-14		Drug product	2024-10-31

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 10 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216059-001	NCE	2028-01-27
N216059-001	I-981	2028-12-02
N216059-001	ODE-424	2030-01-27
N216059-001	ODE-451	2030-12-01
N216059-001	ODE-518	2032-12-03
N216059-002	NCE	2028-01-27
N216059-002	I-981	2028-12-02
N216059-002	ODE-424	2030-01-27
N216059-002	ODE-451	2030-12-01
N216059-002	ODE-518	2032-12-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216059-001	JAYPIRCA	50MG	TABLET / ORAL	RLD	2023-01-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N216059-002	JAYPIRCA	100MG	TABLET / ORAL	RLD, RS	2023-01-27	`ea1830bbd6c7…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 398 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N216059-001	10342780	2036-12-16		Drug substance, Drug product	2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	10464905	2036-12-16	U-3518		2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	10464905	2036-12-16	U-4362		2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	10695323	2036-12-16	U-3518	Drug substance, Drug product	2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	10695323	2036-12-16	U-4362	Drug substance, Drug product	2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	10918622	2036-12-16	U-3518		2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	10918622	2036-12-16	U-4362		2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	12220401	2036-12-16	U-3518	Drug substance, Drug product	2025-03-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	12220401	2036-12-16	U-4362	Drug substance, Drug product	2025-03-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	12268666	2039-07-29		Drug product	2025-05-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	12109193	2041-09-14		Drug product	2024-10-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	10342780	2036-12-16		Drug substance, Drug product	2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	10464905	2036-12-16	U-3518		2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	10464905	2036-12-16	U-4362		2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	10695323	2036-12-16	U-3518	Drug substance, Drug product	2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	10695323	2036-12-16	U-4362	Drug substance, Drug product	2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	10918622	2036-12-16	U-3518		2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	10918622	2036-12-16	U-4362		2023-02-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	12220401	2036-12-16	U-3518	Drug substance, Drug product	2025-03-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	12220401	2036-12-16	U-4362	Drug substance, Drug product	2025-03-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	12268666	2039-07-29		Drug product	2025-05-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	12109193	2041-09-14		Drug product	2024-10-31	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216059-001	10342780	2036-12-16		Drug substance, Drug product	2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	10464905	2036-12-16	U-3518		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	10464905	2036-12-16	U-4362		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	10695323	2036-12-16	U-3518	Drug substance, Drug product	2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	10695323	2036-12-16	U-4362	Drug substance, Drug product	2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	10918622	2036-12-16	U-3518		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	10918622	2036-12-16	U-4362		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	12220401	2036-12-16	U-3518	Drug substance, Drug product	2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	12220401	2036-12-16	U-4362	Drug substance, Drug product	2025-03-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	12268666	2039-07-29		Drug product	2025-05-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	12109193	2041-09-14		Drug product	2024-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10342780	2036-12-16		Drug substance, Drug product	2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10464905	2036-12-16	U-3518		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10464905	2036-12-16	U-4362		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10695323	2036-12-16	U-3518	Drug substance, Drug product	2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10695323	2036-12-16	U-4362	Drug substance, Drug product	2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10918622	2036-12-16	U-3518		2023-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	10918622	2036-12-16	U-4362		2023-02-10	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N216059-001	NCE	2028-01-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	I-981	2028-12-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	ODE-424	2030-01-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	ODE-451	2030-12-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-001	ODE-518	2032-12-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	NCE	2028-01-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	I-981	2028-12-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	ODE-424	2030-01-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	ODE-451	2030-12-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N216059-002	ODE-518	2032-12-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N216059-001	NCE	2028-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	I-981	2028-12-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	ODE-424	2030-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	ODE-451	2030-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-001	ODE-518	2032-12-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	NCE	2028-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	I-981	2028-12-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	ODE-424	2030-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	ODE-451	2030-12-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N216059-002	ODE-518	2032-12-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N216059-001	NCE	2028-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	I-981	2028-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	ODE-424	2030-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	ODE-451	2030-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-001	ODE-518	2032-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	NCE	2028-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	I-981	2028-12-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	ODE-424	2030-01-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	ODE-451	2030-12-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216059-002	ODE-518	2032-12-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216059-001	NCE	2028-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-001	I-981	2028-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-001	ODE-424	2030-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-001	ODE-451	2030-12-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-002	NCE	2028-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-002	I-981	2028-12-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-002	ODE-424	2030-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216059-002	ODE-451	2030-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216059-001	NCE	2028-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216059-001	ODE-424	2030-01-27	`31067a03dcf5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84368	SUPPL	2025-12-09
84352	SUPPL	2025-12-08
78652	SUPPL	2024-06-05
78631	SUPPL	2024-06-05
76726	SUPPL	2023-12-05
76716	SUPPL	2023-12-01
73601	ORIG	2023-02-24
73489	ORIG	2023-02-14
73350	ORIG	2023-01-31