Litfulo

Product NDC: 63539-334
11-digit product format: 635390334
Labeler code: 63539
Product ID: 63539-334_6845750b-223c-45ae-bdf3-848d9cef0098
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ritlecitinib
Dosage form: CAPSULE
Route: ORAL
Labeler: U.S. Pharmaceuticals
Application: NDA215830
Marketing category: NDA
Marketing start: 2023-07-06
Substance: RITLECITINIB TOSYLATE
Active strength: 50 mg/1
Pharmacologic classes: Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], Janus Kinase 3 Inhibitors [MoA], Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215830-001	LITFULO	RITLECITINIB TOSYLATE	EQ 50MG BASE	CAPSULE / ORAL		RLD, RS	2023-06-23

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215830-001	12077533	2034-12-03	U-3994		2024-10-02
N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21
N215830-001	12116368	2041-10-17		Drug substance	2024-10-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215830-001	NCE	2028-06-23

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215830-001	LITFULO	EQ 50MG BASE	CAPSULE / ORAL	RLD, RS	2023-06-23	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 45 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N215830-001	12077533	2034-12-03	U-3994		2024-10-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215830-001	12116368	2041-10-17		Drug substance	2024-10-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215830-001	12077533	2034-12-03	U-3994		2024-10-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215830-001	12116368	2041-10-17		Drug substance	2024-10-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215830-001	12077533	2034-12-03	U-3994		2024-10-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215830-001	12116368	2041-10-17		Drug substance	2024-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215830-001	12077533	2034-12-03	U-3994		2024-10-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215830-001	12116368	2041-10-17		Drug substance	2024-10-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215830-001	12077533	2034-12-03	U-3994		2024-10-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215830-001	12116368	2041-10-17		Drug substance	2024-10-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215830-001	12077533	2034-12-03	U-3994		2024-10-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215830-001	12116368	2041-10-17		Drug substance	2024-10-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215830-001	12077533	2034-12-03	U-3994		2024-10-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215830-001	12116368	2041-10-17		Drug substance	2024-10-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215830-001	12077533	2034-12-03	U-3994		2024-10-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215830-001	12116368	2041-10-17		Drug substance	2024-10-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215830-001	12077533	2034-12-03	U-3994		2024-10-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215830-001	12116368	2041-10-17		Drug substance	2024-10-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215830-001	12077533	2034-12-03	U-3994		2024-10-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215830-001	12116368	2041-10-17		Drug substance	2024-10-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215830-001	12077533	2034-12-03	U-3994		2024-10-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215830-001	9617258	2034-12-03		Drug substance, Drug product	2023-07-21	`ea1830bbd6c7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N215830-001	NCE	2028-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215830-001	NCE	2028-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215830-001	NCE	2028-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215830-001	NCE	2028-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215830-001	NCE	2028-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215830-001	NCE	2028-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215830-001	NCE	2028-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215830-001	NCE	2028-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215830-001	NCE	2028-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215830-001	NCE	2028-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215830-001	NCE	2028-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215830-001	NCE	2028-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215830-001	NCE	2028-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215830-001	NCE	2028-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215830-001	NCE	2028-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215830-001	NCE	2028-06-23	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215830-001	NCE	2028-06-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215830-001	NCE	2028-06-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215830-001	NCE	2028-06-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215830-001	NCE	2028-06-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215830-001	NCE	2028-06-23	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215830-001	NCE	2028-06-23	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Litfulo
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RITLECITINIB TOSYLATE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EAG4T1459K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2641601	Internal RxNorm lookup
2641607	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1882f799-61b0-4813-965a-4910c4ae419c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4f034d61-108f-45bd-ade2-f2d536b61b7c	Product name	1	20231023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63539-334-28	Litfulo	28 in 1 BOTTLE	CAPSULE	28		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63539-334	LITFULO (RITLECITINIB) CAPSULE [U.S. PHARMACEUTICALS]	2	Current NDC, 1 package rows	20250322_1882f799-61b0-4813-965a-4910c4ae419c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Litfulo	RITLECITINIB	U.S. Pharmaceuticals	1882f799-61b0-4813-965a-4910c4ae419c	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215830 application number: NDA215830 ndc (product): 63539-334
Litfulo	RITLECITINIB	Pfizer Laboratories Div Pfizer Inc	6b2f9446-fb23-4741-b73a-5a2f993733c3	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215830 application number: NDA215830

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2641607	Litfulo 50 MG Oral Capsule	PSN	1882f799-61b0-4813-965a-4910c4ae419c	2
2641601	ritlecitinib 50 MG Oral Capsule	PSN	1882f799-61b0-4813-965a-4910c4ae419c	2
2641607	ritlecitinib 50 MG Oral Capsule [Litfulo]	SBD	1882f799-61b0-4813-965a-4910c4ae419c	2
2641601	ritlecitinib 50 MG Oral Capsule	SCD	1882f799-61b0-4813-965a-4910c4ae419c	2
2641607	Litfulo 50 MG (equivalent to ritlecitinib tosylate 80.13 MG) Oral Capsule	SY	1882f799-61b0-4813-965a-4910c4ae419c	2
2641601	ritlecitinib 50 MG (equivalent to ritlecitinib tosylate 80.13 MG) Oral Capsule	SY	1882f799-61b0-4813-965a-4910c4ae419c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
63539-334-28	63539033428	28 CAPSULE in 1 BOTTLE (63539-334-28)	28 capsule	2023-07-06	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Litfulo	U.S. Pharmaceuticals \| Pfizer Inc \| Pfizer Ireland Pharmaceuticals Unlimited Company \| Pfizer Manufacturing Deutschland GmbH	2026-06-17	HUMAN PRESCRIPTION DRUG LABEL	3