Application 215596

Type: NDA
Sponsor: TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LIVTENCITY	MARIBAVIR	TABLET;ORAL	400MG	No	No

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
N215596-001	LIVTENCITY	MARIBAVIR	200MG	TABLET / ORAL		RLD, RS	2021-11-23

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215596-001	12447169	2031-10-27	U-4329		2025-11-18
N215596-001	12661368	2031-10-27	U-4572		2026-07-14
N215596-001	11684632	2032-01-04	U-3650		2023-07-21
N215596-001	12213989	2042-11-18	U-4137		2025-02-27
N215596-001	12433907	2042-11-18	U-4289		2025-10-28
N215596-001	12447170	2042-11-18	U-4328		2025-11-18
N215596-001	12295940	2043-10-11		Drug substance, Drug product	2025-05-29
N215596-001	12527771	2043-10-11		Drug substance, Drug product	2026-02-12

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215596-001	NCE	2026-11-23
N215596-001	ODE-388	2028-11-23

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	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215596-001	LIVTENCITY	200MG	TABLET / ORAL	RLD, RS	2021-11-23	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 55 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	N215596-001	12447169	2031-10-27	U-4329		2025-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215596-001	12661368	2031-10-27	U-4572		2026-07-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215596-001	11684632	2032-01-04	U-3650		2023-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215596-001	12213989	2042-11-18	U-4137		2025-02-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215596-001	12433907	2042-11-18	U-4289		2025-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215596-001	12447170	2042-11-18	U-4328		2025-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215596-001	12295940	2043-10-11		Drug substance, Drug product	2025-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215596-001	12527771	2043-10-11		Drug substance, Drug product	2026-02-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215596-001	12447169	2031-10-27	U-4329		2025-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215596-001	12661368	2031-10-27	U-4572		2026-07-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215596-001	11684632	2032-01-04	U-3650		2023-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215596-001	12213989	2042-11-18	U-4137		2025-02-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215596-001	12433907	2042-11-18	U-4289		2025-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215596-001	12447170	2042-11-18	U-4328		2025-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215596-001	12295940	2043-10-11		Drug substance, Drug product	2025-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215596-001	12527771	2043-10-11		Drug substance, Drug product	2026-02-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215596-001	12447169	2031-10-27	U-4329		2025-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215596-001	11684632	2032-01-04	U-3650		2023-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215596-001	12213989	2042-11-18	U-4137		2025-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215596-001	12433907	2042-11-18	U-4289		2025-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215596-001	12447170	2042-11-18	U-4328		2025-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215596-001	12295940	2043-10-11		Drug substance, Drug product	2025-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215596-001	12447169	2031-10-27	U-4329		2025-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215596-001	11684632	2032-01-04	U-3650		2023-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215596-001	12213989	2042-11-18	U-4137		2025-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215596-001	12433907	2042-11-18	U-4289		2025-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215596-001	12447170	2042-11-18	U-4328		2025-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215596-001	12295940	2043-10-11		Drug substance, Drug product	2025-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215596-001	11684632	2032-01-04	U-3650		2023-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215596-001	12213989	2042-11-18	U-4137		2025-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215596-001	12295940	2043-10-11		Drug substance, Drug product	2025-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215596-001	11684632	2032-01-04	U-3650		2023-07-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215596-001	12213989	2042-11-18	U-4137		2025-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215596-001	11684632	2032-01-04	U-3650		2023-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215596-001	11684632	2032-01-04	U-3650		2023-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215596-001	11684632	2032-01-04	U-3650		2023-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215596-001	11684632	2032-01-04	U-3650		2023-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215596-001	11684632	2032-01-04	U-3650		2023-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215596-001	11684632	2032-01-04	U-3650		2023-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215596-001	11684632	2032-01-04	U-3650		2023-07-21	`79d66fd596c7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 59 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N215596-001	NCE	2026-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215596-001	ODE-388	2028-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215596-001	NCE	2026-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215596-001	ODE-388	2028-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215596-001	NCE	2026-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215596-001	ODE-388	2028-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215596-001	NCE	2026-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215596-001	ODE-388	2028-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215596-001	NCE	2026-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215596-001	ODE-388	2028-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215596-001	NCE	2026-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215596-001	ODE-388	2028-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215596-001	NCE	2026-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215596-001	ODE-388	2028-11-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215596-001	NCE	2026-11-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215596-001	ODE-388	2028-11-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215596-001	NCE	2026-11-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215596-001	ODE-388	2028-11-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215596-001	NCE	2026-11-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215596-001	ODE-388	2028-11-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215596-001	NCE	2026-11-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215596-001	ODE-388	2028-11-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215596-001	NCE	2026-11-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215596-001	ODE-388	2028-11-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215596-001	NCE	2026-11-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215596-001	ODE-388	2028-11-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215596-001	NCE	2026-11-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215596-001	ODE-388	2028-11-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215596-001	NCE	2026-11-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215596-001	ODE-388	2028-11-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215596-001	NCE	2026-11-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215596-001	ODE-388	2028-11-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215596-001	NCE	2026-11-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N215596-001	NCE	2026-11-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N215596-001	NCE	2026-11-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N215596-001	NCE	2026-11-23	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215596-001	NCE	2026-11-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215596-001	ODE-388	2028-11-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215596-001	NCE	2026-11-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215596-001	ODE-388	2028-11-23	`1c564ffb4f44…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Livtencity	MARIBAVIR	Takeda Pharmaceuticals America, Inc.	c94fc2c5-e840-4f18-b7d8-d5eacb26d3a0	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215596 application number: NDA215596 ndc (product): 64764-800

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64764-800	Livtencity	MARIBAVIR	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-800	Livtencity	MARIBAVIR	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-800	Livtencity	MARIBAVIR	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-800	Livtencity	MARIBAVIR	Takeda Pharmaceuticals America, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85894	SUPPL	2026-05-13
84493	SUPPL	2025-12-22
77959	SUPPL	2024-03-25
77944	SUPPL	2024-03-25
74099	SUPPL	2023-04-27
74091	SUPPL	2023-04-27
72060	SUPPL	2022-09-10
72053	SUPPL	2022-09-09
69907	SUPPL	2022-01-19
69744	ORIG	2021-12-22
69417	ORIG	2021-11-24
69410	ORIG	2021-11-24