Application 214517

Type: NDA
Sponsor: VANDA PHARMACEUTICALS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HETLIOZ	TASIMELTEON	CAPSULE;ORAL	20MG	Yes	No
002	HETLIOZ LQ	TASIMELTEON	SUSPENSION;ORAL	4MG/ML	Yes	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
N214517-001	HETLIOZ LQ	TASIMELTEON	4MG/ML	SUSPENSION / ORAL		RLD, RS	2020-12-01

Orange Book patents#

Current patent rows page 1 of 1 · 27 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214517-001	10149829	2033-01-25	U-3006		2020-12-21
N214517-001	10610510	2033-01-25	U-3009		2020-12-21
N214517-001	10980770	2033-01-25	U-3106		2021-04-15
N214517-001	11285129	2033-01-25	U-3342		2022-04-15
N214517-001	11633377	2033-01-25	U-3003		2023-04-27
N214517-001	11826339	2033-01-25	U-3342		2024-04-04
N214517-001	11833130	2033-01-25	U-3003		2024-01-03
N214517-001	11850229	2033-01-25	U-3342		2024-01-03
N214517-001	11918557	2033-01-25	U-3003		2024-04-04
N214517-001	12201604	2033-01-25	U-3003		2025-02-18
N214517-001	9539234	2033-01-25	U-3004		2020-12-21
N214517-001	11918556	2033-04-07	U-3342		2024-04-04
N214517-001	9730910	2034-05-17	U-3005		2020-12-21
N214517-001	10610511	2034-10-10	U-3007		2020-12-21
N214517-001	11141400	2034-10-10	U-3007		2021-10-25
N214517-001	11786502	2034-10-10	U-3007		2023-11-13
N214517-001	10071977	2035-02-12		Drug substance, Drug product	2020-12-21
N214517-001	10829465	2035-02-12		Drug substance, Drug product	2020-12-21
N214517-001	11566011	2035-02-12		Drug substance, Drug product	2023-02-13
N214517-001	11760740	2035-02-12		Drug substance, Drug product	2023-10-13
N214517-001	12049457	2035-02-12		Drug substance, Drug product	2024-08-02
N214517-001	10376487	2035-07-27	U-3007		2020-12-20
N214517-001	10179119	2035-08-29	U-3003		2020-12-21
N214517-001	11266622	2035-08-29	U-3003		2022-06-14
N214517-001	11202770	2040-12-11		Drug product	2021-12-22
N214517-001	12447141	2040-12-11	U-3003		2025-11-07
N214517-001	11759446	2041-02-21	U-3003		2023-10-13

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214517-001	ODE-329	2027-12-01

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	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214517-001	HETLIOZ LQ	4MG/ML	SUSPENSION / ORAL	RLD, RS	2020-12-01	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 19 · 736 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	N214517-001	10149829	2033-01-25	U-3006		2020-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	10610510	2033-01-25	U-3009		2020-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	10980770	2033-01-25	U-3106		2021-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11285129	2033-01-25	U-3342		2022-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11633377	2033-01-25	U-3003		2023-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11826339	2033-01-25	U-3342		2024-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11833130	2033-01-25	U-3003		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11850229	2033-01-25	U-3342		2024-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11918557	2033-01-25	U-3003		2024-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	12201604	2033-01-25	U-3003		2025-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	9539234	2033-01-25	U-3004		2020-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11918556	2033-04-07	U-3342		2024-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	9730910	2034-05-17	U-3005		2020-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	10610511	2034-10-10	U-3007		2020-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11141400	2034-10-10	U-3007		2021-10-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11786502	2034-10-10	U-3007		2023-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	10071977	2035-02-12		Drug substance, Drug product	2020-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	10829465	2035-02-12		Drug substance, Drug product	2020-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11566011	2035-02-12		Drug substance, Drug product	2023-02-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11760740	2035-02-12		Drug substance, Drug product	2023-10-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	12049457	2035-02-12		Drug substance, Drug product	2024-08-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	10376487	2035-07-27	U-3007		2020-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	10179119	2035-08-29	U-3003		2020-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11266622	2035-08-29	U-3003		2022-06-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11202770	2040-12-11		Drug product	2021-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	12447141	2040-12-11	U-3003		2025-11-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214517-001	11759446	2041-02-21	U-3003		2023-10-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214517-001	10149829	2033-01-25	U-3006		2020-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214517-001	10610510	2033-01-25	U-3009		2020-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214517-001	10980770	2033-01-25	U-3106		2021-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214517-001	11285129	2033-01-25	U-3342		2022-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214517-001	11633377	2033-01-25	U-3003		2023-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214517-001	11826339	2033-01-25	U-3342		2024-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214517-001	11833130	2033-01-25	U-3003		2024-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214517-001	11850229	2033-01-25	U-3342		2024-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214517-001	11918557	2033-01-25	U-3003		2024-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214517-001	12201604	2033-01-25	U-3003		2025-02-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214517-001	9539234	2033-01-25	U-3004		2020-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214517-001	11918556	2033-04-07	U-3342		2024-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214517-001	9730910	2034-05-17	U-3005		2020-12-21	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214517-001	ODE-329	2027-12-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214517-001	NP	2023-12-01	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N214517-001	ODE-329	2027-12-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214517-001	NP	2023-12-01	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N214517-001	ODE-329	2027-12-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214517-001	NP	2023-12-01	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214517-001	ODE-329	2027-12-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214517-001	NP	2023-12-01	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N214517-001	ODE-329	2027-12-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214517-001	NP	2023-12-01	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N214517-001	ODE-329	2027-12-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214517-001	NP	2023-12-01	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214517-001	ODE-329	2027-12-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214517-001	ODE-329	2027-12-01	`a50c72e98297…`

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
Hetlioz	TASIMELTEON	Vanda Pharmaceuticals Inc.	ca4a9b63-708e-49e9-8f9b-010625443b90	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214517 application number: NDA214517 ndc (product): 43068-304

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43068-304	Hetlioz	tasimelteon	Vanda Pharmaceuticals Inc.	NDA	Current
43068-304	Hetlioz	tasimelteon	Vanda Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68121	ORIG	2021-07-19
65484	ORIG	2020-12-02
65481	ORIG	2020-12-02