Application 211371

Type: NDA
Sponsor: SAGE THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZULRESSO	BREXANOLONE	SOLUTION;INTRAVENOUS	100MG/20ML (5MG/ML)	Yes	Yes

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

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
N211371-001	ZULRESSO	BREXANOLONE	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS		RLD	2019-06-17

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
N211371-001	10117951	2029-03-13		Drug product	2019-06-27
N211371-001	7635773	2029-03-13		Drug product	2019-06-27
N211371-001	8410077	2029-03-13		Drug product	2019-06-27
N211371-001	9200088	2029-03-13		Drug product	2019-06-27
N211371-001	9750822	2029-03-13		Drug product	2019-06-27
N211371-001	10322139	2033-01-23		Drug product	2019-06-27
N211371-001	10251894	2033-11-27	U-2552		2019-06-27
N211371-001	10940156	2037-03-08	U-2552		2021-04-07

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N211371-001	ZULRESSO	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-06-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211371-001	ZULRESSO	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-06-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211371-001	ZULRESSO	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2019-06-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211371-001	ZULRESSO	100MG/20ML (5MG/ML)	SOLUTION / INTRAVENOUS	RLD	2019-06-17	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 345 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	N211371-001	10117951	2029-03-13		Drug product	2019-06-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211371-001	7635773	2029-03-13		Drug product	2019-06-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211371-001	8410077	2029-03-13		Drug product	2019-06-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211371-001	9200088	2029-03-13		Drug product	2019-06-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211371-001	9750822	2029-03-13		Drug product	2019-06-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211371-001	10322139	2033-01-23		Drug product	2019-06-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211371-001	10251894	2033-11-27	U-2552		2019-06-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N211371-001	10940156	2037-03-08	U-2552		2021-04-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N211371-001	10117951	2029-03-13		Drug product	2019-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211371-001	7635773	2029-03-13		Drug product	2019-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211371-001	8410077	2029-03-13		Drug product	2019-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211371-001	9200088	2029-03-13		Drug product	2019-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211371-001	9750822	2029-03-13		Drug product	2019-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211371-001	10322139	2033-01-23		Drug product	2019-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211371-001	10251894	2033-11-27	U-2552		2019-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211371-001	10940156	2037-03-08	U-2552		2021-04-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211371-001	10117951	2029-03-13		Drug product	2019-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211371-001	7635773	2029-03-13		Drug product	2019-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211371-001	8410077	2029-03-13		Drug product	2019-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211371-001	9200088	2029-03-13		Drug product	2019-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211371-001	9750822	2029-03-13		Drug product	2019-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211371-001	10322139	2033-01-23		Drug product	2019-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211371-001	10251894	2033-11-27	U-2552		2019-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211371-001	10940156	2037-03-08	U-2552		2021-04-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211371-001	10117951	2029-03-13		Drug product	2019-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211371-001	7635773	2029-03-13		Drug product	2019-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211371-001	8410077	2029-03-13		Drug product	2019-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211371-001	9200088	2029-03-13		Drug product	2019-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211371-001	9750822	2029-03-13		Drug product	2019-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211371-001	10322139	2033-01-23		Drug product	2019-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211371-001	10251894	2033-11-27	U-2552		2019-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211371-001	10940156	2037-03-08	U-2552		2021-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211371-001	10117951	2029-03-13		Drug product	2019-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211371-001	7635773	2029-03-13		Drug product	2019-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211371-001	8410077	2029-03-13		Drug product	2019-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211371-001	9200088	2029-03-13		Drug product	2019-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211371-001	9750822	2029-03-13		Drug product	2019-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211371-001	10322139	2033-01-23		Drug product	2019-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211371-001	10251894	2033-11-27	U-2552		2019-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211371-001	10940156	2037-03-08	U-2552		2021-04-07	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211371-001	NPP	2025-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211371-001	NPP	2025-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211371-001	NPP	2025-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211371-001	NPP	2025-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211371-001	NCE	2024-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211371-001	NPP	2025-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211371-001	NCE	2024-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211371-001	NPP	2025-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211371-001	NCE	2024-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211371-001	NPP	2025-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211371-001	NCE	2024-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211371-001	NPP	2025-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211371-001	NCE	2024-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211371-001	NPP	2025-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211371-001	NCE	2024-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211371-001	NPP	2025-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211371-001	NCE	2024-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211371-001	NPP	2025-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211371-001	NCE	2024-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211371-001	NPP	2025-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211371-001	NCE	2024-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211371-001	NPP	2025-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211371-001	NCE	2024-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211371-001	NCE	2024-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211371-001	NCE	2024-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211371-001	NCE	2024-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211371-001	NCE	2024-06-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211371-001	NCE	2024-06-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211371-001	NCE	2024-06-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211371-001	NCE	2024-06-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211371-001	NCE	2024-06-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211371-001	NCE	2024-06-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211371-001	NCE	2024-06-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211371-001	NCE	2024-06-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211371-001	NCE	2024-06-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211371-001	NCE	2024-06-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211371-001	NPP	2025-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211371-001	NCE	2024-06-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N211371-001	NPP	2025-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211371-001	NCE	2024-06-17	`ea1830bbd6c7…`

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72152-547	Zulresso	brexanolone	Sage Therapeutics, Inc.	NDA	Current
72152-547	Zulresso	brexanolone	Sage Therapeutics, Inc.	NDA	Current
72152-547	Zulresso	brexanolone	Sage Therapeutics, Inc.	NDA	Current
72152-547	Zulresso	brexanolone	Sage Therapeutics, Inc.	NDA	Current
72152-547	Zulresso	brexanolone	Sage Therapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81091	SUPPL	2025-02-06
76529	ORIG	2023-11-08
75833	SUPPL	2023-10-18
73679	SUPPL	2023-03-06
71360	SUPPL	2022-06-21
71359	SUPPL	2022-06-21
71351	SUPPL	2022-06-17
68934	ORIG	2021-10-08
61311	SUPPL	2019-12-17
60408	SUPPL	2019-10-09
60014	SUPPL	2019-09-16
60004	SUPPL	2019-09-16
60003	SUPPL	2019-09-16
58812	SUPPL	2019-05-21
58460	ORIG	2019-04-29
58043	ORIG	2019-03-20
58042	ORIG	2019-03-19