Application 211765

Type: NDA
Sponsor: ALLERGAN

Application Products#

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

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

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
N211765-001	UBRELVY	UBROGEPANT	50MG	TABLET / ORAL		RLD	2019-12-23
N211765-002	UBRELVY	UBROGEPANT	100MG	TABLET / ORAL		RLD, RS	2019-12-23

Orange Book patents#

Current patent rows page 1 of 1 · 28 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211765-001	9499545	2031-11-10	U-2718	Drug substance, Drug product	2020-01-21
N211765-001	9833448	2031-11-10	U-2718		2020-01-21
N211765-001	8754096	2032-07-19	U-2717	Drug substance, Drug product	2020-01-21
N211765-001	8912210	2033-12-23		Drug substance, Drug product	2020-01-21
N211765-001	10117836	2035-01-30		Drug product	2020-01-21
N211765-001	11925709	2035-01-30		Drug product	2024-04-10
N211765-001	12168004	2035-01-30		Drug product	2025-01-15
N211765-001	12220408	2035-01-30		Drug product	2025-03-12
N211765-001	12310953	2035-01-30		Drug product	2025-06-25
N211765-001	12458632	2035-01-30		Drug product	2025-11-04
N211765-001	12458633	2035-01-30		Drug product	2025-11-04
N211765-001	11717515	2041-12-22	U-3677		2023-09-07
N211765-001	11857542	2041-12-22	U-3786		2024-01-31
N211765-001	12194030	2041-12-22	U-4121		2025-02-11
N211765-001	12194030	2041-12-22	U-4122		2025-02-11
N211765-001	12329750	2041-12-22	U-4213		2025-07-16
N211765-002	9499545	2031-11-10	U-2718	Drug substance, Drug product	2020-01-21
N211765-002	9833448	2031-11-10	U-2718		2020-01-21
N211765-002	8754096	2032-07-19	U-2717	Drug substance, Drug product	2020-01-21
N211765-002	8912210	2033-12-23		Drug substance, Drug product	2020-01-21
N211765-002	10117836	2035-01-30		Drug product	2020-01-21
N211765-002	11925709	2035-01-30		Drug product	2024-04-10
N211765-002	12168004	2035-01-30		Drug product	2025-01-15
N211765-002	12220408	2035-01-30		Drug product	2025-03-12
N211765-002	12310953	2035-01-30		Drug product	2025-06-25
N211765-002	12458632	2035-01-30		Drug product	2025-11-04
N211765-002	12458633	2035-01-30		Drug product	2025-11-04
N211765-002	12070450	2041-12-22	U-3992		2024-09-25

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 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N211765-001	UBRELVY	50MG	TABLET / ORAL	RLD	2019-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211765-002	UBRELVY	100MG	TABLET / ORAL	RLD, RS	2019-12-23	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 559 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	N211765-001	9499545	2031-11-10	U-2718	Drug substance, Drug product	2020-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	9833448	2031-11-10	U-2718		2020-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	8754096	2032-07-19	U-2717	Drug substance, Drug product	2020-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	8912210	2033-12-23		Drug substance, Drug product	2020-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	10117836	2035-01-30		Drug product	2020-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	11925709	2035-01-30		Drug product	2024-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	12168004	2035-01-30		Drug product	2025-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	12220408	2035-01-30		Drug product	2025-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	12310953	2035-01-30		Drug product	2025-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	12458632	2035-01-30		Drug product	2025-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	12458633	2035-01-30		Drug product	2025-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	11717515	2041-12-22	U-3677		2023-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	11857542	2041-12-22	U-3786		2024-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	12194030	2041-12-22	U-4121		2025-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	12194030	2041-12-22	U-4122		2025-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-001	12329750	2041-12-22	U-4213		2025-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-002	9499545	2031-11-10	U-2718	Drug substance, Drug product	2020-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-002	9833448	2031-11-10	U-2718		2020-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-002	8754096	2032-07-19	U-2717	Drug substance, Drug product	2020-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-002	8912210	2033-12-23		Drug substance, Drug product	2020-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-002	10117836	2035-01-30		Drug product	2020-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-002	11925709	2035-01-30		Drug product	2024-04-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-002	12168004	2035-01-30		Drug product	2025-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-002	12220408	2035-01-30		Drug product	2025-03-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-002	12310953	2035-01-30		Drug product	2025-06-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-002	12458632	2035-01-30		Drug product	2025-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-002	12458633	2035-01-30		Drug product	2025-11-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211765-002	12070450	2041-12-22	U-3992		2024-09-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211765-001	9499545	2031-11-10	U-2718	Drug substance, Drug product	2020-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211765-001	9833448	2031-11-10	U-2718		2020-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211765-001	8754096	2032-07-19	U-2717	Drug substance, Drug product	2020-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211765-001	8912210	2033-12-23		Drug substance, Drug product	2020-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211765-001	10117836	2035-01-30		Drug product	2020-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211765-001	11925709	2035-01-30		Drug product	2024-04-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211765-001	12168004	2035-01-30		Drug product	2025-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211765-001	12220408	2035-01-30		Drug product	2025-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211765-001	12310953	2035-01-30		Drug product	2025-06-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211765-001	12458632	2035-01-30		Drug product	2025-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211765-001	12458633	2035-01-30		Drug product	2025-11-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211765-001	11717515	2041-12-22	U-3677		2023-09-07	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	N211765-001	NCE	2024-12-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N211765-002	NCE	2024-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211765-001	NCE	2024-12-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211765-002	NCE	2024-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211765-001	NCE	2024-12-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211765-002	NCE	2024-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211765-001	NCE	2024-12-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211765-002	NCE	2024-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211765-001	NCE	2024-12-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211765-002	NCE	2024-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211765-001	NCE	2024-12-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N211765-002	NCE	2024-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211765-001	NCE	2024-12-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N211765-002	NCE	2024-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211765-001	NCE	2024-12-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211765-002	NCE	2024-12-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211765-001	NCE	2024-12-23	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N211765-002	NCE	2024-12-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N211765-001	NCE	2024-12-23	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N211765-002	NCE	2024-12-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211765-001	NCE	2024-12-23	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N211765-002	NCE	2024-12-23	`cb3db0bc1861…`

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-6498	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6498	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6498	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6498	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6498	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6498	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6498	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6498	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6501	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6501	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6501	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6501	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6501	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6501	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6501	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current
0023-6501	UBRELVY	ubrogepant	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82554	SUPPL	2025-06-13
82477	SUPPL	2025-06-06
81712	SUPPL	2025-03-25
81699	SUPPL	2025-03-24
73578	SUPPL	2023-02-21
73555	SUPPL	2023-02-17
66481	SUPPL	2021-03-04
61608	ORIG	2020-01-22
61456	ORIG	2019-12-26
61434	ORIG	2019-12-23