Application 208383

Type: NDA
Sponsor: PORTOLA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BEVYXXA	BETRIXABAN	CAPSULE;ORAL	40MG	Yes	No
002	BEVYXXA	BETRIXABAN	CAPSULE;ORAL	80MG	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
N208383-001	BEVYXXA	BETRIXABAN	40MG	CAPSULE / ORAL		RLD	2017-06-23
N208383-002	BEVYXXA	BETRIXABAN	80MG	CAPSULE / ORAL		RLD	2017-06-23

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208383-001	9555023	2026-11-07	U-1502		2017-07-21
N208383-001	7598276	2026-11-08		Drug substance	2017-07-21
N208383-001	8557852	2028-09-08	U-1167		2017-07-21
N208383-001	8557852	2028-09-08	U-2030		2017-07-21
N208383-001	8987463	2030-12-28		Drug product	2017-07-21
N208383-001	8404724	2031-03-29	U-2034	Drug product	2017-07-21
N208383-002	9555023	2026-11-07	U-1502		2017-07-21
N208383-002	7598276	2026-11-08		Drug substance	2017-07-21
N208383-002	8557852	2028-09-08	U-1167		2017-07-21
N208383-002	8557852	2028-09-08	U-2030		2017-07-21
N208383-002	8987463	2030-12-28		Drug product	2017-07-21
N208383-002	8404724	2031-03-29	U-2034	Drug product	2017-07-21

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 3 · 86 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	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD	2017-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208383-001	BEVYXXA	40MG	CAPSULE / ORAL	RLD	2017-06-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208383-002	BEVYXXA	80MG	CAPSULE / ORAL	RLD, RS	2017-06-23	`74a2ff9319b5…`

Observed Orange Book patent history#

Patent history page 1 of 17 · 660 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	N208383-001	9555023	2026-11-07	U-1502		2017-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208383-001	7598276	2026-11-08		Drug substance	2017-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208383-001	8557852	2028-09-08	U-1167		2017-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208383-001	8557852	2028-09-08	U-2030		2017-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208383-001	8987463	2030-12-28		Drug product	2017-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208383-001	8404724	2031-03-29	U-2034	Drug product	2017-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208383-002	9555023	2026-11-07	U-1502		2017-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208383-002	7598276	2026-11-08		Drug substance	2017-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208383-002	8557852	2028-09-08	U-1167		2017-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208383-002	8557852	2028-09-08	U-2030		2017-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208383-002	8987463	2030-12-28		Drug product	2017-07-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N208383-002	8404724	2031-03-29	U-2034	Drug product	2017-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N208383-001	9555023	2026-11-07	U-1502		2017-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208383-001	7598276	2026-11-08		Drug substance	2017-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208383-001	8557852	2028-09-08	U-1167		2017-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208383-001	8557852	2028-09-08	U-2030		2017-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208383-001	8987463	2030-12-28		Drug product	2017-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208383-001	8404724	2031-03-29	U-2034	Drug product	2017-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208383-002	9555023	2026-11-07	U-1502		2017-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208383-002	7598276	2026-11-08		Drug substance	2017-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208383-002	8557852	2028-09-08	U-1167		2017-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208383-002	8557852	2028-09-08	U-2030		2017-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208383-002	8987463	2030-12-28		Drug product	2017-07-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N208383-002	8404724	2031-03-29	U-2034	Drug product	2017-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208383-001	9555023	2026-11-07	U-1502		2017-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208383-001	7598276	2026-11-08		Drug substance	2017-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208383-001	8557852	2028-09-08	U-1167		2017-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208383-001	8557852	2028-09-08	U-2030		2017-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208383-001	8987463	2030-12-28		Drug product	2017-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208383-001	8404724	2031-03-29	U-2034	Drug product	2017-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208383-002	9555023	2026-11-07	U-1502		2017-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208383-002	7598276	2026-11-08		Drug substance	2017-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208383-002	8557852	2028-09-08	U-1167		2017-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208383-002	8557852	2028-09-08	U-2030		2017-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208383-002	8987463	2030-12-28		Drug product	2017-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208383-002	8404724	2031-03-29	U-2034	Drug product	2017-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208383-001	9555023	2026-11-07	U-1502		2017-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208383-001	7598276	2026-11-08		Drug substance	2017-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208383-001	8557852	2028-09-08	U-1167		2017-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208383-001	8557852	2028-09-08	U-2030		2017-07-21	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208383-001	NCE	2022-06-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208383-002	NCE	2022-06-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208383-001	NCE	2022-06-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208383-002	NCE	2022-06-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208383-001	NCE	2022-06-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208383-002	NCE	2022-06-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208383-001	NCE	2022-06-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208383-002	NCE	2022-06-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208383-001	NCE	2022-06-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208383-002	NCE	2022-06-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208383-001	NCE	2022-06-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208383-002	NCE	2022-06-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208383-001	NCE	2022-06-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208383-002	NCE	2022-06-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208383-001	NCE	2022-06-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208383-002	NCE	2022-06-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208383-001	NCE	2022-06-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208383-002	NCE	2022-06-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208383-001	NCE	2022-06-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208383-002	NCE	2022-06-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208383-001	NCE	2022-06-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208383-002	NCE	2022-06-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208383-001	NCE	2022-06-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208383-002	NCE	2022-06-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208383-001	NCE	2022-06-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208383-002	NCE	2022-06-23	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N208383-001	NCE	2022-06-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N208383-002	NCE	2022-06-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208383-001	NCE	2022-06-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208383-002	NCE	2022-06-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208383-001	NCE	2022-06-23	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N208383-002	NCE	2022-06-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208383-001	NCE	2022-06-23	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N208383-002	NCE	2022-06-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208383-001	NCE	2022-06-23	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208383-002	NCE	2022-06-23	`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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69853-0201	BEVYXXA	betrixaban	Portola Pharmaceuticals, Inc.	NDA	Current
69853-0201	BEVYXXA	betrixaban	Portola Pharmaceuticals,	NDA	Current
69853-0201	BEVYXXA	betrixaban	Portola Pharmaceuticals, Inc.	NDA	Current
69853-0202	BEVYXXA	betrixaban	Portola Pharmaceuticals, Inc.	NDA	Current
69853-0202	BEVYXXA	betrixaban	Portola Pharmaceuticals,	NDA	Current
69853-0202	BEVYXXA	betrixaban	Portola Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
64466	SUPPL	2020-09-01
64412	SUPPL	2020-08-25
59386	SUPPL	2019-07-19
59380	SUPPL	2019-07-19
49056	ORIG	2017-07-25
49000	SUPPL	2017-07-17
48997	SUPPL	2017-07-17
48813	ORIG	2017-06-23
48812	ORIG	2017-06-23
48811	ORIG	2017-06-23