Application 207999

Type: NDA
Sponsor: INTERCEPT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OCALIVA	OBETICHOLIC ACID	TABLET;ORAL	5MG	Yes	No
002	OCALIVA	OBETICHOLIC ACID	TABLET;ORAL	10MG	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
N207999-001	OCALIVA	OBETICHOLIC ACID	5MG	TABLET / ORAL		RLD	2016-05-27
N207999-002	OCALIVA	OBETICHOLIC ACID	10MG	TABLET / ORAL		RLD	2016-05-27

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207999-001	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28
N207999-001	10174073	2033-06-17		Drug substance	2019-01-15
N207999-001	9238673	2033-06-17		Drug product	2016-06-22
N207999-001	10047117	2033-09-06	U-1854		2018-11-14
N207999-001	10052337	2036-04-26		Drug product	2018-11-08
N207999-001	10751349	2036-04-26		Drug product	2020-08-28
N207999-001	10758549	2036-04-26	U-2945		2020-09-10
N207999-002	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28
N207999-002	10174073	2033-06-17		Drug substance	2019-01-15
N207999-002	9238673	2033-06-17		Drug product	2016-06-22
N207999-002	10047117	2033-09-06	U-1854		2018-11-14
N207999-002	10052337	2036-04-26		Drug product	2018-11-08
N207999-002	10751349	2036-04-26		Drug product	2020-08-28
N207999-002	10758549	2036-04-26	U-2945		2020-09-10

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	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD	2016-05-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD	2016-05-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD	2016-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD	2016-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N207999-001	OCALIVA	5MG	TABLET / ORAL	RLD	2016-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207999-002	OCALIVA	10MG	TABLET / ORAL	RLD, RS	2016-05-27	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207999-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207999-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207999-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207999-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207999-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207999-002	AB	1	`3f0d92c62455…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 684 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	N207999-001	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-001	10174073	2033-06-17		Drug substance	2019-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-001	9238673	2033-06-17		Drug product	2016-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-001	10047117	2033-09-06	U-1854		2018-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-001	10052337	2036-04-26		Drug product	2018-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-001	10751349	2036-04-26		Drug product	2020-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-001	10758549	2036-04-26	U-2945		2020-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	10174073	2033-06-17		Drug substance	2019-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	9238673	2033-06-17		Drug product	2016-06-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	10047117	2033-09-06	U-1854		2018-11-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	10052337	2036-04-26		Drug product	2018-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	10751349	2036-04-26		Drug product	2020-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207999-002	10758549	2036-04-26	U-2945		2020-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207999-001	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-001	10174073	2033-06-17		Drug substance	2019-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-001	9238673	2033-06-17		Drug product	2016-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-001	10047117	2033-09-06	U-1854		2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-001	10052337	2036-04-26		Drug product	2018-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-001	10751349	2036-04-26		Drug product	2020-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-001	10758549	2036-04-26	U-2945		2020-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	10174073	2033-06-17		Drug substance	2019-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	9238673	2033-06-17		Drug product	2016-06-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	10047117	2033-09-06	U-1854		2018-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	10052337	2036-04-26		Drug product	2018-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	10751349	2036-04-26		Drug product	2020-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207999-002	10758549	2036-04-26	U-2945		2020-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207999-001	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-001	10174073	2033-06-17		Drug substance	2019-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-001	9238673	2033-06-17		Drug product	2016-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-001	10047117	2033-09-06	U-1854		2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-001	10052337	2036-04-26		Drug product	2018-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-001	10751349	2036-04-26		Drug product	2020-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-001	10758549	2036-04-26	U-2945		2020-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-002	RE48286	2027-02-21		Drug substance, Drug product	2020-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-002	10174073	2033-06-17		Drug substance	2019-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-002	9238673	2033-06-17		Drug product	2016-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-002	10047117	2033-09-06	U-1854		2018-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207999-002	10052337	2036-04-26		Drug product	2018-11-08	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 2 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-07-19 19:46 UTC	2019-07	N207999-001	NCE	2021-05-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207999-001	ODE-119	2023-05-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207999-002	NCE	2021-05-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207999-002	ODE-119	2023-05-27	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N207999-001	ODE-119	2023-05-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N207999-002	ODE-119	2023-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207999-001	ODE-119	2023-05-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207999-002	ODE-119	2023-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207999-001	ODE-119	2023-05-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207999-002	ODE-119	2023-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207999-001	ODE-119	2023-05-27	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207999-002	ODE-119	2023-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207999-001	ODE-119	2023-05-27	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N207999-002	ODE-119	2023-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N207999-001	ODE-119	2023-05-27	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N207999-002	ODE-119	2023-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N207999-001	ODE-119	2023-05-27	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N207999-002	ODE-119	2023-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207999-001	ODE-119	2023-05-27	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N207999-002	ODE-119	2023-05-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N207999-001	ODE-119	2023-05-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N207999-002	ODE-119	2023-05-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207999-001	ODE-119	2023-05-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N207999-002	ODE-119	2023-05-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207999-001	ODE-119	2023-05-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207999-002	ODE-119	2023-05-27	`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
69516-005	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-005	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-005	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-005	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-005	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-005	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-005	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-005	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-010	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-010	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-010	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-010	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-010	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-010	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-010	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current
69516-010	Ocaliva	Obeticholic Acid	Intercept Pharmaceuticals Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
70275	SUPPL	2022-02-28
70271	SUPPL	2022-02-28
67660	SUPPL	2021-06-02
67659	SUPPL	2021-06-02
67622	SUPPL	2021-05-28
67617	SUPPL	2021-05-27
52293	SUPPL	2018-02-02
52239	SUPPL	2018-02-01
52238	SUPPL	2018-02-01
44969	ORIG	2016-07-08
43542	ORIG	2016-07-08
40609	ORIG	2016-05-31
32875	ORIG	2016-05-31