Application 209241

Type
NDA
Sponsor
NEUROCRINE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INGREZZAVALBENAZINE TOSYLATECAPSULE;ORALEQ 40MG BASEYesNo
002INGREZZAVALBENAZINE TOSYLATECAPSULE;ORALEQ 80MG BASEYesYes
003INGREZZAVALBENAZINE TOSYLATECAPSULE;ORALEQ 60MG BASEYesNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N209241-001INGREZZAVALBENAZINE TOSYLATEEQ 40MG BASECAPSULE / ORALABRLD2017-04-11
N209241-002INGREZZAVALBENAZINE TOSYLATEEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-04
N209241-003INGREZZAVALBENAZINE TOSYLATEEQ 60MG BASECAPSULE / ORALRLD2021-04-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N209241-001AB
N209241-002AB

Orange Book patents#

Current patent rows page 1 of 2 · 99 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N209241-00183576972027-11-08U-19952017-04-26
N209241-00183576972027-11-08U-30552017-04-26
N209241-00180396272031-04-11Drug substance, Drug product2017-04-26
N209241-001100659522036-10-28U-1995Drug substance, Drug product2018-09-26
N209241-001100659522036-10-28U-3055Drug substance, Drug product2018-09-26
N209241-001108440582036-10-28U-1995Drug substance, Drug product2020-12-18
N209241-001108440582036-10-28U-3055Drug substance, Drug product2020-12-18
N209241-001108511032036-10-28U-1995Drug substance, Drug product2020-12-18
N209241-001108511032036-10-28U-3055Drug substance, Drug product2020-12-18
N209241-001108511042036-10-28U-1995Drug substance2020-12-18
N209241-001108511042036-10-28U-3055Drug substance2020-12-18
N209241-001109069022036-12-22Drug substance, Drug product2021-03-03
N209241-001109069032036-12-22Drug substance, Drug product2021-03-03
N209241-001109198922036-12-22Drug substance, Drug product2021-03-03
N209241-001108571372037-10-10U-19952020-12-18
N209241-001108571482037-10-10U-19952020-12-18
N209241-001108746482037-10-10U-19952021-01-25
N209241-001108746482037-10-10U-30462021-01-25
N209241-001108746482037-10-10U-30552021-01-25
N209241-001109127712037-10-10U-19952021-03-03
N209241-001109127712037-10-10U-30552021-03-03
N209241-001109127712037-10-10U-30762021-03-03
N209241-001109529972037-10-10U-19952021-04-06
N209241-001109939412037-10-10U-19952021-05-19
N209241-001110400292037-10-10U-19952021-06-30
N209241-001114396292037-10-10U-30552023-09-14
N209241-001110269392038-09-18U-1995Drug product2021-06-30
N209241-001110269392038-09-18U-3055Drug product2021-06-30
N209241-001113115322038-09-18U-1995Drug product2022-05-17
N209241-001113115322038-09-18U-3055Drug product2022-05-17
N209241-001116541422038-11-14U-30552023-09-14
N209241-001110269312039-08-14U-19952021-06-30
N209241-001109401412040-08-10U-19952021-04-06
N209241-00283576972027-11-08U-19952017-10-27
N209241-00283576972027-11-08U-30552017-10-27
N209241-00280396272031-04-11Drug substance, Drug product2017-10-27
N209241-002100659522036-10-28U-1995Drug substance, Drug product2018-09-26
N209241-002100659522036-10-28U-3055Drug substance, Drug product2018-09-26
N209241-002108440582036-10-28U-1995Drug substance, Drug product2020-12-18
N209241-002108440582036-10-28U-3055Drug substance, Drug product2020-12-18
N209241-002108511032036-10-28U-1995Drug substance, Drug product2020-12-18
N209241-002108511032036-10-28U-3055Drug substance, Drug product2020-12-18
N209241-002108511042036-10-28U-1995Drug substance2020-12-18
N209241-002108511042036-10-28U-3055Drug substance2020-12-18
N209241-002109069022036-12-22Drug substance, Drug product2021-03-03
N209241-002109069032036-12-22Drug substance, Drug product2021-03-03
N209241-002109198922036-12-22Drug substance, Drug product2021-03-03
N209241-002108571372037-10-10U-19952020-12-18
N209241-002108571482037-10-10U-19952020-12-18
N209241-002108746482037-10-10U-19952021-01-25
N209241-002108746482037-10-10U-30462021-01-25
N209241-002108746482037-10-10U-30552021-01-25
N209241-002109127712037-10-10U-19952021-03-03
N209241-002109127712037-10-10U-30552021-03-03
N209241-002109127712037-10-10U-30762021-03-03
N209241-002109529972037-10-10U-19952021-04-06
N209241-002109939412037-10-10U-19952021-05-19
N209241-002110400292037-10-10U-19952021-06-30
N209241-002114396292037-10-10U-30552023-09-14
N209241-002110269392038-09-18U-1995Drug product2021-06-30
N209241-002110269392038-09-18U-3055Drug product2021-06-30
N209241-002113115322038-09-18U-1995Drug product2022-05-17
N209241-002113115322038-09-18U-3055Drug product2022-05-17
N209241-002116541422038-11-14U-30552023-09-14
N209241-002110269312039-08-14U-19952021-06-30
N209241-002109401412040-08-10U-19952021-04-06
N209241-00383576972027-11-08U-19952021-05-19
N209241-00383576972027-11-08U-30552021-05-19
N209241-00380396272031-04-11Drug substance, Drug product2021-05-19
N209241-003100659522036-10-28U-1995Drug substance, Drug product2021-05-19
N209241-003100659522036-10-28U-3055Drug substance, Drug product2021-05-19
N209241-003108440582036-10-28U-1995Drug substance, Drug product2021-05-19
N209241-003108440582036-10-28U-3055Drug substance, Drug product2021-05-19
N209241-003108511032036-10-28U-1995Drug substance, Drug product2021-05-19
N209241-003108511032036-10-28U-3055Drug substance, Drug product2021-05-19
N209241-003108511042036-10-28U-1995Drug substance2021-05-19
N209241-003108511042036-10-28U-3055Drug substance2021-05-19
N209241-003109069022036-12-22Drug substance, Drug product2021-05-19
N209241-003109069032036-12-22Drug substance, Drug product2021-05-19
N209241-003109198922036-12-22Drug substance, Drug product2021-05-19

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N209241-001I-9252026-08-18
N209241-001ODE-4402030-08-18
N209241-002I-9252026-08-18
N209241-002ODE-4402030-08-18
N209241-003I-9252026-08-18
N209241-003ODE-4402030-08-18

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 4 · 121 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-1184e616aacf4f…
2026-09-14 22:38:342026-08N209241-002INGREZZAEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-0484e616aacf4f…
2026-09-14 22:38:342026-08N209241-003INGREZZAEQ 60MG BASECAPSULE / ORALRLD2021-04-2384e616aacf4f…
2026-08-18 06:07:402026-07N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-11caaa826d4ba7…
2026-08-18 06:07:402026-07N209241-002INGREZZAEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-04caaa826d4ba7…
2026-08-18 06:07:402026-07N209241-003INGREZZAEQ 60MG BASECAPSULE / ORALRLD2021-04-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209241-002INGREZZAEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209241-003INGREZZAEQ 60MG BASECAPSULE / ORALRLD2021-04-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209241-002INGREZZAEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209241-003INGREZZAEQ 60MG BASECAPSULE / ORALRLD2021-04-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209241-002INGREZZAEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209241-003INGREZZAEQ 60MG BASECAPSULE / ORALRLD2021-04-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209241-002INGREZZAEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209241-003INGREZZAEQ 60MG BASECAPSULE / ORALRLD2021-04-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209241-002INGREZZAEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209241-003INGREZZAEQ 60MG BASECAPSULE / ORALABRLD2021-04-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209241-002INGREZZAEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209241-003INGREZZAEQ 60MG BASECAPSULE / ORALABRLD2021-04-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209241-002INGREZZAEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209241-003INGREZZAEQ 60MG BASECAPSULE / ORALABRLD2021-04-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209241-002INGREZZAEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209241-003INGREZZAEQ 60MG BASECAPSULE / ORALABRLD2021-04-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209241-002INGREZZAEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209241-003INGREZZAEQ 60MG BASECAPSULE / ORALABRLD2021-04-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N209241-002INGREZZAEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-04d06236e962d9…
2024-10-29 15:01 UTC2024-10N209241-003INGREZZAEQ 60MG BASECAPSULE / ORALABRLD2021-04-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209241-002INGREZZAEQ 80MG BASECAPSULE / ORALABRLD, RS2017-10-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209241-003INGREZZAEQ 60MG BASECAPSULE / ORALABRLD2021-04-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209241-001INGREZZAEQ 40MG BASECAPSULE / ORALABRLD2017-04-11301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N209241-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N209241-002AB184e616aacf4f…
2026-08-18 06:07:402026-07N209241-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N209241-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209241-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209241-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209241-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209241-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N209241-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209241-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209241-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209241-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209241-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209241-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209241-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209241-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209241-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N209241-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209241-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209241-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N209241-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209241-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209241-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N209241-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209241-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209241-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N209241-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N209241-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N209241-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N209241-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209241-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209241-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N209241-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209241-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N209241-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209241-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N209241-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N209241-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N209241-002AB18072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N209241-001AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 78 · 3,114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N209241-00183576972027-11-08U-30552017-04-2684e616aacf4f…
2026-09-14 22:38:342026-08N209241-00183576972027-11-08U-19952017-04-2684e616aacf4f…
2026-09-14 22:38:342026-08N209241-00180396272031-04-11Drug substance, Drug product2017-04-2684e616aacf4f…
2026-09-14 22:38:342026-08N209241-001100659522036-10-28U-1995Drug substance, Drug product2018-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N209241-001100659522036-10-28U-3055Drug substance, Drug product2018-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N209241-001108440582036-10-28U-1995Drug substance, Drug product2020-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-001108440582036-10-28U-3055Drug substance, Drug product2020-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-001108511032036-10-28U-1995Drug substance, Drug product2020-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-001108511032036-10-28U-3055Drug substance, Drug product2020-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-001108511042036-10-28U-1995Drug substance2020-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-001108511042036-10-28U-3055Drug substance2020-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-001109069022036-12-22Drug substance, Drug product2021-03-0384e616aacf4f…
2026-09-14 22:38:342026-08N209241-001109069032036-12-22Drug substance, Drug product2021-03-0384e616aacf4f…
2026-09-14 22:38:342026-08N209241-001109198922036-12-22Drug substance, Drug product2021-03-0384e616aacf4f…
2026-09-14 22:38:342026-08N209241-001108571372037-10-10U-19952020-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-001108571482037-10-10U-19952020-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-001108746482037-10-10U-19952021-01-2584e616aacf4f…
2026-09-14 22:38:342026-08N209241-001108746482037-10-10U-30462021-01-2584e616aacf4f…
2026-09-14 22:38:342026-08N209241-001108746482037-10-10U-30552021-01-2584e616aacf4f…
2026-09-14 22:38:342026-08N209241-001109127712037-10-10U-30552021-03-0384e616aacf4f…
2026-09-14 22:38:342026-08N209241-001109127712037-10-10U-19952021-03-0384e616aacf4f…
2026-09-14 22:38:342026-08N209241-001109127712037-10-10U-30762021-03-0384e616aacf4f…
2026-09-14 22:38:342026-08N209241-001109529972037-10-10U-19952021-04-0684e616aacf4f…
2026-09-14 22:38:342026-08N209241-001109939412037-10-10U-19952021-05-1984e616aacf4f…
2026-09-14 22:38:342026-08N209241-001110400292037-10-10U-19952021-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N209241-001114396292037-10-10U-30552023-09-1484e616aacf4f…
2026-09-14 22:38:342026-08N209241-001110269392038-09-18U-3055Drug product2021-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N209241-001110269392038-09-18U-1995Drug product2021-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N209241-001113115322038-09-18U-1995Drug product2022-05-1784e616aacf4f…
2026-09-14 22:38:342026-08N209241-001113115322038-09-18U-3055Drug product2022-05-1784e616aacf4f…
2026-09-14 22:38:342026-08N209241-001116541422038-11-14U-30552023-09-1484e616aacf4f…
2026-09-14 22:38:342026-08N209241-001110269312039-08-14U-19952021-06-3084e616aacf4f…
2026-09-14 22:38:342026-08N209241-001109401412040-08-10U-19952021-04-0684e616aacf4f…
2026-09-14 22:38:342026-08N209241-00283576972027-11-08U-19952017-10-2784e616aacf4f…
2026-09-14 22:38:342026-08N209241-00283576972027-11-08U-30552017-10-2784e616aacf4f…
2026-09-14 22:38:342026-08N209241-00280396272031-04-11Drug substance, Drug product2017-10-2784e616aacf4f…
2026-09-14 22:38:342026-08N209241-002100659522036-10-28U-1995Drug substance, Drug product2018-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N209241-002100659522036-10-28U-3055Drug substance, Drug product2018-09-2684e616aacf4f…
2026-09-14 22:38:342026-08N209241-002108440582036-10-28U-1995Drug substance, Drug product2020-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-002108440582036-10-28U-3055Drug substance, Drug product2020-12-1884e616aacf4f…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N209241-001I-9252026-08-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-001ODE-4402030-08-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-002I-9252026-08-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-002ODE-4402030-08-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-003I-9252026-08-1884e616aacf4f…
2026-09-14 22:38:342026-08N209241-003ODE-4402030-08-1884e616aacf4f…
2026-08-18 06:07:402026-07N209241-001I-9252026-08-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209241-001ODE-4402030-08-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209241-002I-9252026-08-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209241-002ODE-4402030-08-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209241-003I-9252026-08-18caaa826d4ba7…
2026-08-18 06:07:402026-07N209241-003ODE-4402030-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N209241-001I-9252026-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209241-001ODE-4402030-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209241-002I-9252026-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209241-002ODE-4402030-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209241-003I-9252026-08-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N209241-003ODE-4402030-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209241-001I-9252026-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209241-001ODE-4402030-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209241-002I-9252026-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209241-002ODE-4402030-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209241-003I-9252026-08-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N209241-003ODE-4402030-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N209241-001I-9252026-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209241-001ODE-4402030-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209241-002I-9252026-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209241-002ODE-4402030-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209241-003I-9252026-08-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08N209241-003ODE-4402030-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209241-001I-9252026-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209241-001ODE-4402030-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209241-002I-9252026-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209241-002ODE-4402030-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209241-003I-9252026-08-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N209241-003ODE-4402030-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209241-001I-9252026-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209241-001ODE-4402030-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209241-002I-9252026-08-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N209241-002ODE-4402030-08-18b8a1b40f171c…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INGREZZAVALBENAZINENeurocrine Biosciences, Inc.4c970164-cafb-421f-9eb5-c226ef0a34172026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 209241
application number: NDA209241
ndc (product): 70370-1060
ndc (product): 70370-2048
ndc (product): 70370-1080
ndc (product): 70370-2040

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 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70370-1040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1040INGREZZAValbenazineNeurocrine Biosciences, INDACurrent
70370-1040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1048INGREZZAValbenazineNeurocrine Biosciences, INDACurrent
70370-1048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1060INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1060INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1060INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, INDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-1080INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, INDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2040INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, INDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent
70370-2048INGREZZAValbenazineNeurocrine Biosciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81053SUPPL 2025-02-06
81051SUPPL 2025-02-06
80967SUPPL 2025-02-06
80532SUPPL 2024-12-06
80514SUPPL 2024-12-05
75264SUPPL 2023-08-22
75146SUPPL 2023-08-21
72547SUPPL2022-11-02
71468SUPPL2022-06-28
67194SUPPL2021-04-28
67181SUPPL2021-04-27
62616SUPPL2020-04-21
62539SUPPL2020-04-10
59342SUPPL2019-08-05
59352SUPPL2019-07-16
55364SUPPL2018-08-30
55226SUPPL2018-08-20
48610ORIG2017-06-01
48609ORIG2017-06-01
47938ORIG2017-04-12
47937ORIG2017-04-12