Ibrutinib Oral Capsule
- Brand(s)
- Imbruvica
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Pharmacyclics, Inc (2015-02-13)
- Oldest Current Product
- 2013-11-07
- License(s)
- NDA
- RxNORM
- ORAL CAPSULE\IBRUTINIB
- FDAOB
- ORAL\CAPSULE\IBRUTINIB
- SPL Active
- ORAL\CAPSULE\IBRUTINIB
- SPL Moiety
- ORAL\CAPSULE\IBRUTINIB
product(s) by strength(s)
ibrutinib 140 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 579620140 | Imbruvica | NDA | Pharmacyclics, Inc | 2013-11-07 | IBRUTINIB | ORAL | CAPSULE | NDA205552 | 0dfd0279-ff17-4ea9-89be-9803c71bab44 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA205552 | IMBRUVICA | PHARMACYCLICS INC | 2013-11-13 | p8497277, TREATMENT OF MANTLE CELL LYMPHOMA/ TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA/ TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA p8476284, TREATMENT OF MANTLE CELL LYMPHOMA/ TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA p8999999, TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/ TREATMENT FRO CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION p8957079, SUBSTANCE p8697711, SUBSTANCE p9125889, FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA p8754091, SUBSTANCE p8754090, TREATMENT OF MANTLE CELL LYMPHOMA p8008309, SUBSTANCE p8703780, TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA p7514444, SUBSTANCE p8735403, SUBSTANCE | ORPHAN DRUG EXCLUSIVITY [2022-01-29] ORPHAN DRUG EXCLUSIVITY [2021-07-28] ORPHAN DRUG EXCLUSIVITY [2021-02-12] ORPHAN DRUG EXCLUSIVITY [2020-11-13] TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION [2017-07-28] FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM MACROGLOBULINEMIA [2018-01-29] TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY [2017-02-12] NEW CHEMICAL ENTITY [2018-11-13] | NDA205552_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA205552_001 | RX | IBRUTINIB (140MG) | ORAL | CAPSULE | True | 2013-11-13 | IMBRUVICA |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p7514444 (view patent) | 2026-12-28 | NDA205552 |
| 2 | p8008309 (view patent) | 2026-12-28 | NDA205552 |
| 3 | p8476284 (view patent) | 2026-12-28 | NDA205552 |
| 4 | p8497277 (view patent) | 2026-12-28 | NDA205552 |
| 5 | p8697711 (view patent) | 2026-12-28 | NDA205552 |
| 6 | p8703780 (view patent) | 2026-12-28 | NDA205552 |
| 7 | p8735403 (view patent) | 2026-12-28 | NDA205552 |
| 8 | p8754090 (view patent) | 2031-06-03 | NDA205552 |
| 9 | p8754091 (view patent) | 2026-12-28 | NDA205552 |
| 10 | p8957079 (view patent) | 2026-12-28 | NDA205552 |
| 11 | p8999999 (view patent) | 2031-06-03 | NDA205552 |
| 12 | p9125889 (view patent) | 2031-06-03 | NDA205552 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 0dfd0279-ff17-4ea9-89be-9803c71bab44 (view SPL) | These highlights do not include all the information needed to use IMBRUVICA safely and effectively. See full prescribing information for IMBRUVICA. IMBRUVICA (ibrutinib) capsules, for oral use Initial U.S. Approval: 2013 | prescription | Human Prescription | Pharmacyclics, Inc | ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK, PARTICLE SIZE REDUCTION | 2015-02-13 | 6 | 579620140 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII