olaparib Oral Capsule
- Brand(s)
- Lynparza
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Astrazeneca Pharmaceuticals Lp (2014-12-19)
- Oldest Current Product
- 2014-12-24
- License(s)
- NDA
- RxNORM
- ORAL CAPSULE\OLAPARIB
- FDAOB
- ORAL\CAPSULE\OLAPARIB
- SPL Active
- ORAL\CAPSULE\OLAPARIB
- SPL Moiety
- ORAL\CAPSULE\OLAPARIB
product(s) by strength(s)
olaparib 50 mg oral capsule
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 003100657 | Lynparza | NDA | Astrazeneca Pharmaceuticals Lp | 2014-12-24 | OLAPARIB | ORAL | CAPSULE | NDA206162 | 5e31a6a9-864f-4aba-8085-37ee1ddcd499 |
application(s)
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | NDA206162 | LYNPARZA | ASTRAZENECA PHARMACEUTICALS LP | 2014-12-19 | p8247416 p8143241, TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR p7981889, SUBSTANCE p8859562, TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR p7151102, SUBSTANCE p8912187, TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR p7449464, SUBSTANCE | ORPHAN DRUG EXCLUSIVITY [2021-12-19] NEW CHEMICAL ENTITY [2019-12-19] | NDA206162_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA206162_001 | RX | OLAPARIB (50MG) | ORAL | CAPSULE | False | 2014-12-19 | LYNPARZA |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p7151102 (view patent) | 2022-04-29 | NDA206162 |
| 2 | p7449464 (view patent) | 2024-10-11 | NDA206162 |
| 3 | p7981889 (view patent) | 2024-10-11 | NDA206162 |
| 4 | p8143241 (view patent) | 2027-08-12 | NDA206162 |
| 5 | p8247416 (view patent) | 2028-09-24 | NDA206162 |
| 6 | p8859562 (view patent) | 2031-08-04 | NDA206162 |
| 7 | p8912187 (view patent) | 2024-03-12 | NDA206162 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 5e31a6a9-864f-4aba-8085-37ee1ddcd499 (view SPL) | These highlights do not include all the information needed to use LYNPARZA safely and effectively. See full prescribing information for LYNPARZA. LYNPARZA (olaparib) capsules, for oral useInitial U.S. Approval: 2014 | prescription | Human Prescription | Astrazeneca Pharmaceuticals Lp | MANUFACTURE | 2014-12-19 | 2 | 003100657 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII