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)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003100657LynparzaNDAAstrazeneca Pharmaceuticals Lp2014-12-24OLAPARIBORALCAPSULENDA2061625e31a6a9-864f-4aba-8085-37ee1ddcd499

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA206162LYNPARZAASTRAZENECA PHARMACEUTICALS LP2014-12-19p8247416
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)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA206162_001RXOLAPARIB (50MG)ORALCAPSULEFalse2014-12-19LYNPARZA

patent(s)

#idexpiration dateapplication(s)
1p7151102 (view patent)2022-04-29NDA206162
2p7449464 (view patent)2024-10-11NDA206162
3p7981889 (view patent)2024-10-11NDA206162
4p8143241 (view patent)2027-08-12NDA206162
5p8247416 (view patent)2028-09-24NDA206162
6p8859562 (view patent)2031-08-04NDA206162
7p8912187 (view patent)2024-03-12NDA206162

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15e31a6a9-864f-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: 2014prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals LpMANUFACTURE2014-12-192003100657

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII