Orange Book product · Brand (NDA)
LYNPARZA
OLAPARIB
At a glance
Dec 19, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 2014
11 yr 8 mo ago
Today
Patent 8143241 expires
Listed method-of-use patent (U-1634) expiration.
Aug 12, 2027
in 1 yr 2 mo
Patent 8247416 expires
Listed drug substance patent expiration.
Sep 24, 2028
in 2 yr 4 mo
Patent 8859562 expires
Listed method-of-use patent (U-1634) expiration.
Aug 04, 2031
in 5 yr 2 mo
Pharmaceutical detail
Active ingredient
OLAPARIB
Strength
50MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 206162
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8143241 | Aug 12, 2027 | in 1 yr 2 mo | U-1634 |
| 8247416 | Sep 24, 2028 | in 2 yr 4 mo | Substance |
| 8859562 | Aug 04, 2031 | in 5 yr 2 mo | U-1634 |
