Orange Book product · Brand (NDA)
RUBRACA
RUCAPARIB CAMSYLATE
At a glance
Dec 19, 2016
Approved
Brand (NDA)
Application
Not listed
TE code
19
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 2016
9 yr 8 mo ago
Today
Patent 8071579 expires
Listed method-of-use patent (U-2273) expiration.
Aug 12, 2027
in 1 yr 2 mo
Patent 8071579 expires
Listed method-of-use patent (U-2012) expiration.
Aug 12, 2027
in 1 yr 2 mo
Patent 8071579 expires
Listed method-of-use patent (U-2830) expiration.
Aug 12, 2027
in 1 yr 2 mo
Patent 8143241 expires
Listed method-of-use patent (U-2012) expiration.
Aug 12, 2027
in 1 yr 2 mo
Patent 8143241 expires
Listed method-of-use patent (U-2273) expiration.
Aug 12, 2027
in 1 yr 2 mo
Patent 8143241 expires
Listed method-of-use patent (U-2830) expiration.
Aug 12, 2027
in 1 yr 2 mo
Exclusivity ends · I-982
New indication exclusivity (3 years)
Dec 17, 2028
in 2 yr 6 mo
Patent 10278974 expires
Listed drug product patent expiration.
Feb 10, 2031
in 4 yr 9 mo
Patent 8754072 expires
Listed drug substance patent expiration.
Feb 10, 2031
in 4 yr 9 mo
Patent 9045487 expires
Listed drug substance patent expiration.
Feb 10, 2031
in 4 yr 9 mo
Patent 9861638 expires
Listed method-of-use patent (U-2012) expiration.
Feb 10, 2031
in 4 yr 9 mo
Patent 9861638 expires
Listed method-of-use patent (U-2273) expiration.
Feb 10, 2031
in 4 yr 9 mo
Patent 8859562 expires
Listed method-of-use patent (U-2012) expiration.
Aug 04, 2031
in 5 yr 2 mo
Patent 8859562 expires
Listed method-of-use patent (U-2273) expiration.
Aug 04, 2031
in 5 yr 2 mo
Patent 8859562 expires
Listed method-of-use patent (U-2830) expiration.
Aug 04, 2031
in 5 yr 2 mo
Patent 10130636 expires
Listed method-of-use patent (U-2273) expiration.
Aug 17, 2035
in 9 yr 4 mo
Patent 10130636 expires
Listed method-of-use patent (U-2101) expiration.
Aug 17, 2035
in 9 yr 4 mo
Patent 10130636 expires
Listed method-of-use patent (U-2012) expiration.
Aug 17, 2035
in 9 yr 4 mo
Patent 10130636 expires
Listed method-of-use patent (U-2830) expiration.
Aug 17, 2035
in 9 yr 4 mo
Patent 9987285 expires
Listed drug product patent expiration.
Aug 17, 2035
in 9 yr 4 mo
Pharmaceutical detail
Active ingredient
RUCAPARIB CAMSYLATE
Strength
EQ 200MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 209115
Product number
001
Marketing status
RX
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.
Marketing exclusivity (1)
- I-982New indication exclusivity (3 years)
Dec 17, 2028
in 2 yr 6 mo
Listed patents (19)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8071579 | Aug 12, 2027 | in 1 yr 2 mo | U-2273 |
| 8071579 | Aug 12, 2027 | in 1 yr 2 mo | U-2012 |
| 8071579 | Aug 12, 2027 | in 1 yr 2 mo | U-2830 |
| 8143241 | Aug 12, 2027 | in 1 yr 2 mo | U-2012 |
| 8143241 | Aug 12, 2027 | in 1 yr 2 mo | U-2273 |
| 8143241 | Aug 12, 2027 | in 1 yr 2 mo | U-2830 |
| 10278974 | Feb 10, 2031 | in 4 yr 9 mo | Product |
| 8754072 | Feb 10, 2031 | in 4 yr 9 mo | SubstanceProduct |
| 9045487 | Feb 10, 2031 | in 4 yr 9 mo | SubstanceProduct |
| 9861638 | Feb 10, 2031 | in 4 yr 9 mo | U-2012 |
| 9861638 | Feb 10, 2031 | in 4 yr 9 mo | U-2273 |
| 8859562 | Aug 04, 2031 | in 5 yr 2 mo | U-2012 |
| 8859562 | Aug 04, 2031 | in 5 yr 2 mo | U-2273 |
| 8859562 | Aug 04, 2031 | in 5 yr 2 mo | U-2830 |
| 10130636 | Aug 17, 2035 | in 9 yr 4 mo | U-2273 |
| 10130636 | Aug 17, 2035 | in 9 yr 4 mo | U-2101 |
| 10130636 | Aug 17, 2035 | in 9 yr 4 mo | U-2012 |
| 10130636 | Aug 17, 2035 | in 9 yr 4 mo | U-2830 |
| 9987285 | Aug 17, 2035 | in 9 yr 4 mo | Product |
