Orange Book product · Brand (NDA)
IBRANCE
PALBOCICLIB
At a glance
Nov 01, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 01, 2019
6 yr 9 mo ago
Today
Patent RE47739 expires
Listed drug substance patent expiration.
Mar 05, 2027
in 9 mo
Patent RE47739*PED expires
Listed listed patent expiration.
Sep 05, 2027
in 1 yr 3 mo
Exclusivity ends · M-14
New use / labeling-change exclusivity (3 years)
Sep 16, 2028
in 2 yr 3 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Mar 16, 2029
in 2 yr 9 mo
Patent 10723730 expires
Listed drug substance patent expiration.
Feb 08, 2034
in 7 yr 9 mo
Patent 10723730*PED expires
Listed listed patent expiration.
Aug 08, 2034
in 8 yr 3 mo
Patent 11065250 expires
Listed drug product patent expiration.
Aug 19, 2036
in 10 yr 4 mo
Patent 11065250*PED expires
Listed listed patent expiration.
Feb 19, 2037
in 10 yr 10 mo
Pharmaceutical detail
Active ingredient
PALBOCICLIB
Strength
75MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 212436
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 (2)
- M-14New use / labeling-change exclusivity (3 years)
Sep 16, 2028
in 2 yr 3 mo
- PEDPediatric exclusivity (adds 6 months)
Mar 16, 2029
in 2 yr 9 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE47739 | Mar 05, 2027 | in 9 mo | SubstanceProduct |
| RE47739*PED | Sep 05, 2027 | in 1 yr 3 mo | |
| 10723730 | Feb 08, 2034 | in 7 yr 9 mo | SubstanceProduct |
| 10723730*PED | Aug 08, 2034 | in 8 yr 3 mo | |
| 11065250 | Aug 19, 2036 | in 10 yr 4 mo | Product |
| 11065250*PED | Feb 19, 2037 | in 10 yr 10 mo |
