FDA Orange Book · active-ingredient family
Palbociclib
Palbociclib is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:IBRANCE · NDA 212436
2
Brand (NDA)
1
Generics (ANDA)
6
Listed patents
12
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IBRANCERLD×3 | PFIZER | NDA 212436 | — | Nov 01, 2019 | |
| IBRANCERLD×3 | PFIZER | NDA 207103 | — | Feb 03, 2015 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PALBOCICLIB×3 | ZYDUS LIFESCIENCES | ANDA 215570 | — | Jun 05, 2024 |
Marketing exclusivity (12)
- 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
- 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
- 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
- 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
- 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
- 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 |
Palbociclib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
