NDAORALCAPSULEPriority Review
Approved
Feb 2015
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Mechanism of Action
Kinase Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Clinical Trials (5)
A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma
Started Feb 2026
25 enrolled
Metastatic Renal Cell CarcinomaMetastatic Renal CancerRenal Cell Carcinoma+3 more
A Study to Understand the Patients Confirmed to Have Advanced or Metastatic Breast Cancer and Receiving Palbociclib Treatment Using a Real-world Database
Started Jun 2025
1,000 enrolled
Advanced or Metastatic Breast Cancer
A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma
Started Feb 2025
54 enrolled
Well Differentiated LiposarcomaDedifferentiated LiposarcomaLiposarcoma+6 more
A Study to Understand About the Study Medicine Palbociclib in Breast Cancer Patients After it is Out in the Japanese Market
Started Jan 2025
1,772 enrolled
Breast Neoplasms
A Study to Learn About the Relationship Between Hepatic Impairment and Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal-bow-sai-klib)
Started Aug 2024
733 enrolled
Breast Cancer
Loss of Exclusivity
LOE Date
Aug 8, 2034
102 months away
Patent Expiry
Aug 8, 2034
Exclusivity Expiry
Mar 16, 2029
Patent Records (4)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| RE47739 | Mar 5, 2027 | SubstanceProduct | — |
| RE47739*PED | Sep 5, 2027 | — | |
| 10723730 | Feb 8, 2034 | SubstanceProduct | — |
| 10723730*PED | Aug 8, 2034 | — |