Palbociclib Patent Expiration

Palbociclib is Used for treating HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant. It was first introduced by Pfizer Inc in its drug Ibrance on Feb 3, 2015. 2 different companies have introduced drugs containing Palbociclib.


Palbociclib Patents

Given below is the list of patents protecting Palbociclib, along with the drug name that holds that patent and the company name owning that drug.

Filter patents by

NEW
Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Ibrance US11065250

(Pediatric)

Solid Dosage Forms Of Palbociclib Feb 19, 2037 Pfizer
Ibrance US11065250 Solid dosage forms of palbociclib Aug 19, 2036 Pfizer
Ibrance US10723730

(Pediatric)

Solid Forms Of A Selective Cdk4/6 Inhibitor Aug 08, 2034 Pfizer
Ibrance US10723730 Solid forms of a selective CDK4/6 inhibitor Feb 08, 2034 Pfizer
Ibrance USRE47739

(Pediatric)

Sep 05, 2027 Pfizer
Ibrance USRE47739 2-(pyridin-2-ylamino)-pyrido[2,3-D]pyrimidin-7-ones Mar 05, 2027 Pfizer
Ibrance US6936612 2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones Jan 16, 2023

(Expired)

Pfizer
Ibrance US7208489 2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones Jan 16, 2023

(Expired)

Pfizer
Ibrance US7456168 2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones Jan 16, 2023

(Expired)

Pfizer



Palbociclib's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List



Clinical Trials

Recent Clinical Trials on Palbociclib:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced Breast Cancer G1 Therapeutics, Inc. NA COMPLETED
(Sep 1, 2026)
PHASE1
Palbociclib and INCMGA00012 in People With Advanced Liposarcoma Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor Washington University School of Medicine NA RECRUITING
(Sep 1, 2026)
PHASE3
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors UNC Lineberger Comprehensive Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE1
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer Eisai Inc. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer Royal Marsden NHS Foundation Trust NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC) National Cancer Institute (NCI) NA RECRUITING
(Jul 27, 2026)
PHASE1, PHASE2
Palbociclib and Pembrolizumab In Central Nervous System Metastases Massachusetts General Hospital NA RECRUITING
(Jul 1, 2026)
PHASE2
Testing Palbociclib (PD-0332991) as a Potential Targeted Treatment in Cancers With CCND1, 2, 3 Amplification (MATCH-Subprotocol Z1B) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Testing Palbociclib (PD-0332991) as Potentially Targeting Treatment in Cancers With CDK4 or CDK6 Amplification (MATCH - Subprotocol Z1C) National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
PALbociclib CoLlaborative Adjuvant Study Alliance Foundation Trials, LLC. NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma Alliance for Clinical Trials in Oncology NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Palbociclib and Pembrolizumab in Sarcoma John Rieth NA RECRUITING
(May 1, 2026)
PHASE1
A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCEĀ®) in Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer Arvinas Estrogen Receptor, Inc. NA COMPLETED
(Apr 1, 2026)
PHASE1, PHASE2
Avelumab or Hydroxychloroquine With or Without Palbociclib to Eliminate Dormant Breast Cancer Abramson Cancer Center at Penn Medicine NA RECRUITING
(Apr 1, 2026)
PHASE2
Palbociclib in Patients With Metastatic Castration-Resistant Prostate Cancer Canadian Cancer Trials Group NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Neoadjuvant Camrelizumab With Palbociclib for Resectable Esophageal Squamous Cell Carcinomas West China Hospital NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE1


Palbociclib Generic API Manufacturers

Several generic applications have been filed for Palbociclib.

Given below is the list of companies who have filed for Palbociclib generic, along with the locations of their manufacturing plants worldwide.


Palbociclib News

New Gelatin Hydrogel Created for Simultaneous Delivery of ARV-471 and Palbociclib in Breast Cancer Treatment

30 Nov, 2025

Medicare to Reduce Drug Prices by as Much as 85% for Treatments Related to Weight Loss, Cancer, Asthma, and Other Conditions

26 Nov, 2025

Data indicates that Health Canada is experiencing delays in the approval process for generic medications.

06 Aug, 2025

See More