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  1. pharmadog
  2. ›drugs
  3. ›Ibrance
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palbociclib

Marketedupdated 3mo ago
by $OTLC Oncotelic Therapeutics, Inc.
Approved
annual revenue · 2024–2024peak $4.4B
2024: $4.4B2024$4.4B
community read0 votes

🐶 often sniffed alongside

top 2
  • company$PFEPFIZER INC1 co-mentions · 1 sources
  • tagDrug Shortage1 co-mentions · 1 sources

indications

investigational
Breast Cancer

all catalysts(0)

nothing on the calendar yet

Trials studying palbociclib

  • phase3BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Diseaserecruitingn=1,056
  • phase2A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancerrecruitingn=316
  • phase3Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancerrecruitingn=788
  • phase2A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancerrecruitingn=1,132
  • —A Study to Understand About the Study Medicine Palbociclib in Breast Cancer Patients After it is Out in the Japanese Marketcompletedn=95,637
  • phase2DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)active not recruitingn=70
  • phase1A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumorsrecruitingn=234
  • phase3A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Canceractive not recruitingn=325
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Mar 5, 2027
205 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (30)

  • Feb 19, 2037patentUS 11065250*PED
  • Feb 19, 2037patentUS 11065250*PED
  • Feb 19, 2037patentUS 11065250*PED
  • Aug 19, 2036formulationUS 11065250
  • Aug 19, 2036formulationUS 11065250
  • Aug 19, 2036formulationUS 11065250
  • Aug 8, 2034patentUS 10723730*PED
  • Aug 8, 2034patentUS 10723730*PED
  • Aug 8, 2034patentUS 10723730*PED
  • Aug 8, 2034patentUS 10723730*PED
  • Aug 8, 2034patentUS 10723730*PED
  • Aug 8, 2034patentUS 10723730*PED
  • Feb 8, 2034compositionUS 10723730
  • Feb 8, 2034compositionUS 10723730
  • Feb 8, 2034compositionUS 10723730
  • Feb 8, 2034compositionUS 10723730
  • Feb 8, 2034compositionUS 10723730
  • Feb 8, 2034compositionUS 10723730
  • Sep 5, 2027patentUS RE47739*PED1.1y
  • Sep 5, 2027patentUS RE47739*PED1.1y
  • Sep 5, 2027patentUS RE47739*PED1.1y
  • Sep 5, 2027patentUS RE47739*PED1.1y
  • Sep 5, 2027patentUS RE47739*PED1.1y
  • Sep 5, 2027patentUS RE47739*PED1.1y
  • Mar 5, 2027compositionUS RE47739205d
  • Mar 5, 2027compositionUS RE47739205d
  • Mar 5, 2027compositionUS RE47739205d
  • Mar 5, 2027compositionUS RE47739205d
  • Mar 5, 2027compositionUS RE47739205d
  • Mar 5, 2027compositionUS RE47739205d

FDA exclusivities (12)

  • Mar 16, 2029PEDPediatric (6mo bonus)2.6y
  • Mar 16, 2029PEDPediatric (6mo bonus)2.6y
  • Mar 16, 2029PEDPediatric (6mo bonus)2.6y
  • Mar 16, 2029PEDPediatric (6mo bonus)2.6y
  • Mar 16, 2029PEDPediatric (6mo bonus)2.6y
  • Mar 16, 2029PEDPediatric (6mo bonus)2.6y
  • Sep 16, 2028M-14Method (3y)2.1y
  • Sep 16, 2028M-14Method (3y)2.1y
  • Sep 16, 2028M-14Method (3y)2.1y
  • Sep 16, 2028M-14Method (3y)2.1y
  • Sep 16, 2028M-14Method (3y)2.1y
  • Sep 16, 2028M-14Method (3y)2.1y

News(7)

  • Pfizer expands multibillion-dollar cost-cutting plan
    Hatched three years ago, the restructuring is now expected to deliver $1 billion in new cost reductions and save Pfizer another $1.5 billion by streamlining drug production.
    biopharma_dive · 7d ago
  • Celcuity gains FDA approval for closely watched breast cancer drug
    Still, shares fell by nearly 20% after the company revealed a delay in the coming launch of Revtorpyk. Details in the drug’s prescribing information surprised some analysts, too.
    biopharma_dive · 27d ago
  • Celcuity breast cancer drug misses ‘lofty’ expectations in ASCO-spotlighted trial
    Gedatolisib could “establish a new standard of care” for PIK3CA-mutated breast cancer, an investigator said, but the results nonetheless appeared to disappoint investors.
    biopharma_dive · 2mo ago
  • RallyBio tries again for reverse merger, this time with Avenzo
    It's the second attempt for the rare disease company, which initially announced plans to merge with Candid Therapeutics before the immune drug developer was bought by UCB.
    biopharma_dive · 2mo ago
  • The OncFive: Top Oncology Articles for the Week of 5/3
    The FDA clears zenocutuzumab in NRG1 fusion+ cholangiocarcinoma, accepts a taletrectinib NDA in ROS1+ NSCLC for review, and more.
    onclive · 3mo ago
  • Poll Results Highlight Breast Cancer Abstracts of Interest at ASCO 2026
    Readers share their opinions on some of the most talked-about breast cancer abstracts they’re looking forward to seeing at ASCO 2026.
    onclive · 3mo ago
  • ASCO 2026 HR+ and HER2+ Breast Cancer Preview: Read up on the Insights to Know Before You Go
    Breast cancer experts spotlight the abstracts they’re most excited to see at the 2026 ASCO Annual Meeting.
    onclive · 3mo ago
brand
Ibrance
generic
palbociclib
indication
Breast Cancer
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 1h ago
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