drug
palbociclib
Marketedupdated 3mo agoby $OTLC Oncotelic Therapeutics, Inc.
Approvedannual revenue · 2024–2024peak $4.4B
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🐶 often sniffed alongside
top 2indications
investigational
Breast Cancer
all catalysts(0)
nothing on the calendar yet
Trials studying palbociclib
- phase3A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
- 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 Disease
- phase2A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
- 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 Cancer
- phase2A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
- —A Study to Understand About the Study Medicine Palbociclib in Breast Cancer Patients After it is Out in the Japanese Market
- phase2DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE)
- phase1A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors
Patent cliff
source: FDA Orange Bookfirst barrier falls
Mar 5, 2027
196 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*PED1.0y
- Sep 5, 2027patentUS RE47739*PED1.0y
- Sep 5, 2027patentUS RE47739*PED1.0y
- Sep 5, 2027patentUS RE47739*PED1.0y
- Sep 5, 2027patentUS RE47739*PED1.0y
- Sep 5, 2027patentUS RE47739*PED1.0y
- Mar 5, 2027compositionUS RE47739196d
- Mar 5, 2027compositionUS RE47739196d
- Mar 5, 2027compositionUS RE47739196d
- Mar 5, 2027compositionUS RE47739196d
- Mar 5, 2027compositionUS RE47739196d
- Mar 5, 2027compositionUS RE47739196d
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 planHatched 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 · 16d ago
- Celcuity gains FDA approval for closely watched breast cancer drugStill, 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 · 1mo ago
- Celcuity breast cancer drug misses ‘lofty’ expectations in ASCO-spotlighted trialGedatolisib 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 AvenzoIt'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 5/3The 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 2026Readers 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 GoBreast cancer experts spotlight the abstracts they’re most excited to see at the 2026 ASCO Annual Meeting.onclive · 3mo ago
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