drug
palbociclib
Marketedupdated 5mo 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
- phase2Study of AVZO-021 in Patients With Advanced Solid Tumors
- phase3A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
- phase1G1T48, an Oral SERD, Alone and in Combination With Palbociclib in ER-Positive, HER2-Negative Advanced 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
- phase3A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
- phase2A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
- phase1To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer
- phase2To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Mar 5, 2027
152 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*PED336d
- Sep 5, 2027patentUS RE47739*PED336d
- Sep 5, 2027patentUS RE47739*PED336d
- Sep 5, 2027patentUS RE47739*PED336d
- Sep 5, 2027patentUS RE47739*PED336d
- Sep 5, 2027patentUS RE47739*PED336d
- Mar 5, 2027compositionUS RE47739152d
- Mar 5, 2027compositionUS RE47739152d
- Mar 5, 2027compositionUS RE47739152d
- Mar 5, 2027compositionUS RE47739152d
- Mar 5, 2027compositionUS RE47739152d
- Mar 5, 2027compositionUS RE47739152d
FDA exclusivities (12)
- Mar 16, 2029PEDPediatric (6mo bonus)2.4y
- Mar 16, 2029PEDPediatric (6mo bonus)2.4y
- Mar 16, 2029PEDPediatric (6mo bonus)2.4y
- Mar 16, 2029PEDPediatric (6mo bonus)2.4y
- Mar 16, 2029PEDPediatric (6mo bonus)2.4y
- Mar 16, 2029PEDPediatric (6mo bonus)2.4y
- Sep 16, 2028M-14Method (3y)2.0y
- Sep 16, 2028M-14Method (3y)2.0y
- Sep 16, 2028M-14Method (3y)2.0y
- Sep 16, 2028M-14Method (3y)2.0y
- Sep 16, 2028M-14Method (3y)2.0y
- Sep 16, 2028M-14Method (3y)2.0y
News(10)
- AstraZeneca’s newly approved cancer pill fails late-stage study, blocking path to bigger marketSERENA-4 was assessing AstraZeneca’s Etcamah as a first-line option for certain patients with advanced breast cancer—a setting that could have meant a $2.9 billion opportunity for the drug.biospace · 19d ago
- AstraZeneca’s SERD pill overcomes adcomm defeat to win FDA nod in breast cancerThe approval opens up a “modest” market for AstraZeneca’s Etcamah, according to Leerink analysts, who nevertheless looked forward to an upcoming late-stage readout that could lead to a “significant…biospace · 25d ago
- FDA Grants Accelerated Approval to a New Breast Cancer TreatmentThe U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and getting ne…fda_press · 29d ago
- 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 · 2mo 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 · 2mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 4mo 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 · 5mo ago
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