drug
alpelisib
Marketedupdated 3mo agoby $NVS NOVARTIS AG
Approvedcommunity read0 votes
all catalysts(0)
nothing on the calendar yet
Trials studying alpelisib
- phase2A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer
- phase3Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
- phase3Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.
- phase3A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
- phase2Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
- phase2EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)
- phase3Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
- phase1Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jan 18, 2027
159 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (22)
- Feb 17, 2037method-of-use (U-4359)US 11433059
- Feb 17, 2037method-of-use (U-4359)US 11433059
- Feb 17, 2037method-of-use (U-4359)US 11433059
- Feb 17, 2037method-of-use (U-4359)US 11433059
- Feb 17, 2037method-of-use (U-4288)US 12427141
- Feb 17, 2037method-of-use (U-4288)US 12427141
- Feb 17, 2037method-of-use (U-4288)US 12427141
- Feb 17, 2037method-of-use (U-4288)US 12427141
- Apr 29, 2033compositionUS 8227462
- Apr 29, 2033compositionUS 8227462
- Apr 29, 2033compositionUS 8227462
- Apr 29, 2033compositionUS 8227462
- Apr 29, 2033compositionUS 8227462
- Apr 29, 2033compositionUS 8227462
- Apr 29, 2033compositionUS 8227462
- Sep 10, 2029compositionUS 84762683.1y
- Sep 10, 2029compositionUS 84762683.1y
- Sep 10, 2029compositionUS 84762683.1y
- Sep 10, 2029compositionUS 84762683.1y
- Sep 10, 2029compositionUS 84762683.1y
- Sep 10, 2029compositionUS 84762683.1y
- Sep 10, 2029compositionUS 84762683.1y
FDA exclusivities (6)
- Apr 5, 2029ODE-396Orphan Drug (7y)2.6y
- Apr 5, 2029ODE-396Orphan Drug (7y)2.6y
- Apr 5, 2029ODE-396Orphan Drug (7y)2.6y
- Jan 18, 2027I-937Indication (3y)159d
- Jan 18, 2027I-937Indication (3y)159d
- Jan 18, 2027I-937Indication (3y)159d
News(3)
- 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
- 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
- Celcuity strengthens case for ASCO-spotlighted breast cancer drugThe new data could support a broader approval submission for a therapy that is already under review and set to be showcased at the year’s biggest meeting for cancer research.biopharma_dive · 3mo ago
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