Alpelisib Patent Expiration

Alpelisib was first introduced by Novartis Pharmaceuticals Corp in its drug Piqray on May 24, 2019. Another drug containing Alpelisib is Vijoice.


Alpelisib Patents

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

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Vijoice US11433059 Byl719 (Alpelisib) For Use In The Treatment Of Pik3Ca-Related Overgrowth Spectrum (Pros-Cloves Syndrome) Feb 17, 2037 Novartis
Vijoice US12427141 Byl719 (Alpelisib) For Use In The Treatment Of Pik3Ca-Related Overgrowth Spectrum (Pros-Cloves Syndrome) Feb 17, 2037 Novartis
Piqray US8227462 Pyrrolidine-1,2-dicarboxamide derivatives Apr 29, 2033 Novartis
Vijoice US8227462 Pyrrolidine-1,2-dicarboxamide derivatives Apr 29, 2033 Novartis
Piqray US8476268 Pyrrolidine-1,2-dicarboxamide derivatives Sep 10, 2029 Novartis
Vijoice US8476268 Pyrrolidine-1,2-dicarboxamide derivatives Sep 10, 2029 Novartis



Alpelisib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Alpelisib:

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
Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Study 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. Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer Olema Pharmaceuticals, Inc. NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial National Cancer Institute (NCI) NA RECRUITING
(Sep 1, 2026)
PHASE2
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation. Novartis Pharmaceuticals NA RECRUITING
(Sep 1, 2026)
PHASE2, PHASE3
EPIK-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) Novartis Pharmaceuticals NA RECRUITING
(Sep 1, 2026)
PHASE2
Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety. Novartis Pharmaceuticals NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
Alpelisib Challenge Test (ACT) Columbia University NA RECRUITING
(Sep 1, 2026)
PHASE1
Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss Novartis Pharmaceuticals NA TERMINATED
(Aug 1, 2026)
PHASE3
Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) Kura Oncology, Inc. NA COMPLETED
(Aug 1, 2026)
PHASE1, PHASE2
Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A 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 Hoffmann-La Roche NA RECRUITING
(Aug 1, 2026)
PHASE3
Human Models of Selective Insulin Resistance: Alpelisib, Part I Columbia University NA RECRUITING
(Aug 1, 2026)
PHASE1
Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA) M.D. Anderson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE1
A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer GOG Foundation NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant Novartis Pharmaceuticals NA TERMINATED
(Jun 1, 2026)
PHASE3
Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations M.D. Anderson Cancer Center NA TERMINATED
(Jun 1, 2026)
PHASE2
Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected Novartis Pharmaceuticals NA TERMINATED
(Jun 1, 2026)
PHASE3
Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC) The Methodist Hospital Research Institute NA RECRUITING
(Jun 1, 2026)
PHASE2
SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast) Borstkanker Onderzoek Groep NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer University of Kansas Medical Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer SynDevRx, Inc. NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations Murdoch Childrens Research Institute NA RECRUITING
(Apr 1, 2026)
PHASE2
24VA022; VATCH Alpelisib for TIE2/PIK3CA Pathway VAs Children's Hospital of Philadelphia NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. Criterium, Inc. NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
A Study to Evaluate the Efficacy and Safety of Everolimus in Patients With Teratment-refractory Vascular Anomalies Yonsei University NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE2


Alpelisib Generic API Manufacturers

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