Inavolisib Patent Expiration

Inavolisib was first introduced by Genentech Inc in its drug Itovebi on Oct 10, 2024.


Inavolisib Patents

Given below is the list of patents protecting Inavolisib, 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
Itovebi US12410189 Polymorphs And Solid Forms Of (S)-2-2((2-((S)-4-(Difluoromethyl)-2-Oxooxazolidin-3-Yl)-5,6-Dihydrobenzo[F]Imidazo[1,2-D][1,4]Oxazepin-9- Yl)Amino)Propanamide, And Methods Of Production Jun 14, 2038 Genentech Inc
Itovebi US11028100 Polymorphs and solid forms of (s)-2-((2-((s)-4-(difluoromethyl)-2-oxooxazolidin-3-yl)-5,6-dihydrobenzo[f]imidazo[1,2-d][1,4]oxazepin-9-yl)amino)propanamide, and methods of production Apr 26, 2038 Genentech Inc
Itovebi US10851091 Benzoxazepin oxazolidinone compounds and methods of use Jul 01, 2036 Genentech Inc
Itovebi US11760753 Benzoxazepin oxazolidinone compounds and methods of use Jul 01, 2036 Genentech Inc
Itovebi US9650393 Benzoxazepin oxazolidinone compounds and methods of use Jul 01, 2036 Genentech Inc
Itovebi US8242104 Benzoxazepin P13K inhibitor compounds and methods of use Sep 27, 2030 Genentech Inc
Itovebi US8343955 Benzoxazepin PI3K inhibitor compounds and methods of use Sep 27, 2030 Genentech Inc



Inavolisib's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Inavolisib:

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
Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer GBG Forschungs GmbH NA RECRUITING
(Sep 1, 2026)
PHASE2
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer Hoffmann-La Roche NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the Pharmacokinetics (PK) of Inavolisib Genentech, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation Genentech, Inc. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab in PIK3CA-Mutated Cancers Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer Hoffmann-La Roche NA RECRUITING
(Aug 1, 2026)
PHASE2
A Multicenter, Single Arm Study to Evaluate the Preliminary Efficacy and Safety Profile of Inavolisib in Previously Treated Pancreatic Ductal Adenocarcinoma Patients Fudan University NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Inavolisib for PIK3CA Mutated Advanced Endometrial Cancer: MITO END-4 National Cancer Institute, Naples NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2


Inavolisib Generic API Manufacturers

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


Inavolisib News

Roche Holding AG: Managing Patent Expirations and Fostering Innovation in a Competitive Pharmaceutical Landscape

16 Aug, 2025

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