Itovebi is a drug owned by Genentech Inc. It is protected by 6 US drug patents filed in 2024 out of which none have expired yet. Itovebi's patents will be open to challenges from 10 October, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 26, 2038. Details of Itovebi's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| 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, 2038
(13 years from now) | Active |
| US9650393 | Benzoxazepin oxazolidinone compounds and methods of use |
Jul, 2036
(11 years from now) | Active |
| US10851091 | Benzoxazepin oxazolidinone compounds and methods of use |
Jul, 2036
(11 years from now) | Active |
| US8242104 | Benzoxazepin P13K inhibitor compounds and methods of use |
Sep, 2030
(5 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11760753 | Benzoxazepin oxazolidinone compounds and methods of use |
Jul, 2036
(11 years from now) | Active |
| US8343955 | Benzoxazepin PI3K inhibitor compounds and methods of use |
Sep, 2030
(5 years from now) | Active |
FDA has granted several exclusivities to Itovebi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Itovebi, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Itovebi.
Exclusivity Information
Itovebi holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Itovebi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 10, 2029 |
US patents provide insights into the exclusivity only within the United States, but Itovebi is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Itovebi's family patents as well as insights into ongoing legal events on those patents.
Itovebi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Itovebi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 26, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Itovebi Generics:
There are no approved generic versions for Itovebi as of now.
About Itovebi
Itovebi is a drug owned by Genentech Inc. Itovebi uses Inavolisib as an active ingredient. Itovebi was launched by Genentech Inc in 2024.
Approval Date:
Itovebi was approved by FDA for market use on 10 October, 2024.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Itovebi is 10 October, 2024, its NCE-1 date is estimated to be 10 October, 2028.
Active Ingredient:
Itovebi uses Inavolisib as the active ingredient. Check out other Drugs and Companies using Inavolisib ingredient
Dosage:
Itovebi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 9MG | TABLET | Prescription | ORAL |
| 3MG | TABLET | Prescription | ORAL |