Vijoice is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 4 US drug patents filed from 2022 to 2025 out of which none have expired yet. Vijoice's patents have been open to challenges since 25 May, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 17, 2037. Details of Vijoice'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. | |||
| US8227462 | Pyrrolidine-1,2-dicarboxamide derivatives |
Apr, 2033
(7 years from now) | Active |
| US8476268 | Pyrrolidine-1,2-dicarboxamide derivatives |
Sep, 2029
(3 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). | |||
| US12427141 | Byl719 (Alpelisib) For Use In The Treatment Of Pik3Ca-Related Overgrowth Spectrum (Pros-Cloves Syndrome) |
Feb, 2037
(10 years from now) | Active |
| US11433059 | Byl719 (Alpelisib) For Use In The Treatment Of Pik3Ca-Related Overgrowth Spectrum (Pros-Cloves Syndrome) |
Feb, 2037
(10 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Vijoice's patents.
Latest Legal Activities on Vijoice's Patents
Given below is the list of recent legal activities going on the following patents of Vijoice.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification | 18 Sep, 2025 | US12427141 |
| Issue Notification Mailed | 17 Sep, 2025 | US12427141 |
| Mail Response to 312 Amendment (PTO-271) | 04 Sep, 2025 | US12427141 |
| Email Notification | 04 Sep, 2025 | US12427141 |
| Dispatch to FDC | 04 Sep, 2025 | US12427141 |
| Response to Amendment under Rule 312 | 03 Sep, 2025 | US12427141 |
| Amendment after Notice of Allowance (Rule 312) | 02 Sep, 2025 | US12427141 |
| Mail PUB other miscellaneous communication to applicant | 08 Aug, 2025 | US12427141 |
| Email Notification | 08 Aug, 2025 | US12427141 |
| PUB Other miscellaneous communication to applicant | 07 Aug, 2025 | US12427141 |
FDA has granted several exclusivities to Vijoice. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Vijoice, 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
Vijoice.
Exclusivity Information
Vijoice holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Vijoice's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 24, 2024 |
| Orphan Drug Exclusivity(ODE-396) | Apr 05, 2029 |
US patents provide insights into the exclusivity only within the United States, but
Vijoice 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 Vijoice's family patents as well as insights into
ongoing legal events
on those patents.
Vijoice's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vijoice's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 17, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vijoice Generics:
There are no approved generic versions for Vijoice as of now.
Alternative Brands for Vijoice
There are several other brand drugs using the same active ingredient (Alpelisib) as Vijoice. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Novartis |
|
About Vijoice
Vijoice is a drug owned by Novartis Pharmaceuticals Corp. Vijoice uses Alpelisib as an active ingredient. Vijoice was launched by Novartis in 2022.
Approval Date:
Vijoice was approved by FDA for market use on 05 April, 2022.
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 Vijoice is 05 April, 2022, its NCE-1 date is estimated to be 25 May, 2023.
Active Ingredient:
Vijoice uses Alpelisib as the active ingredient. Check out other Drugs and Companies using Alpelisib ingredient
Dosage:
Vijoice is available in the following dosage forms - granules form for oral use, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG | TABLET | Prescription | ORAL |
| 50MG/PACKET | GRANULES | Prescription | ORAL |
| 200MG | TABLET | Prescription | ORAL |
| 125MG | TABLET | Prescription | ORAL |