Generic Vijoice Availability
Last updated on Jan 8, 2025.
Vijoice is a brand name of alpelisib, approved by the FDA in the following formulation(s):
VIJOICE (alpelisib - granules;oral)
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Manufacturer: NOVARTIS
Approval date: April 24, 2024
Strength(s): 50MG/PACKET [RLD]
VIJOICE (alpelisib - tablet;oral)
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Manufacturer: NOVARTIS
Approval date: April 5, 2022
Strength(s): 50MG [RLD], 125MG [RLD], 200MG [RLD]
Has a generic version of Vijoice been approved?
No. There is currently no therapeutically equivalent version of Vijoice available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Vijoice. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Pyrrolidine-1,2-dicarboxamide derivatives
Patent 8,227,462
Issued: July 24, 2012
Inventor(s): Fairhurst Robin Alec & Guagnano Vito & Imbach Patricia & Caravatti Giorgio & Furet Pascal
Assignee(s): Novartis AGThe present invention relates to a compound of formula (I)
Patent expiration dates:
- April 29, 2033✓✓
- April 29, 2033
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Pyrrolidine-1,2-dicarboxamide derivatives
Patent 8,476,268
Issued: July 2, 2013
Inventor(s): Fairhurst Robin Alec & Guagnano Vito & Imbach-Weese Patricia & Caravatti Giorgio & Furet Pascal
Assignee(s): Novartis AGThe present invention relates to a compound of formula (I)
Patent expiration dates:
- September 10, 2029✓✓
- September 10, 2029
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- May 24, 2024 - NEW CHEMICAL ENTITY
- April 5, 2029 - TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH SEVERE MANIFESTATIONS OF PIK3CA-RELATED OVERGROWTH SPECTRUM (PROS) WHO REQUIRE SYSTEMIC THERAPY
More about Vijoice (alpelisib)
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- Drug class: PI3K inhibitors
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Glossary
Term | Definition |
---|---|
Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.