Generic Afinitor Availability
Last updated on Oct 9, 2024.
See also: Generic Afinitor Disperz
Afinitor is a brand name of everolimus, approved by the FDA in the following formulation(s):
AFINITOR (everolimus - tablet;oral)
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Manufacturer: NOVARTIS
Approval date: March 30, 2009
Strength(s): 5MG [RLD] [AB], 10MG [RLD] [AB] -
Manufacturer: NOVARTIS
Approval date: July 9, 2010
Strength(s): 2.5MG [RLD] [AB] -
Manufacturer: NOVARTIS
Approval date: March 30, 2012
Strength(s): 7.5MG [RLD] [AB]
Has a generic version of Afinitor been approved?
A generic version of Afinitor has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Afinitor and have been approved by the FDA:
everolimus tablet;oral
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Manufacturer: BIOCON PHARMA
Approval date: February 11, 2021
Strength(s): 2.5MG [AB], 5MG [AB], 7.5MG [AB], 10MG [AB] -
Manufacturer: BRECKENRIDGE
Approval date: March 5, 2021
Strength(s): 2.5MG [AB], 5MG [AB], 7.5MG [AB], 10MG [AB] -
Manufacturer: ENDO OPERATIONS
Approval date: December 9, 2019
Strength(s): 2.5MG [AB], 5MG [AB], 7.5MG [AB] -
Manufacturer: ENDO OPERATIONS
Approval date: December 9, 2020
Strength(s): 10MG [AB] -
Manufacturer: HIKMA
Approval date: June 8, 2020
Strength(s): 2.5MG [AB], 5MG [AB], 7.5MG [AB] -
Manufacturer: HIKMA
Approval date: November 23, 2021
Strength(s): 10MG [AB] -
Manufacturer: MYLAN
Approval date: June 8, 2020
Strength(s): 2.5MG [AB], 5MG [AB], 7.5MG [AB], 10MG [AB] -
Manufacturer: TEVA PHARMS USA
Approval date: December 9, 2019
Strength(s): 2.5MG [AB], 5MG [AB], 7.5MG [AB], 10MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Afinitor. 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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Cancer treatment
Patent 8,410,131
Issued: April 2, 2013
Inventor(s): Lane Heidi & "OReilly Terence" & Wood Jeanette Marjorie
Assignee(s): Novartis Pharmaceuticals CorporationRapamycin derivatives have interesting effects in the treatment of solid tumors, optionally in combination with a chemotherapeutic agent.
Patent expiration dates:
- November 1, 2025✓
- November 1, 2025
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Cancer treatment
Patent 8410131*PED
Issued: April 2, 2013
Inventor(s): Lane Heidi & "OReilly Terence" & Wood Jeanette Marjorie
Assignee(s): Novartis Pharmaceuticals CorporationRapamycin derivatives have interesting effects in the treatment of solid tumors, optionally in combination with a chemotherapeutic agent.
Patent expiration dates:
- May 1, 2026✓
- May 1, 2026
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Neuroendocrine tumor treatment
Patent 9,006,224
Issued: April 14, 2015
Inventor(s): Marks Peter Wayne & Lebwohl David
Assignee(s): Novartis AGA method for treating endocrine tumors by administration of an mTOR inhibitor, optionally in combination with another drug.
Patent expiration dates:
- July 1, 2028✓
- July 1, 2028
More about Afinitor (everolimus)
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- Drug class: mTOR 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. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.