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Generic Afinitor Availability

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)

  • Manufacturer: NOVARTIS
    Approval date: March 30, 2009
    Strength(s): 5MG, 10MG [RLD]
  • Manufacturer: NOVARTIS
    Approval date: July 9, 2010
    Strength(s): 2.5MG
  • Manufacturer: NOVARTIS
    Approval date: March 30, 2012
    Strength(s): 7.5MG

Has a generic version of Afinitor been approved?

No. There is currently no therapeutically equivalent version of Afinitor available in the United States.

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: About generic drugs.

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.

  • O-alkylated rapamycin derivatives and their use, particularly as immunosuppressants
    Patent 5,665,772
    Issued: September 9, 1997
    Inventor(s): Cottens; Sylvain & Sedrani; Richard
    Assignee(s): Sandoz Ltd.
    Novel derivatives of rapamycin, particularly 9-deoxorapamycins, 26-dihydro-rapamycins, and 40-0-substituted and 28,40-0,0-di-substituted rapamycins, are found to have pharmaceutical utility, particularly as an immunosuppressants.
    Patent expiration dates:
    • September 9, 2019
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      Drug substance
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      Drug product
    • March 9, 2020
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      Pediatric exclusivity
  • Pharmaceutical compositions comprising rafamycin coprecipitates
    Patent 6,004,973
    Issued: December 21, 1999
    Inventor(s): Guitard; Patrice & Haeberlin; Barbara & Link; Rainer & Richter; Friedrich
    Assignee(s): Novartis AG
    Disclosed are pharmaceutical compositions containing solid dispersions in the form of co-precipitates, which solid dispersions contain rapamycin and a carrier medium, and methods of treatment utilizing such pharmaceutical compositions.
    Patent expiration dates:
    • July 12, 2016
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      Drug product
    • January 12, 2017
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      Pediatric exclusivity
  • Macrolides
    Patent 7,297,703
    Issued: November 20, 2007
    Inventor(s): Navarro; Francois & Petit; Samuel & Stone; Guy
    Assignee(s): Novartis AG
    A mixture comprising a poly-ene macrolide and an antioxidant. Preferably, the poly-ene macrolide is rapamycin and the antioxidant is 2, 6-di-tert.-butyl-4-methylphenol. The presence of the antioxidant improves the stability of the poly-ene macrolide to oxidation.
    Patent expiration dates:
    • December 6, 2019
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      Drug product
    • June 6, 2020
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      Pediatric exclusivity
  • Macrolides
    Patent 7,741,338
    Issued: June 22, 2010
    Inventor(s): Navarro; Francois & Petit; Samuel & Stone; Guy
    Assignee(s): Novartis AG
    The invention relates to the stabilization of poly-ene macrolides and to a particular macrolide obtained in crystalline form.
    Patent expiration dates:
    • December 6, 2019
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      Drug product
  • Cancer treatment
    Patent 8,410,131
    Issued: April 2, 2013
    Assignee(s): Novartis Pharmaceuticals Corporation
    Rapamycin derivatives have interesting effects in the treatment of solid tumors, optionally in combination with a chemotherapeutic agent.
    Patent expiration dates:
    • November 1, 2025
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      Patent use: TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC), AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
    • May 1, 2026
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      Pediatric exclusivity
  • Treatment of solid tumors with rapamycin derivatives
    Patent 8,436,010
    Issued: May 7, 2013
    Assignee(s): Novartis Pharmaceuticals Corporation
    Rapamycin derivatives have interesting effects in the treatment of solid tumors, optionally in combination with a chemotherapeutic agent.
    Patent expiration dates:
    • February 22, 2022
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      Patent use: TREATMENT OF ADVANCED HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE BREAST CANCER IN COMBINATION WITH EXEMESTANE AFTER FAILURE OF TREATMENT WITH LETROZOLE OR ANASTROZOLE
    • August 22, 2022
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      Pediatric exclusivity
  • Treatment of solid tumors with rapamycin derivatives
    Patent 8,778,962
    Issued: July 15, 2014
    Assignee(s): Novartis Pharmaceuticals Corporation
    Rapamycin derivatives have interesting effects in the treatment of solid tumours, optionally in combination with a chemotherapeutic agent.
    Patent expiration dates:
    • February 18, 2022
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      Patent use: TREATMENT OF PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX (TSC) WHO HAVE SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) THAT REQUIRES THERAPEUTIC INTERVENTION BUT CANNOT BE CURATIVELY RESECTED.
    • August 18, 2022
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      Pediatric exclusivity
  • Neuroendocrine tumor treatment
    Patent 9,006,224
    Issued: April 14, 2015
    Assignee(s): Novartis AG
    A method for treating endocrine tumors by administration of an mTOR inhibitor, optionally in combination with another drug.
    Patent expiration dates:
    • July 1, 2028
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      Patent use: TREATMENT OF PATIENTS WITH PROGESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC

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:
    • July 20, 2015 - TREATMENT OF POSTMENOPAUSAL WOMEN WITH ADVANCED HORMONE RECEPTOR-POSITIVE,HER2-NEGATIVE BREAST CANCER (ADVANCED HR+BC) IN COMBINATION WITH EXEMESTANE, AFTER FAILURE OF TREATMENT WITH LETROZOLE OR ANASTROZOLE
    • October 26, 2015 - PEDIATRIC EXCLUSIVITY
    • October 29, 2017 - ORPHAN DRUG EXCLUSIVITY
    • April 29, 2018 - PEDIATRIC EXCLUSIVITY
    • May 5, 2018 - ORPHAN DRUG EXCLUSIVITY
    • November 5, 2018 - PEDIATRIC EXCLUSIVITY
    • February 26, 2019 - TREATMENT OF ADULT PATIENTS WITH PROGRESSIVE, WELL DIFFERENTIATED, NON-FUNCTIONAL NEUROENDOCRINE TUMORS (NET) OF GI OR LUNG ORIGIN WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC DISEASE
    • April 26, 2019 - ORPHAN DRUG EXCLUSIVITY
    • October 26, 2019 - PEDIATRIC EXCLUSIVITY

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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