Afinitor

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): 10MG ^[RLD], 5MG
  


• 
  Manufacturer: NOVARTIS
  
  Approval date: July 9, 2010
  
  Strength(s): 2.5MG
  

Has a generic version of Afinitor been approved?

No. There is currently no therapeutically equivalent version of Afinitor available.

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
  
  
  
  • September 9, 2019
    
  
  



• 
  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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• 
  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
  
  

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:
  • October 29, 2013 - TREATMENT OF PATIENTS WITH SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) ASSOCIATED WITH TUBEROUS SCLEROSIS (TS) WHO REQUIRE THERAPEUTIC INTERVENTION BUT ARE NOT CANDIDATES FOR CURATIVE SURGICAL RESECTION.
  
  
  • March 30, 2014 - NEW CHEMICAL ENTITY
  
  
  • May 5, 2014 - FOR PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET) THAT ARE UNRESECTABLE, LOCALLY ADVANCED, OR METASTATIC.
  
  
  • October 29, 2017 - ORPHAN DRUG EXCLUSIVITY
  
  
  • May 5, 2018 - ORPHAN DRUG EXCLUSIVITY
  
  

See also...

• Afinitor Consumer Information (Drugs.com)
• Afinitor Consumer Information (Wolters Kluwer)
• Afinitor Consumer Information (Cerner Multum)
• Afinitor Advanced Consumer Information (Micromedex)
• Afinitor AHFS DI Monographs (ASHP)
• Everolimus Consumer Information (Wolters Kluwer)
• Everolimus Consumer Information (Cerner Multum)
• Everolimus Advanced Consumer Information (Micromedex)
• Everolimus AHFS DI Monographs (ASHP)