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Generic Zortress Availability

Zortress is a brand name of everolimus, approved by the FDA in the following formulation(s):

ZORTRESS (everolimus - tablet;oral)

  • Manufacturer: NOVARTIS
    Approval date: April 20, 2010
    Strength(s): 0.25MG, 0.5MG, 0.75MG [RLD]

Has a generic version of Zortress been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zortress. 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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      Patent use: PROPHYLAXIS OF ALLOGRAFT REJECTION IN ADULT PATIENTS RECEIVING A LIVER TRANSPLANT
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      Drug substance
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      Drug product
    • September 9, 2019
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      Patent use: PROPHYLAXIS OF ORGAN REJECTION IN ADULT PATIENTS AT LOW-MODERATE IMMUNOLOGIC RISK RECEIVING A RENAL TRANSPLANT
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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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      Patent use: PROPHYLAXIS OF ALLOGRAFT REJECTION IN ADULT PATIENTS RECEIVING A LIVER TRANSPLANT
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      Drug product
    • July 12, 2016
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      Patent use: PROPHYLAXIS OF ORGAN REJECTION IN ADULT PATIENTS AT LOW-MODERATE IMMUNOLOGIC RISK RECEIVING A RENAL TRANSPLANT
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      Drug product
    • January 12, 2017
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      Pediatric exclusivity
  • Pharmaceutical compositions for the treatment of transplant rejection or autoimmune or inflammatory conditions comprising cyclosporin A and 40-0-(2-hydroxyethyl)-rapamycin
    Patent 6,239,124
    Issued: May 29, 2001
    Inventor(s): Zenke; Gerhard & Schuurman; Hendrik & Haeberlin; Barbara & Meinzer; Armin
    Assignee(s): Novartis AG
    A synergistic combination of an IL-2 transcription inhibitor (e.g., cyclosporin A or FK506) and 40-O-(2-hydroxyethyl)-rapamycin is provided, which is useful in the treatment and prevention of transplant rejection and also certain autoimmune and inflammatory diseases, together with novel pharmaceutical compositions comprising an IL-2 transcription inhibitor in combination with a rapamycin, e.g., 40-O-(2-hydroxyethyl)-rapamycin.
    Patent expiration dates:
    • August 11, 2017
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      Patent use: PROPHYLAXIS OF ORGAN REJECTION IN ADULT PATIENTS AT LOW-MODERATE IMMUNOLOGIC RISK RECEIVING A RENAL TRANSPLANT
    • February 11, 2018
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      Pediatric exclusivity
  • Pharmaceutical compositions for the treatment of transplant rejection, autoimmune or inflammatory conditions comprising cyclosporin a and 40-O-(2-hydroxyethyl)-rapamycin
    Patent 6,455,518
    Issued: September 24, 2002
    Inventor(s): Gerhard; Zenke & Hendrik; Schuurman & Barbara; Haeberlin & Armin; Meinzer
    Assignee(s): Novartis AG
    A synergistic combination of an IL-2 transcription inhibitor (e.g., cyclosporin A or FK506) and 40-O-(2-hydroxyethyl)-rapamycin is provided, which is useful in the treatment and prevention of transplant rejection and also certain autoimmune and inflammatory diseases, together with novel pharmaceutical compositions comprising an IL-2 transcription inhibitor in combination with a rapamycin, e.g., 40-O-(2-hydroxyethyl)-rapamycin.
    Patent expiration dates:
    • July 29, 2017
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      Patent use: PROPHYLAXIS OF ALLOGRAFT REJECTION IN ADULT PATIENTS RECEIVING A LIVER TRANSPLANT
    • July 29, 2017
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      Patent use: PROPHYLAXIS OF ORGAN REJECTION IN ADULT PATIENTS AT LOW-MODERATE IMMUNOLOGIC RISK RECEIVING A RENAL TRANSPLANT
    • January 29, 2018
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      Pediatric exclusivity

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:
    • February 15, 2016 - PROPHYLAXIS OF ALLOGRAFT REJECTION IN ADULT PATIENTS RECEIVING A LIVER TRANSPLANT

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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