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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 [RLD] [AB], 0.5MG [RLD] [AB], 0.75MG [RLD] [AB]

Has a generic version of Zortress been approved?

A generic version of Zortress 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 Zortress and have been approved by the FDA:

everolimus tablet;oral

  • Manufacturer: WEST-WARD PHARMS INT
    Approval date: April 12, 2018
    Strength(s): 0.25MG [AB], 0.5MG [AB], 0.75MG [AB]

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: Generic Drug FAQs.

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
      ✓ 
      Patent use: PROPHYLAXIS OF ALLOGRAFT REJECTION IN ADULT PATIENTS RECEIVING A LIVER TRANSPLANT
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      Drug substance
      ✓ 
      Drug product
    • September 9, 2019
      ✓ 
      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 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:

    • January 29, 2018
      ✓ 
      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:

    • January 29, 2018
      ✓ 
      Pediatric exclusivity

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) 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 (i.e., AB1, AB2, AB3, etc.). 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.
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