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Generic Gilenya Availability

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

GILENYA (fingolimod hydrochloride - capsule;oral)

  • Manufacturer: NOVARTIS
    Approval date: September 21, 2010
    Strength(s): EQ 0.5MG BASE [RLD]
  • Manufacturer: NOVARTIS
    Approval date: May 11, 2018
    Strength(s): EQ 0.25MG BASE [RLD]

Has a generic version of Gilenya been approved?

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

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Gilenya. 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.

  • 2-amino-1,3-propanediol compound and immunosuppressant
    Patent 5,604,229
    Issued: February 18, 1997
    Inventor(s): Fujita; Tetsuro & Sasaki; Shigeo & Yoneta; Masahiko & Mishina; Tadashi & Adachi; Kunitomo & Chiba; Kenji
    Assignee(s): Yoshitomi Pharmaceutical Industries, Ltd. Taito Co., Ltd.

    2-Amino-1,3-propanediol compounds of the formula (I) ##STR1## wherein R is an optionally substituted straight- or branched carbon chain, an optionally substituted aryl, an optionally substituted cycloalkyl or the like, and R.sup.2, R.sup.3, R.sup.4 and R.sup.5 are the same or different and each is a hydrogen, an alkyl, an aralkyl, an acyl or an alkoxycarbonyl, pharmaceutically acceptable salts thereof and immunosuppressants comprising these compounds as active ingredients. The 2-amino-1,3-propanediol compounds of the present invention show immunosuppressive action and are useful for suppressing rejection in organ or bone marrow tranplantation, prevention and treatment of autoimmune diseases or as reagents for use in medicinal and pharmaceutical fields.

    Patent expiration dates:

    • February 18, 2019
      ✓ 
      Patent use: TREATMENT OF AUTOIMMUNE DISEASE
      ✓ 
      Drug substance
    • August 18, 2019
      ✓ 
      Pediatric exclusivity
  • Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol
    Patent 8,324,283
    Issued: December 4, 2012
    Inventor(s): Oomura; Tomoyuki & Pudipeddi; Madhusudhan & Ruegger; Colleen & Royce; Alan E & Sasaki; Masaki & Tamura; Tokuhiro
    Assignee(s): Novartis AG Mitsubishi Pharma Corporation

    A solid pharmaceutical composition suitable for oral administration, comprising: (a) a S1P receptor agonist; and (b) a sugar alcohol.

    Patent expiration dates:

    • March 29, 2026
      ✓ 
      Drug product
    • September 29, 2026
      ✓ 
      Pediatric exclusivity
  • S1P receptor modulators for treating relasping-remitting multiple sclerosis
    Patent 9,187,405
    Issued: November 17, 2015
    Assignee(s): Novartis AG

    The present invention relates uses of an S1P receptor modulator such as 2-substituted 2-amino-propane-1,3-diol or 2-amino-propanol derivatives, e. g. a compound comprising a group of formula X for the treatment or prevention of neo-angiogenesis associated with a demyelinating disease, e.g. multiple sclerosis.

    Patent expiration dates:

    • June 25, 2027
      ✓ 
      Patent use: TREATMENT OF AUTOIMMUNE DISEASE
    • December 25, 2027
      ✓ 
      Pediatric exclusivity
  • Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol
    Patent 9,592,208
    Issued: March 14, 2017
    Assignee(s): Novartis AG

    A solid pharmaceutical composition suitable for oral administration, comprising: (a) a S1P receptor modulator; (b) a filler, and (c) a cyclodextrin.

    Patent expiration dates:

    • March 30, 2032
      ✓ 
      Patent use: TREATMENT OF MULTIPLE SCLEROSIS IN THE PEDIATRIC PATIENT POPULATION WITH 0.25 MG FINGOLIMOD
      ✓ 
      Drug product
    • September 30, 2032
      ✓ 
      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:

    • May 11, 2021 - NEW PATIENT POPULATION
    • May 11, 2021 - NEW STRENGTH
    • November 11, 2021 - 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.
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