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Generic Gilenya Availability

Last updated on June 8, 2021.

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

Has a generic version of Gilenya been approved?

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

fingolimod hydrochloride capsule;oral

  • Manufacturer: ACCORD HLTHCARE
    Approval date: October 28, 2020
    Strength(s): EQ 0.5MG BASE [AB]
  • Manufacturer: ALKEM LABS LTD
    Approval date: December 30, 2020
    Strength(s): EQ 0.5MG BASE [AB]
  • Manufacturer: APOTEX
    Approval date: December 18, 2020
    Strength(s): EQ 0.5MG BASE [AB]
  • Manufacturer: DR REDDYS
    Approval date: March 5, 2021
    Strength(s): EQ 0.5MG BASE [AB]
  • Manufacturer: GLENMARK PHARMS LTD
    Approval date: June 18, 2020
    Strength(s): EQ 0.5MG BASE [AB]
  • Manufacturer: HETERO LABS LTD V
    Approval date: May 18, 2020
    Strength(s): EQ 0.5MG BASE [AB]
  • Manufacturer: STRIDES PHARMA
    Approval date: June 29, 2020
    Strength(s): EQ 0.5MG BASE [AB]
  • Manufacturer: SUN PHARM
    Approval date: December 4, 2019
    Strength(s): EQ 0.5MG BASE [AB]

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 FAQ.

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.

  • Patent 10,543,179

    Patent expiration dates:

    • December 25, 2027
      ✓ 
      Patent use: TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS BY DETERMINING VARICELLA ZOSTER VIRUS (VZV) STATUS AND VACCINATING PRIOR TO COMMENCING TREATMENT
  • 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 RELAPSING-REMITTING SCLEROSIS (MS)
    • 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 STRENGTH
    • May 11, 2021 - NEW PATIENT POPULATION
    • November 11, 2021 - PEDIATRIC EXCLUSIVITY

Glossary

Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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.

Further information

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