Generic Gilenya Availability

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

GILENYA (fingolimod - capsule;oral)

  • Manufacturer: NOVARTIS
    Approval date: September 21, 2010
    Strength(s): 0.5MG [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: 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.

  • 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
  • Compositions and methods of using compositions with accelerated lymphocyte homing immunosuppressive properties
    Patent 6,004,565
    Issued: December 21, 1999
    Inventor(s): Chiba; Kenji & Adachi; Kunitomo
    Assignee(s): Yoshitomi Pharmaceutical Industries, Ltd.
    The methods and compositions of the invention and the compounds used in the invention involve a novel immunosuppression mechanism, accelerated lymphocyte homing immunosuppression (ALH-immunosuppression). For example, the compound FTY720 specifically directs lymphocytes to the peripheral lymph nodes, mesenteric lymph nodes, and Peyer's patches. By reversibly sequestering lymphocytes in these tissues, the compounds can inhibit an immune response in a mammal. Understanding these mechanisms provides a novel immunosuppression therapy that can synergistically interact with other immunosuppressive compounds. Screening methods for identifying similar ALH-immunosuppression compounds are also described. The invention allows better treatments and therapies wherever an immunosuppression regimen is desired.
    Patent expiration dates:
    • September 23, 2017
      ✓ 
      Patent use: TREATMENT OF AUTOIMMUNE DISEASE
  • 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

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:
    • July 20, 2014 - ADDITION OF THE T1-WEIGHTED GD-ENHANCED LESION EFFICACY VARIABLE IN THE CLINICAL STUDIES SECTION 14 OF THE PACKAGE INSERT
    • September 21, 2015 -

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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