Gilenya

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.

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, 2014
    
    ✓ 
    Patent use: TREATMENT OF AUTOIMMUNE DISEASE
    ✓ 
    Drug substance
  
  

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 - NEW CHEMICAL ENTITY
  
  

See also...

• Gilenya Consumer Information (Drugs.com)
• Gilenya Consumer Information (Wolters Kluwer)
• Gilenya Consumer Information (Cerner Multum)
• Gilenya Advanced Consumer Information (Micromedex)
• Gilenya AHFS DI Monographs (ASHP)
• Fingolimod Consumer Information (Wolters Kluwer)
• Fingolimod Consumer Information (Cerner Multum)
• Fingolimod Advanced Consumer Information (Micromedex)
• Fingolimod Hydrochloride AHFS DI Monographs (ASHP)