Generic Drug Opportunity Assessment - Fingolimod (Gilenya)

  • ID: 2729083
  • Report
  • Greystone Associates
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This branded drug represents an attractive opportunity for generic drug companies that utilize the provisions under Section 505(j)(2)(A)(vii)(IV) as part of their ANDA-filing strategy.

The Brand

Gilenya (fingolimod) is the first in a new class of multiple sclerosis (MS) therapies called sphingosine 1-phosphate receptor modulators and the first oral therapy approved to treat relapsing-remitting MS (RRMS). In the US, Gilenya is indicated for relapsing forms of MS. In the EU, Gilenya is indicated for adult patients with highly active RRMS defined as either high disease activity despite treatment with beta interferon, or rapidly evolving severe RRMS. A Phase II/III study of Gilenya in patients with chronic inflammatory demyelinating polyradiculoneuropathy was initiated in 2012. In 2012 Gilenya continued to show rapid growth as the first once-daily oral therapy approved for relapsing remitting and/or relapsing forms of multiple sclerosis (MS and RRMS) in adult patients, and achieved $1.2 billion in annual sales.

The Market

Multiple Sclerosis is generally considered an autoimmune disease, caused by immune attack against normal components of the central nervous system. The specificity of the immune attack at the molecular level is determined in each case by the HLA type of the individual patient, and HLA type is known to be one factor that contributes to susceptibility to MS. The dirucotide synthetic peptide is a molecular replicate of the site of attack that is dominant in MS patients with HLA haplotypes DR-2 or DR-4. These HLA types are found in 65-75% of all MS patients.

The market has been dominated by injectables – interferons and more recently Teva’s Copaxone. It is believed that interferon medications such as Rebif, Betaferon, and Avonex are effective against MS because they help regulate the immune system to decrease attacks on myelin. Rebif has been shown to be effective in treating patients with relapsing-remitting MS. The interferons have been shown to reduce relapses in relapsing-remitting MS, though not for primary progressive multiple sclerosis, for which there are currently no disease-modifying treatments proven to be effective.

The landscape for MS treatments is expected to change during the forecast period, as several anticipated new drugs enter the market. The first orally administered disease-modifying therapy, fingolimod (Gilenya), which competes with Copaxone, was approved by the FDA in September 2010. This once-daily drug was approved for the treatment of relapsing remitting multiple sclerosis patients.


This report is part of the Generic Drug Opportunity Reports series. These reports are designed to allow Industry managers to understand and evaluate the market potential for selected branded drugs from the viewpoint of creating and refining FDA ANDA regulatory filings in pursuit of first-filer generic drug applications. Each report contains timely and insightful data and information on drugs that have been approved by the FDA under existing New Drug Applications (NDA), and which have one or more Orange Book listed patents with patent expiration dates that fall in 2016 or beyond, providing interested market participants with a time window to prepare and submit an ANDA filing.

Each Generic Market Opportunity Assessment includes data and analysis on key strategic and tactical factors designed to provide generic drug managers with decision support tools in the form of specific and comprehensive information and data
Note: Product cover images may vary from those shown
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Report Highlights

Gilenya – The Brand
Fingolimod – The Product
Fingolimod – The Market
Fingolimod – The Opportunity
Manufacturing and Sourcing
Gilenya Patents and Exclusivity
Therapeutic Class P4 Certifications
Generic First-to-File Revenue Opportunity
Business Risk Assessment
First-to-File – Probabilistic Scenario
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown