With 14 generic fingolimod capsules on the market,1 can you trust the dice with your medication?
Are generic fingolimod capsules putting you at risk of increased disease activity and relapse?
More disease advancement and higher frequency of side effects reported in patients after they switched from Gilenya® (fingolimod) capsules to generic fingolimod capsules.4
Cases of relapse were reported in patients who had to switch from Gilenya® to generic fingolimod capsules at the request of insurance providers.5
Four FDA-approved generic fingolimod capsules were tested, where two of the four generic products were substandard, containing only 76.8% and 85.5% of the label.6
Four batches of Glenmark Pharmaceuticals Europe’s generic fingolimod capsules were recalled in the UK for being out-of-specification.7
Generic fingolimod capsules from Glenmark Pharmaceuticals USA were tested, to find they only contained 85.4% of the labeled dosage.8
FDA issued Warning Letter and Import Alert for 11 products to Viatris™ (parent company of Mylan®), including generic fingolimod capsules.9
Cases of relapse were reported in patients who had to switch from Gilenya® to generic fingolimod capsules at the request of insurance providers.5
Four batches of Glenmark Pharmaceuticals Europe’s generic fingolimod capsules were recalled in the UK for being out-of-specification.7
FDA issued Warning Letter and Import Alert for 11 products to Viatris™ (parent company of Mylan®), including generic fingolimod capsules.9
More disease advancement and higher frequency of side effects reported in patients after they switched from Gilenya® (fingolimod) capsules to generic fingolimod capsules.4
Four FDA-approved generic fingolimod capsules were tested, where two of the four generic products were substandard, containing only 76.8% and 85.5% of the label.6
Generic fingolimod capsules from Glenmark Pharmaceuticals USA were tested, to find they only contained 85.4% of the labeled dosage.8
Research Overview
Research from the University of Texas Southwestern Medical Center suggests that subpotent generic fingolimod capsules may be putting patients at risk of increased MS activity and relapse.2,3
Research Published in 2026
Data analysis shows outcomes from an expanded data set of 88 individuals. All individuals were treated with Gilenya® capsules for more than one year before switching to generic fingolimod capsules, and had been on generic medication for at least six months.3
Results showed that:
• Relapse rate was approximately five times higher during treatment with generic fingolimod capsules, relative to when on Gilenya® capsules.
• The average time from treatment start to a relapse was shorter on generic fingolimod capsules vs. Gilenya® capsules.
• Rate of the development of side effects per year was 2.45-fold higher during treatment with generic fingolimod capsules.3
| When on Gilenya® (N=88) | When on Generic Fingolimod (N=88) | |
|---|---|---|
| MRI Relapse - no clinical symptoms (number of events) | 2 (2.3%) | 5 (5.7%) |
| Clincal Relapse - symptoms only (number of events) | 0 (0.0%) | 2 (2.3%) |
| Clinical and MRI (number of events) | 0 (0.0%) | 3 (3.4%) |
| Relapse Rate (%) | 2.3% | 11.4% |
| Average Years to relapse (SD) | 6.66 (3.44) | 1.42 (0.55) |
Research Published in 2024
In this study, six individuals with relapsing-remitting MS had relapses around one year after switching from Gilenya® to generic fingolimod capsules.2 A closer look at absolute lymphocyte counts, an indicator of MS activity, and samples of generic fingolimod capsules provided by the individuals showed a connection between disease activity and generic medication that were below FDA standards.2
The study reported:
All six individuals experienced a relapse, including:
Higher lymphocyte counts after treatment switch from Gilenya® to generic fingolimod capsules, an indication of increased disease activity.
A case where a 30-day refill of generic fingolimod capsules consisted of medication from three different manufacturers, consisting of:
What to Know About Generic Fingolimod Capsules
There are 14 FDA-approved generic fingolimod capsules on the market,1 but each product is produced by a different manufacturer at different quality standards. They are all available at pharmacies and substitutable for Gilenya®, which means it is difficult for your healthcare provider to ensure your medication is consistent from month-to-month.
If you have been switched to generic fingolimod capsules make sure you know how to assess your medication. Here are some questions to ask yourself:
- Does the appearance and manufacturer of my capsules change from month-to-month?
- Have I had new or worsening symptoms or adverse effects?
- Am I experiencing any symptoms of MS relapse?
Keep track of any noticeable changes to your medication and symptoms. Providing accurate details to your healthcare provider can help them understand your condition.
Stay informed about your generic fingolimod medication and know how to spot the signs of potentially subpotent medication.
TASCENSO ODT® (fingolimod), the fingolimod you can count on for consistent medication, at the dosage you are prescribed, every time.
- Same proven fingolimod that has the same efficacy and safety as Gilenya®.10
- Not a generic.
- Not AB-rated to Gilenya® and not substitutable at the pharmacy level.1
- Manufactured in the UK, with each and every batch tested and verified, containing 100.3-100.8% of the label.6
- Accompanied by a comprehensive patient support program, Cycle Vita™, which delivers individualized product support* at every step.
MS is unpredictable, but your treatment doesn’t need to be.
Additional Resources
Download our whitepaper to see the assay results of four generic fingolimod capsules.
References
1. FDA. 2026. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Available at: www.accessdata.fda.gov/scripts/cder/ob/index.cfm. [Accessed: January 14 2026].
2. Okuda DT, et al. 2024. Clinical and radiological implications of subpotent generic fingolimod in multiple sclerosis: a case series. Therapeutic Advances in Neurological Disorders. 2024;17, 17562864241300047. Available at: https://doi/10.1177/17562864241300047. [Accessed: November 26 2024].
3. Patel MA, Punnen TG, Shan KS, et al. 2026. Clinical and radiological outcomes of directed treatment transitions from Gilenya® to generic fingolimod. Multiple Sclerosis, 0(0). doi:10.1177/13524585251401404.
4. Menendez, L., et al. 2023. The consequences of switching from Gilenya® to generics for fingolimod. Multiple sclerosis and related disorders, 74, 104692. Available at: https://doi.org/10.1016/j.msard.2023.104692. [Accessed: November 26 2024].
5. REF-00079
6. Wainwright, C, et al. 2023. Fingolimod: Assay analysis of US generic capsule products reveals variation in fingolimod content beyond the recommended acceptance criteria, Multiple Sclerosis and Related Disorders, Volume 80, 105077. Available at: https://doi.org/10.1016/j.msard.2023.105077. [Accessed: November 26 2024].
7. Community Pharmacy England. 2024. MHRA Class 3 Medicines Recall: Fingolimod 0.5 mg Hard Capsules (Glenmark Pharmaceuticals Europe Ltd) – Community Pharmacy England. Available at: https://cpe.org.uk/our-news/mhra-class-3-medicines-recall-fingolimod-0-5-mg-hard-capsules-glenmark-pharmaceuticals-europe-ltd/. [Accessed: November 26 2024].
8. REF-00087
9. Endpoints News. 2024. Viatris’ India-based manufacturing site blocked from shipping 11 generic drugs to US. Available at: https://endpts.com/viatris-india-based-manufacturing-site-blocked-from-shipping-11-generic-drugs-to-us/ [Accessed: January 27 2025].
10. REF-00075
*Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at 888-360-8482.
Gilenya® is a registered trademark of Novartis AG.
Viatris™ is a trademark and Mylan® is a registered trademark of Mylan Inc., a Viatris company.