Gilenya Generic: When Will Generic Fingolimod Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Gilenya Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? TBD no date yet What opens the door is not settled yet
- Has the FDA approved a generic? December 2019 15 companies approved
- When does the last patent end? September 2032 2 patents listed with the FDA
- Can you buy a generic today? Yes 22 companies list one
It already is. A generic fingolimod hydrochloride is listed for sale by 22 companies, so ask your pharmacy whether it can fill your prescription with one.
What should I do now?
Ask your pharmacy whether it can fill your prescription with a generic. It may look different from Gilenya, but the active ingredient, strength and form are the same. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Gilenya by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Moderate 3 companies have filed, 1 first in line
- Brand sales
- Sales not reported
- FDA approved 2010 September 2010 FDA Orange Book
- Patents listed 2 last runs to September 2032 FDA Orange Book
- Generics FDA-approved 15 companies, the first approved December 2019 FDA Orange Book
- Pharmacies pay $414.71 per capsule, up 20.3% in a year NADAC, March 2026
- Medicare Part D spent $45.9M in 2025, for 466 people CMS Part D Spending by Drug
- Medicaid prescriptions 1,440 in the last four reported quarters, $16.7M CMS Medicaid drug utilization, to Q1 2026
Gilenya’s Road to a Generic
Gilenya has had the market to itself since the FDA approved it in September 2010 (Novartis Pharmaceuticals Corp). Its 2 listed patents run to September 2032. Generic companies have challenged its patents with the FDA since September 2014.
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Gilenya Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Gilenya’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 10,543,179 | A way of using it (U-2719) | December 2027 | Active |
| 9,592,208 | The product’s formulation; a way of using it (U-2315) | September 2032 with the pediatric extension | Active |
Source: FDA Orange Book, application 022527. Patent numbers open the patent on Google Patents.
Patent Challenges to Gilenya
The first patent challenge to Gilenya reached the FDA in September 2014, from 19 companies on that first day. The FDA’s list has 2 entries for Gilenya, by form and strength. A first challenger began selling its generic in September 2022.
What Is a Patent Challenge?
A generic company that wants to sell its version before Gilenya’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Capsules, 0.5 mg | September 2014 | 19 companies | First challenger eligible decided January 2020 | December 2019 | September 2022 | March 2026 |
| Capsules, 0.25 mg | July 2018 | 1 company | First challenger eligible decided November 2021 | November 2021 | Not yet | March 2032 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Fingolimod Hydrochloride
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
At least 15 companies have applied to the FDA to make generic fingolimod hydrochloride.
First in line. One of them was first in line: the first company to challenge the brand’s patents can earn 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Gilenya’s patents with the FDA since September 2014: see the patent challenges.
Approved by the FDA
The FDA has approved generic versions from 15 companies, the first in December 2019. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
For Sale in Pharmacies
Yes. A generic fingolimod hydrochloride is listed for sale by 22 companies. Ask your pharmacy whether it can fill your prescription with it.
Accord Healthcare Inc., Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited, Apotex Corp., Ascend Laboratories, LLC, Aurobindo Pharma Limited and 16 more
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Biocon Ltd | December 2019 | EQ 0.5MG BASE | AB |
| Hetero Labs Ltd Unit V | May 2020 | EQ 0.5MG BASE | AB |
| Glenmark Pharmaceuticals Ltd | June 2020 | EQ 0.5MG BASE | AB |
| Teva Pharmaceuticals USA Inc | July 2020 | EQ 0.5MG BASE, EQ 0.25MG BASE | AB |
| Zydus Pharmaceuticals USA Inc | October 2020 | EQ 0.5MG BASE | AB |
| Accord Healthcare Inc | October 2020 | EQ 0.5MG BASE | AB |
| Apotex Inc | December 2020 | EQ 0.5MG BASE | AB |
| Alkem Laboratories Ltd | December 2020 | EQ 0.5MG BASE | AB |
| Dr Reddys Laboratories Ltd | March 2021 | EQ 0.5MG BASE | AB |
| Hec Pharm Co Ltd | November 2021 | EQ 0.5MG BASE | AB |
| Prinston Pharmaceutical Inc | September 2022 | EQ 0.5MG BASE | AB |
| Bionpharma Inc | May 2023 | EQ 0.5MG BASE | AB |
| Ezra Ventures LLC | December 2023 | EQ 0.5MG BASE | AB |
| Aurobindo Pharma Ltd | February 2024 | EQ 0.5MG BASE | AB |
| Alembic Pharmaceuticals Ltd | April 2026 | EQ 0.5MG BASE | AB |
| Sun Pharmaceutical Industries Ltd discontinued | December 2019 | EQ 0.5MG BASE | – |
| Chartwell Rx Sciences LLC discontinued | June 2020 | EQ 0.5MG BASE | – |
| Mylan Pharmaceuticals Inc discontinued | January 2021 | EQ 0.5MG BASE | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Gilenya Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Gilenya 0.5 mg capsule
$414.71 per capsule in March 2026, up 20.3% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per capsule |
|---|---|
| March 2026 | $414.71 |
| February 2026 | $414.71 |
| January 2026 | $414.71 |
| February 2024 | $344.68 |
| January 2024 | $344.68 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Gilenya today: $414.71 per capsule for Gilenya 0.5 mg capsule in March 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017). Gilenya has 15 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $414.71 pharmacies pay per capsule today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Gilenya
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Gilenya, before manufacturer rebates.
- $10.7M
- January to March 2026, the latest CMS has posted
For 330 people, about $15,562 per prescription fill - $45.9M
- 2025, the whole year
For 466 people, about $13,516 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $10,706,656 | 330 | $15,562.00 |
| 2025 | $45,860,848 | 466 | $13,516.31 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Gilenya only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat multiple sclerosis-MS. It is not a cure for MS but it is thought to help by preventing immune system cells (lymphocytes) from attacking the nerves in your brain and spinal cord.
Medicaid Prescriptions by Quarter
1,440 prescriptions in the four quarters to Q1 2026, $16.7M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 292 | $3,649,146 |
| Q4 2025 | 352 | $4,063,992 |
| Q3 2025 | 401 | $4,558,700 |
| Q2 2025 | 395 | $4,441,193 |
| Q1 2025 | 461 | $4,984,747 |
Source: CMS Medicaid State Drug Utilization Data, over Gilenya’s own package codes.
Gilenya Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 0.5MG BASE | Capsule | Oral | September 2010 | Prescription reference product |
| EQ 0.25MG BASE | Capsule | Oral | May 2018 | Prescription reference product |
Source: FDA Orange Book, Novartis Pharmaceuticals Corp. Listed for sale today by Novartis Pharmaceuticals Corporation (FDA NDC Directory).
Gilenya NDC Codes and Packages
Each Gilenya package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 00078-0965-89 | FINGOLIMOD HYDROCHLORIDE .25 mg/1 capsule | carton of 7 capsules | Novartis Pharmaceuticals Corporation |
| 00078-0965-89 | FINGOLIMOD HYDROCHLORIDE .25 mg/1 capsule | carton of 7 capsules | Novartis Pharmaceuticals Corporation |
| 00078-0607-15 | FINGOLIMOD HYDROCHLORIDE .5 mg/1 capsule | bottle of 30 capsules | Novartis Pharmaceuticals Corporation |
| 00078-0607-15 | FINGOLIMOD HYDROCHLORIDE .5 mg/1 capsule | bottle of 30 capsules | Novartis Pharmaceuticals Corporation |
| 00078-0607-89 | FINGOLIMOD HYDROCHLORIDE .5 mg/1 capsule | carton of 7 capsules | Novartis Pharmaceuticals Corporation |
Source: the FDA NDC Directory, current listings only. Only packages sold under Gilenya’s own FDA approval (NDA 22527) are listed, never a generic. Some codes belong to companies that repackage Gilenya: it is the same medicine in a different package.
What a Generic Gilenya Means for You
Nothing Changes Until It Is in Pharmacies
A generic is listed for sale now, so your pharmacy may already be able to fill your prescription with it.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Questions people ask about Gilenya
Is there a generic for Gilenya right now?
Yes. The FDA NDC Directory lists a generic fingolimod hydrochloride from 22 companies. Ask your pharmacy whether it can fill your prescription with it.
When will Gilenya go generic?
It already has. The FDA NDC Directory lists a generic fingolimod hydrochloride from 22 companies, so ask your pharmacy whether it can fill your prescription with one.
Will generic fingolimod hydrochloride be the same as Gilenya?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. At least 15 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $414.71 pharmacies pay per capsule for Gilenya today to under $20.74. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Gilenya?
Yes. The FDA Orange Book lists approved generic versions from 15 companies, the first approved in December 2019: Biocon Ltd, Hetero Labs Ltd Unit V, Glenmark Pharmaceuticals Ltd, Teva Pharmaceuticals USA Inc and 11 more. Approved is not the same as on sale: patents, a settlement or the company’s own plans can still hold a launch.
When does the Gilenya patent expire?
The FDA Orange Book lists 2 patents for Gilenya; the last runs to September 2032, counting a six-month pediatric extension. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (a date that is not known yet) weighs all of that.
Has anyone challenged the Gilenya patents?
Yes. The first patent challenge to Gilenya reached the FDA in September 2014, from 19 companies on that first day. A first challenger began selling its generic in September 2022. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
How much does Gilenya cost now?
Pharmacies paid about $414.71 per capsule for Gilenya 0.5 mg capsule in March 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected a date that is not known yet on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- JentaduetoLinagliptin and Metformin HydrochlorideJuly to December 2026
- OnuregAzacitidine2027 to 2028
- SovaldiSofosbuvirSeptember 2029
- Vykat XRDiazoxide Choline2034 to 2035
- Aristada InitioAripiprazole LauroxilApril 2039
- EluciremGadopiclenolJanuary 2040
About Gilenya
- Generic name fingolimod hydrochloride
- How it is taken By mouth
- Company Novartis Pharmaceuticals Corp
- Patent challenges Since September 2014 (FDA)
- More drugs Brand-name drugs starting with G
- Have a question? A pharmacist answers, free. Ask about Gilenya
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.